Rotator Cuff Calcific Tendinitis: Ultrasound-Guided Needling and Lavage Versus Subacromial Corticosteroids Five-Year Outcomes of a Randomized Controlled Trial Pieter Bas de Witte,*y MD, PhD, Arjen Kolk,y MD, Ferdinand Overes,y BSc, Rob G.H.H. Nelissen,y MD, PhD, and Monique Reijnierse,z MD, PhD Investigation performed at the Leiden University Medical Center, Leiden, the Netherlands Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Ga¨rtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 6 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 6 11.9. After a mean follow-up of 5.1 6 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 (P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 (P = .32). There was total resorption in 62% of group 1 and 73% of group 2 (P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Ga¨rtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of followup. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period (P \ .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry). Keywords: rotator cuff; calcific tendinitis; treatment; randomized controlled trial; needling; barbotage
Calcific tendinitis of the rotator cuff (RCCT) is frequently diagnosed, with a reported prevalence between 6.8% and 54% in patients with shoulder pain.17,33,35,36 It is often referred to as a self-limiting disease that can be treated with, for example, physical therapy and analgesics, but its symptoms can be severe and persistent,17,24,35 requiring
more rigorous therapies, including subacromial corticosteroid injections, shockwave therapy, needling and lavage (barbotage), acetic acid iontophoresis, or various surgical techniques.§ However, there is a lack of studies with a high level of evidence and a midterm to long-term follow-up comparing treatment methods. Consequently, the preferred treatment for RCCT remains a subject of debate.
The American Journal of Sports Medicine, Vol. XX, No. X DOI: 10.1177/0363546517721686 Ó 2017 The Author(s)
§
References 1-4, 6-8, 10, 12, 14, 15, 19, 25, 30, 31, 34.
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Previously, we compared the outcomes of ultrasound (US)–guided barbotage combined with a US-guided corticosteroid injection in the subacromial bursa (SAIC) versus an isolated US-guided SAIC in patients with RCCT in a double-blinded randomized controlled trial (RCT) with a follow-up of 1 year.14 At 6 months and 1 year of followup, both clinical and radiological outcomes were significantly superior for barbotage. In the current study, we report the 5-year outcomes of this trial. As RCCT is often referred to as a self-limiting disease, and as observational studies have shown that long-term results of barbotage and more conservative treatments might be more or less comparable, we hypothesized that there would be no more significant differences between the clinical and radiological outcomes of these 2 treatments after 5 years of follow-up.
METHODS The current study reports the clinical and radiological results of an additional 5-year follow-up evaluation of a multicenter double-blinded RCT, with parallel groups and equal (1:1) simple randomization, of which the 1-year results were published previously in this journal.14 Materials and methods are reported in a concise format below. For more detailed information, please see the original study.14 All stages of the study were approved by the institutional medical ethics review board, and all participating patients signed an informed consent form.
Study Population The population for the current study consisted of all consecutive patients with shoulder complaints due to RCCT (.3 mm) who were included in the original trial (n = 48) between March 2010 and December 2011 (Figure 1). Addresses and data on patients’ death were verified using the hospital information system, which is linked to a municipal personal records database. We were able to contact all 48 patients and invited them for additional follow-up evaluations at the outpatient clinic or to fill out questionnaires as sent by mail.
Blinding and Intervention At baseline, all patients underwent a US evaluation by an experienced musculoskeletal radiologist to assess eligibility criteria, (partial) rotator cuff tears, and signs of tendinosis or bursitis. Next, participants were randomized for either US-guided barbotage in combination with a SAIC (group 1) or an isolated US-guided SAIC (group 2).
Figure 1. Study flowchart.
After sterile preparation, included patients received an anesthetic injection in the skin (lidocaine 1%). Next, a 21gauge needle was positioned in the subacromial bursa with US guidance, 1 to 2 cm caudolateral to the acromial tip. For the SAIC, 5 mL of bupivacaine (5 mg/mL; Actavis) and 1 mL of Depo-Medrol (40 mg/mL; Pfizer) were injected. In addition to the SAIC, in group 1, US-guided needling was performed with a 55-mm 18-gauge needle. The needle was introduced into the calcific deposit, which was then flushed using a syringe with saline solution (room temperature). After lavage, repeated perforation of the deposit was performed. Group 2 received only the SAIC. All patients and the coordinating investigator, who was absent during the entire intervention, were blinded for treatment. The postintervention treatment and follow-up protocol were identical in both groups: paracetamol (1000 mg, 4 times a day) combined with celecoxib (100 mg, 2 times a day) for 3 days. In patients with contraindications for celecoxib, 50 mg
*Address correspondence to Pieter Bas de Witte, MD, PhD, Department of Orthopaedics, Leiden University Medical Center, Postzone J11R, Postbus 9600, 2300 RC Leiden, the Netherlands (email: [email protected]). y Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands. z Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands. One or more of the authors has declared the following potential conflict of interest or source of funding: This study is part of a larger project funded by ZonMw, the Netherlands Organisation for Health Research and Development (grant No. 40-00703-98-8564), and the Dutch Arthritis Association (grant No. 09-1-303).
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tramadol was prescribed 3 times a day. Patients were instructed to use an icepack on the shoulder when experiencing pain in the days after the intervention. In case of persisting symptoms and no signs of resorption at 6 months or longer after the index procedure, patients underwent barbotage (ie, a second barbotage procedure in group 1 patients) or surgery, depending on the preference of the referring orthopaedic surgeon and the patient. The principal investigator and the patients remained blinded for the initial study intervention.
Follow-up All patients had regular follow-up visits with the coordinating investigator (P.B.d.W.) during the first year of follow-up, as described previously (6 weeks, 3 months, 6 months, and 1 year after the intervention).14 For the current study, patients underwent an additional 5-year follow-up evaluation between December 2015 and May 2016 with the same coordinating investigator or a colleague (A.K.) at the orthopaedics outpatient clinic. The clinical status was assessed at each follow-up moment with the Constant score (CS; primary outcome),13 the Disabilities of the Arm, Shoulder and Hand (DASH),18 and the Western Ontario Rotator Cuff Index (WORC).28 If patients could not come to the outpatient clinic, the WORC and DASH were sent by mail. Standard shoulder radiographs (anteroposterior view in internal and external rotation and axial view) were obtained immediately before the index procedure, at 1 year, at 5 years, and if necessary, on clinical indication. Calcific deposits were characterized using the Ga¨rtner classification as follows22: type I calcifications have a sharp border and a dense structure, type II calcifications either have a sharp border and inhomogeneous structure or a vague border and a homogeneous structure, and type III calcifications have a cloudy appearance with a vague border and a transparent structure. Affected tendons and the number of deposits were determined, and all deposits were measured for size (mm). In case of multiple calcifications, the characteristics of the largest baseline calcification were entered in the statistical analyses. For the current study, patients underwent an additional US evaluation at 5 years by an experienced musculoskeletal radiologist (M.R.), who was blinded for the initial study intervention, to assess the same parameters as at baseline14: bursitis (eg, effusion, hypervascularization, thickened bursa), tendinosis, and rotator cuff tear (partial or full thickness).
Statistical Analysis The original sample size calculation of this trial indicated that a group size of 40 participants was needed to find a clinically significant difference of 10.0 points in the CS, as reported in our previous publication.14 Data were expressed as means and SDs or medians and ranges where relevant. Correlations of baseline calcification characteristics (size, Ga¨rtner classification) and clinical baseline
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scores (CS, WORC, DASH) were assessed with Pearson correlation coefficients. Independent Student t tests were applied to compare final follow-up total CS scores and improvement (difference from baseline) scores between both groups. Improvement scores were also assessed, stratified for the baseline Ga¨rtner classification and treatment. Additionally, linear regression analysis was performed with the CS at final follow-up as a dependent variable, taking into account the treatment method, baseline CS, baseline Ga¨rtner classification, and interaction terms. Similar analyses were used for the WORC and DASH. Proportions of patients who underwent additional treatment (ie, barbotage or surgery) during the follow-up period for persisting symptoms and resorption rates (proportions of participants with either partial resorption [a decrease in Ga¨rtner classification and/or calcification size] or total resorption) were compared with Fisher exact tests. Linear regression analysis was performed to assess the effect of total versus partial/no resorption on the final primary outcome (CS), with the applied treatment method as a factor. A mixed model with a random effect for each patient (repeated measures) was used to evaluate postintervention clinical scores at all follow-up moments and associations with the treatment method, baseline Ga¨rtner classification, and baseline clinical scores. The CS, WORC, and DASH were each applied as a dependent variable. Follow-up moment, baseline clinical score, baseline Ga¨rtner classification, and the interaction terms between the treatment method and follow-up moment and baseline Ga¨rtner classification were applied as independent variables. Analyses were performed according to the intention-totreat principle. As a sensitivity analysis, we also applied a per-protocol analysis, with a similar approach and statistical models. SPSS Statistics 24.0 software (IBM) was used for statistical analyses, and P values \.05 were interpreted as statistically significant.
RESULTS Baseline Characteristics The baseline population was similar to the previous study, with 48 patients (25 female) and a mean age of 52.0 6 7.3 years. See Tables 1 and 2 for baseline demographics, clinical scores, and radiological characteristics. No clinically relevant or statistically significant associations were found between radiological characteristics and baseline clinical scores (data not shown), but there was a significant correlation between the calcification size and Ga¨rtner classification, with a Pearson correlation coefficient of –0.32 (P = .03); that is, calcifications with a higher Ga¨rtner classification were on average smaller in size. The baseline US evaluation showed signs of bursitis in 14 patients. Six patients had signs of rotator cuff tendinosis, and there were partial rotator cuff tears in 3 patients: 1 supraspinatus, 1 infraspinatus, and 1 combined supraspinatus and infraspinatus. There were no full-thickness rotator cuff tears.
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TABLE 1 Baseline Characteristicsa
Age, y Sex, male/female, n Body mass index, kg/m2 Affected side, right/left, n Dominant side affected, yes/no, n Baseline clinical scores WORC DASH Constant score VAS for rest VAS for activities of daily living
All Patients (N = 48)
Group 1: Barbotage and SAIC (n = 23)
Group 2: SAIC (n = 25)
52.0 6 7.3 23/25 25.7 6 3.3 35/13 31/17
53.7 6 7.3 11/12 27.0 6 3.2 16/7 15/8
50.4 6 7.2 12/13 24.7 6 3.0 19/6 16/9
45.8 36.9 68.7 40.0 49.2
50.3 32.7 71.6 33.4 42.5
41.6 40.7 66.0 46.0 55.3
6 6 6 6 6
19.7 17.3 11.9 24.3 21.5
6 6 6 6 6
20.1 17.6 12.2 23.2 23.6
6 6 6 6 6
18.7 16.4 11.2 24.2 17.7
a Data are presented as mean 6 SD unless otherwise specified. DASH, Disabilities of the Arm, Shoulder and Hand; SAIC, corticosteroid injection in the subacromial bursa; VAS, visual analog scale (score of 100 being severe pain); WORC, Western Ontario Rotator Cuff Index.
TABLE 2 Baseline Findings From Radiological Evaluationa All Patients (N = 48) No. of calcifications 1 2 .2 .1 tendon involved Affected tendon Supraspinatus Infraspinatus Subscapularis Teres minor Classification of calcificationb Ga¨rtner type I Ga¨rtner type II Ga¨rtner type III Size of calcification,b mean 6 SD, mm
Group 1: Barbotage and SAIC (n = 23)
Group 2: SAIC (n = 25)
30 15 3 7
(62.5) (31.3) (6.3) (14.6)
18 5 0 3
(78.3) (21.7) (0.0) (13.0)
12 10 3 4
(48.0) (40.0) (12.0) (16.0)
36 16 4 0
(75.0) (33.3) (8.3) (0.0)
17 7 1 0
(73.9) (30.4) (4.3) (0.0)
19 9 3 0
(76.0) (36.0) (12.0) (0.0)
20 (41.7) 22 (45.8) 6 (12.5) 14.2 6 5.5
11 (47.8) 9 (39.1) 3 (13.0) 14.5 6 4.7
9 (36.0) 13 (52.0) 3 (12.0) 13.9 6 6.1
a
Data are presented as n (%) unless otherwise specified. SAIC, corticosteroid injection in the subacromial bursa. Values are based on observations of the largest calcific deposit in each patient.
b
Follow-up, Complications, and Additional Treatment
Final Follow-up Evaluation
As reported in the previous publication, no patients were lost to follow-up in the first year. Between the 1-year and 5-year evaluation, 1 patient from group 2 refused to participate, and 4 patients only wanted to participate with questionnaires by mail (2 in group 1 and 2 in group 2). All others were evaluated at the outpatient clinic. Overall, there were no serious adverse events or complications. Two patients developed frozen shoulder syndrome after barbotage, but symptoms declined during the first year of follow-up. During the complete 5-year follow-up period, 20 patients underwent additional treatment (15 in the first year): 4 in group 1 (3 barbotage [ie, second barbotage procedure] and 1 surgery) and 16 in group 2 (13 barbotage and 3 surgery) (P \ .001). This was despite successful perforation in all 23 patients who were primarily treated with barbotage (group 1) and successful aspiration and/or fragmentation in 19 (82.6%).
After a mean follow-up of 5.1 6 0.5 years, the mean CS was 90 (95% CI, 83.0 to 95.9) in group 1 versus 87 (95% CI, 80.5 to 93.5) in group 2, leading to a mean difference of 3 (95% CI, –6.4 to 11.3) (P = .58). There was a statistically significant improvement in the CS of 18 (95% CI, 12.3 to 23.0) in group 1 and 21 (95% CI, 16.2 to 26.2) in group 2, with respect to baseline scores, leading to a mean difference of –4 (95% CI, –10.6 to 3.6) (P = .32). Similar results were observed for the total WORC and DASH scores and improvement in WORC and DASH scores, without statistically significant differences between the treatment groups (Table 3). Stratified for the baseline Ga¨rtner classification and treatment, results were best for patients with type I calcifications who were treated in group 2, as expressed in an improvement of the CS (mean difference between treatment groups: 13 [95% CI, –0.3 to 26.4]; P = .06). For any
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TABLE 3 Clinical Scores and Improvement at 5-Year Follow-upa
Constant score Total score Improvement WORC Total score Improvement DASH Total score Improvement
Group 1: Barbotage and SAIC
Group 2: SAIC
Difference
Mean (95% CI)
Mean (95% CI)
Mean (95% CI)
P Value
89.5 (83.0 to 95.9) 17.7 (12.3 to 23.0)
87.0 (80.5 to 93.5) 21.2 (16.2 to 26.2)
2.5 (–6.4 to 11.3) –3.5 (–10.6 to 3.6)
.58 .32
83.2 (71.9 to 94.4) 32.9 (23.9 to 41.8)
79.0 (68.0 to 89.9) 38.2 (28.1 to 48.4)
4.2 (–11.0 to 19.4) –5.4 (–18.6 to 7.8)
.58 .42
12.7 (3.5 to 21.8) –19.2 (–26.1 to –12.2)
18.0 (8.7 to 27.3) –23.5 (–31.4 to –15.5)
–5.3 (–18.0 to 7.3) 4.3 (–6.0 to 14.7)
.40 .40
a
Differences between groups were calculated with independent Student t tests. DASH, Disabilities of the Arm, Shoulder and Hand; SAIC, corticosteroid injection in the subacromial bursa; WORC, Western Ontario Rotator Cuff Index.
Figure 2. Improvement in the Constant score at 5 years of follow-up in both treatment groups, stratified for the baseline Ga¨rtner classification. of the other baseline calcification classifications, there were no statistically significant or clinically relevant differences in CS improvement scores between the treatment groups (Figure 2). With regression analysis, we assessed the treatment effect at final follow-up, taking into account baseline scores and the Ga¨rtner classification. There was a significant effect for the baseline CS, with an effect size of 0.8 (95% CI, 0.51-1.11): that is, a 10-point higher baseline score was associated with a mean additional 8 points at final follow-up. The mean treatment effect for barbotage was 2
(95% CI, –15.7 to 19.6; P = .83). There was a clinically relevant positive effect size for a baseline Ga¨rtner type I classification, with 15 (95% CI, –0.3 to 30.8; not significant) on the final CS. The interaction between treatment method and Ga¨rtner type I classification had an effect size of –14 (95% CI, –34.5 to 7.0) for barbotage. Hence, as with the stratified analyses, results appeared better for Ga¨rtner type I calcifications treated with a SAIC in our data (not significant), but there were no signs of significant effects for other Ga¨rtner classifications and interactions with the treatment method. Results were similar for the WORC and DASH: effect sizes of 0.8 (95% CI, 0.43-1.09) for the baseline WORC score and 0.8 (95% CI, 0.51-1.12) for the baseline DASH score, no significant effects for the treatment method, and positive (not significant) effects for a Ga¨rtner type I classification at baseline combined with a negative interaction term for barbotage and Ga¨rtner type I classification (not significant). With regard to the radiological outcomes, there was total resorption of all calcifications in 13 of 21 (62%) available patients in group 1 and 16 of 22 (73%) available patients in group 2 (P = .45). There was partial resorption in 7 patients in group 1 and 5 patients in group 2. The mean calcification size decreased by 13.2 mm in group 1 versus 13.5 mm in group 2 (P = .86). Overall, patients with total resorption at 5 years had a CS of 10 points higher (95% CI, 1.4-19.1), without a significant effect for the treatment method. The US evaluation at 5 years revealed 3 intrasubstance supraspinatus tears at former calcification sites (1 in group 1 and 2 in group 2), 1 pre-existing partial supraspinatus tear in group 2, 1 new partial subscapularis tear in group 1, and 1 new full-thickness combined supraspinatus/infraspinatus tear in group 2. Furthermore, we found signs of bursitis in 3 patients in group 1. In group 2, we found signs of bursitis in 3 patients, which was combined with rotator cuff tendinosis in 1. One patient in group 2 had tendinosis of the supraspinatus without other findings. We found no associations between these radiological outcomes and final clinical scores.
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Figure 3. Clinical course expressed in the (A) Constant score (CS), (B) Western Ontario Rotator Cuff Index (WORC), and (C) Disabilities of the Arm, Shoulder and Hand (DASH) after the treatment of calcific tendinitis of the rotator cuff with either barbotage and an ultrasound-guided corticosteroid injection in the subacromial bursa (SAIC; group 1) or an isolated ultrasound-guided SAIC (group 2).
Mixed Model (Repeated Measures of Complete Follow-up Period) The course of clinical scores in each treatment group is displayed in Figure 3. With mixed-model analysis, the mean effect for barbotage versus a SAIC on the CS was 6 (95% CI, –8.9 to 21.5). The baseline CS effect was 0.7 (95% CI, 0.49-0.95) for each additional pretreatment point. There was a significant effect for each follow-up moment on the CS (data not shown). The interaction between treatment
method and follow-up was significant for the 1-year followup moment in favor of barbotage: 11 (95% CI, 1.4-19.5). Hence, as demonstrated in Figure 3A, there were higher overall clinical scores for barbotage at 6 weeks, followed by lower scores at 3 months. From 6 months to 1 year, there were higher scores in group 1 compared with group 2. At 5 years, there were no more clinically relevant or statistically significant differences between the groups. Ga¨rtner classification and interaction with the treatment method had no significant effects. Estimated clinical outcomes expressed
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Figure 4. Estimated Constant scores (baseline, 6 weeks, 3 months, 6 months, 1 year, 5 years) of the averaged group of patients with calcific tendinitis of the rotator cuff, based on mixed-model analysis. in the CS for the averaged RCCT patient group based on the mixed model are displayed in Figure 4. For the WORC, similar results were found: the overall treatment effect was 19 (95% CI, –6.7 to 42.7) for barbotage versus a SAIC. The effect size of the baseline WORC score was 0.8 (95% CI, 0.55-0.99). Similar observations were found for the DASH, with only a significant effect for the baseline DASH score: 0.8 (95% CI, 0.64-1.00).
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Figure 5. Clinical course expressed in the Constant score with the per-protocol approach. In this analysis, only patients who did not undergo additional barbotage or surgery during the follow-up period were included, leaving 19 patients in group 1 (barbotage and ultrasound-guided corticosteroid injection in the subacromial bursa [SAIC]) and 8 patients in group 2 (ultrasound-guided SAIC). intention-to-treat approach. Differences between the groups were calculated with independent Student t tests (Table 4).
Per-Protocol Approach
DISCUSSION
Only patients who did not undergo additional barbotage or surgery during the follow-up period were included in a sensitivity analysis, leaving 19 patients in group 1 and 8 patients in group 2. t tests comparing total scores as well as improvement scores at the final evaluation showed no statistically significant differences between the treatment groups for the CS, DASH, and WORC. Overall, similar improvement was observed as in the intention-to-treat analysis (Table 4). The mean decrease in calcification size was 12.2 mm in group 1 and 11.9 mm in group 2 (mean difference, 0.4 mm [95% CI, –6.4 to 7.1]; P = .72). With linear regression analysis for the 5-year results, the effects for baseline scores were again significant for the CS (0.7; P = .002), WORC (0.8; P = .002), and DASH (0.8; P \ .001). There were no significant effects for the treatment method and baseline Ga¨rtner classification. For the complete follow-up (Figure 5), mixed-model analysis resulted in significant effects for baseline scores and additional significant effects for follow-up moments on clinical scores (data not shown), comparable with those of the
The results of this 5-year follow-up RCT showed that there are no statistically significant differences in the clinical and radiological midterm outcomes of US-guided barbotage combined with a SAIC (5 mL of bupivacaine [5 mg/mL] and 1 mL of Depo-Medrol [40 mg/mL]) compared with an isolated US-guided SAIC in patients with RCCT. There was a statistically significant and clinically relevant improvement in both groups in terms of clinical scores and radiological resorption rates compared with baseline. This is in contrast to our previous publication of the 1-year results of this RCT, showing significantly superior results for barbotage compared with a SAIC.14 The previous publication with 1-year results14 was the first RCT assessing barbotage for RCCT, and to our knowledge, as supported by a recent systematic review by Louwerens et al,31 there are no other RCTs on barbotage available with a follow-up period of more than 1 year. A positive long-term effect of barbotage can be more or less expected, based on our previous results and the literature. However, it might be surprising that we observed similar
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TABLE 4 Clinical Scores and Improvement at 5-Year Follow-up in Per-Protocol Analysisa
Constant score Total score Improvement WORC Total score Improvement DASH Total score Improvement
Group 1: Barbotage and SAIC
Group 2: SAIC
Difference
Mean (95% CI)
Mean (95% CI)
Mean (95% CI)
P Value
90.7 (84.2 to 97.1) 16.9 (11.0 to 22.9)
85.9 (69.0 to 102.7) 23.6 (9.9 to 37.3)
4.8 (–8.6 to 18.2) –6.6 (–18.3 to 5.1)
.47 .25
83.0 (69.9 to 96.1) 32.2 (21.5 to 42.9)
79.3 (55.6 to 103.0) 41.9 (18.0 to 65.8)
3.7 (–20.2 to 27.5) –9.7 (–30.7 to 11.3)
.75 .35
11.7 (1.5 to 21.9) –19.1 (–27.5 to –10.6)
19.5 (–1.2 to 40.2) –28.0 (–45.7 to –10.4)
–7.8 (–26.9 to 11.4) 9.0 (–7.1 to 25.0)
.41 .26
a
Only patients who did not undergo additional barbotage or surgery during the follow-up period were included in these analyses, leaving 19 patients in group 1 and 8 in group 2. DASH, Disabilities of the Arm, Shoulder and Hand; SAIC, corticosteroid injection in the subacromial bursa; WORC, Western Ontario Rotator Cuff Index.
and good clinical outcomes in group 2 after 5 years. This could be partly explained by US guidance of the SAIC, regular and frequent follow-up visits with the same doctor, and the natural (often self-limiting) course of RCCT.34,35 There could be confounding due to the relatively high number of patients in group 2 who underwent additional treatment after a minimum of 6 months of follow-up. Nevertheless, the per-protocol analysis showed similar results. Follow-up radiographs at 5 years showed full or partial resorption of calcific deposits in 95% of the patients (62% full resorption in group 1 and 73% in group 2). It has been described that the outcomes of barbotage are better with ill-defined calcifications (eg, Ga¨rtner type II or III classification) and that these types of calcifications can be resistant to more conservative treatments.21 However, others reported that type III calcifications actually have a higher possibility of spontaneous resorption.5,33 Also, where we found better 1-year outcomes of barbotage for patients with baseline Ga¨rtner type II or III calcifications in our previous study, there were no such associations in the current study with 5 years’ follow-up. Remarkably, we found better results for a SAIC in patients with a baseline Ga¨rtner type I calcification, but without statistical significance. Additionally, conclusions must be drawn with care for these subgroup analyses in a relatively small patient cohort, including participants who underwent additional treatment during the follow-up period. Lastly, it has been reported that patients with radiological improvement over time report better clinical results.29 Concordantly, in the current study, we found better results in patients with complete resorption, compared with patients with partial or no resorption, regardless of the applied treatment method. The US evaluation at 5 years revealed 3 intrasubstance rotator cuff tears at former calcification sites. Only 1 patient in group 2 (female, 47 years old at inclusion, additional barbotage after 1 year) developed a full-thickness combined supraspinatus and infraspinatus tendon tear during the follow-up period. Thus, calcific resorption and barbotage were not clearly associated with rotator cuff tendon disruption after 5 years. In both groups, there was
a relatively high prevalence of signs of bursitis (n = 6; combined with tendinosis in 1). However, these findings were not associated with inferior clinical outcomes. The literature on the long-term outcomes of barbotage as well as conservative treatments is limited and only available in retrospective and descriptive studies. However, the observed similar 5-year results of a SAIC and barbotage in this RCT are in concordance with the literature. In an observational study, Serafini et al34 reported superior results for barbotage in the first year and comparable good clinical outcomes for barbotage and more conservative treatment methods after 5 to 10 years. In another observational study, conducted by our group, similar long-term clinical results for barbotage and more conservative methods were found as well after a mean follow-up of 14 years.15 In this latter study, however, 42% of the respondents indicated persisting symptoms (long-term WORC score \60) in both treatment groups. Differences with respect to the good overall results of the current study might be caused by, for example, confounding by indication in the mentioned observational study, the standardized and intensive follow-up with a low dropout rate in this RCT, and differences in age and the duration of follow-up. Furthermore, it must be noted that there was no radiological evaluation of potential causes for persisting symptoms in the observational study (eg, rotator cuff tear, persisting/recurrent calcifications, alternative shoulder condition). Although a SAIC, with or without US guidance, is a frequently applied treatment for shoulder symptoms,25,30 we found no other studies assessing its midterm and longterm effectiveness, specifically in patients with RCCT. A SAIC is easy to perform, is low in cost, and has a low complication rate. It can be performed under US guidance for more accuracy, although clinical benefits compared with blind injections have not been objectified for subacromial pain syndrome.11 In the current RCT, patients in group 2 had statistically significant and clinically relevant improvement in the first 6 weeks, but symptoms recurred between 6 weeks and 6 months after treatment. After this period, there was a steadily overall improvement up
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to the level of clinical scores in group 1 at 5 years. However, after 6 months, a relatively high number of patients in group 2 underwent additional treatment, including barbotage. In group 1, a similar course was observed up to 3 months, but this was followed by faster further clinical improvement compared with group 2. The temporary recurrence of symptoms around 3 months has been reported earlier for barbotage.16 Possibly, there is short-term improvement, followed by recurring symptoms, due to a temporary effect of subacromial corticosteroids combined with resorptive-stage RCCT in the months after barbotage. Barbotage is slightly more invasive than a SAIC but is safe and generally well tolerated. It can be performed in the outpatient clinic under local anesthesia. There is much debate in the literature about single- or double-needle techniques, but there is no evidence for differences in outcomes.23,31 At the time of its introduction (around 1937), barbotage was performed under fluoroscopic guidance.12,32 Over the past decades, barbotage has increasingly been performed under US guidance. There is no radiation; the localization of calcifications is more accurate; and the rotator cuff, bursa, and biceps tendon and possible comorbidities in these structures can be visualized for differential diagnostic purposes.20 There are several alternatives for barbotage and a SAIC. In particular, extracorporeal shockwave therapy (ESWT) is the subject of numerous publications on RCCT. Yet again, there is a lack of studies with larger patient groups, longterm follow-ups, or prospective or comparative study designs. We found one trial comparing ESWT and barbotage in which Kim et al27 reported more effective pain relief and functional restoration for barbotage in the short term. In an observational study, Cho et al9 reported radiological success rates of 15% to 70% for ESWT, 28% to 76% for barbotage, and around 72% for surgery. Also, in a recent systematic review by Louwerens et al,31 it was concluded that good to excellent clinical outcomes can be achieved after high-energy ESWT but also after barbotage and arthroscopic surgery. More comparative studies with a long-term follow-up are needed to gain more information on the indications and differences in outcomes between ESWT and barbotage. On the basis of the current literature, both can be considered as a next step in the treatment of RCCT when more conservative methods are unsuccessful. A SAIC can also be considered, but more as an initial symptom treatment, guiding the natural course to improvement in the long term. Based on our results, barbotage is associated with faster improvement and a lower number of patients needing additional treatment compared with a SAIC. Surgery needs to be regarded as a last resort.9,26 Reported clinical results are good, but infections, rotator cuff tears, and other complications have been reported (5.8%-9.5%), and a longer hospital stay is needed.37 Limitations of the current study are similar to those in the previous publication.14 Twenty patients underwent additional barbotage or surgery during the complete follow-up period (16 in group 2 [P \ .001]), with 5 of them between 1 and 5 years. We accounted for this in the per-protocol analysis, but it is actually an important outcome of this study as well, indicating that patients treated with only SAIC are more likely to undergo additional treatment during follow-up. Furthermore, there is a bigger chance of patients having been unblinded
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during this longer follow-up period. However, the investigating researchers were blinded throughout the complete study. Lastly, a limitation reported in the previous publication was that the decline of symptoms and resolution of calcifications could take longer than 1 year, according to the literature and the results at the time. This limitation is not relevant anymore in the current study. In conclusion, this is the first double-blinded RCT comparing midterm clinical and radiological results of barbotage combined with a SAIC versus an isolated SAIC in patients with RCCT. Where clinical and radiological outcomes were significantly superior for barbotage after 1 year of follow-up, no more differences were found after 5 years. In case of persisting or severe symptoms and no signs of spontaneous resorption, barbotage and a SAIC might both lead to significant improvement in the long term, but based on our results, faster improvement can be expected with barbotage, with a lower chance of needing additional treatment during the follow-up period.
ACKNOWLEDGMENT The authors acknowledge the colleagues and secretaries of the Departments of Orthopaedics and Radiology at the Leiden University Medical Center for their help in the logistics and planning of the patients. REFERENCES 1. Aina R, Cardinal E, Bureau NJ, Aubin B, Brassard P. Calcific shoulder tendinitis: treatment with modified US-guided fine-needle technique. Radiology. 2001;221:455-461. 2. Albert JD, Meadeb J, Guggenbuhl P, et al. High-energy extracorporeal shock-wave therapy for calcifying tendinitis of the rotator cuff: a randomised trial. J Bone Joint Surg Br. 2007;89:335-341. 3. Ark JW, Flock TJ, Flatow EL, Bigliani LU. Arthroscopic treatment of calcific tendinitis of the shoulder. Arthroscopy. 1992;8:183-188. 4. Berg E. Calcific tendinitis of the shoulder. Orthop Nurs. 1997;16:68-69. 5. Bosworth DM. Calcium deposits in the shoulder and subacromial bursitis: a survey of 12,122 shoulders. JAMA. 1941;116:2477-2482. 6. Cacchio A, De BE, Desiati P, Spacca G, Santilli V, De PF. Effectiveness of treatment of calcific tendinitis of the shoulder by disodium EDTA. Arthritis Rheum. 2009;61:84-91. 7. Cacchio A, Paoloni M, Barile A, et al. Effectiveness of radial shockwave therapy for calcific tendinitis of the shoulder: single-blind, randomized clinical study. Phys Ther. 2006;86:672-682. 8. Chaudhry HJ. Ultrasound therapy for calcific tendinitis of the shoulder. N Engl J Med. 1999;341:1237. 9. Cho NS, Lee BG, Rhee YG. Radiologic course of the calcific deposits in calcific tendinitis of the shoulder: does the initial radiologic aspect affect the final results? J Shoulder Elbow Surg. 2010;19:267-272. 10. Ciccone CD. Does acetic acid iontophoresis accelerate the resorption of calcium deposits in calcific tendinitis of the shoulder? Phys Ther. 2003;83:68-74. 11. Cole BF, Peters KS, Hackett L, Murrell GA. Ultrasound-guided versus blind subacromial corticosteroid injections for subacromial impingement syndrome: a randomized, double-blind clinical trial. Am J Sports Med. 2016;44:702-707. 12. Comfort TH, Arafiles RP. Barbotage of the shoulder with imageintensified fluoroscopic control of needle placement for calcific tendinitis. Clin Orthop Relat Res. 1978;135:171-178. 13. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;214:160-164.
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14. de Witte PB, Selten JW, Navas A, et al. Calcific tendinitis of the rotator cuff: a randomized controlled trial of ultrasound-guided needling and lavage versus subacromial corticosteroids. Am J Sports Med. 2013;41:1665-1673. 15. de Witte PB, van Adrichem RA, Selten JW, Nagels J, Reijnierse M, Nelissen RG. Radiological and clinical predictors of long-term outcome in rotator cuff calcific tendinitis. Eur Radiol. 2016;26(10):3401-3411. 16. Del Cura JL, Torre I, Zabala R, Legorburu A. Sonographically guided percutaneous needle lavage in calcific tendinitis of the shoulder: shortand long-term results. AJR Am J Roentgenol. 2007;189:W128-W134. 17. Diehl P, Gerdesmeyer L, Gollwitzer H, Sauer W, Tischer T. [Calcific tendinitis of the shoulder]. Orthopade. 2011;40:733-746. 18. Dixon D, Johnston M, McQueen M, Court-Brown C. The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) can measure the impairment, activity limitations and participation restriction constructs from the International Classification of Functioning, Disability and Health (ICF). BMC Musculoskelet Disord. 2008;9:114. 19. Ebenbichler GR, Erdogmus CB, Resch KL, et al. Ultrasound therapy for calcific tendinitis of the shoulder. N Engl J Med. 1999;340: 1533-1538. 20. Farin PU, Jaroma H, Soimakallio S. Rotator cuff calcifications: treatment with US-guided technique. Radiology. 1995;195:841-843. 21. Farin PU, Rasanen H, Jaroma H, Harju A. Rotator cuff calcifications: treatment with ultrasound-guided percutaneous needle aspiration and lavage. Skeletal Radiol. 1996;25:551-554. 22. Ga¨rtner J, Simons B. Analysis of calcific deposits in calcifying tendinitis. Clin Orthop Relat Res. 1990;254:111-120. 23. Gatt DL, Charalambous CP. Ultrasound-guided barbotage for calcific tendonitis of the shoulder: a systematic review including 908 patients. Arthroscopy. 2014;30:1166-1172. 24. Gosens T, Hofstee DJ. Calcifying tendinitis of the shoulder: advances in imaging and management. Curr Rheumatol Rep. 2009;11:129-134. 25. Goupille P, Sibilia J. Local corticosteroid injections in the treatment of rotator cuff tendinitis (except for frozen shoulder and calcific tendinitis). Groupe Rhumatologique Francais de l’Epaule (G.R.E.P.). Clin Exp Rheumatol. 1996;14:561-566.
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26. Hurt G, Baker CL Jr. Calcific tendinitis of the shoulder. Orthop Clin North Am. 2003;34:567-575. 27. Kim YS, Lee HJ, Kim YV, Kong CG. Which method is more effective in treatment of calcific tendinitis in the shoulder? Prospective randomized comparison between ultrasound-guided needling and extracorporeal shock wave therapy. J Shoulder Elbow Surg. 2014;23: 1640-1646. 28. Kirkley A, Alvarez C, Griffin S. The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: the Western Ontario Rotator Cuff Index. Clin J Sport Med. 2003;13:84-92. 29. Krasny C, Enenkel M, Aigner N, Wlk M, Landsiedl F. Ultrasoundguided needling combined with shock-wave therapy for the treatment of calcifying tendonitis of the shoulder. J Bone Joint Surg Br. 2005;87:501-507. 30. Lam F, Bhatia D, van Rooyen K, de Beer JF. Modern management of calcifying tendinitis of the shoulder. Curr Orthop. 2006;20:446-452. 31. Louwerens JK, Veltman ES, van NA, van den Bekerom MP. The effectiveness of high-energy extracorporeal shockwave therapy versus ultrasound-guided needling versus arthroscopic surgery in the management of chronic calcific rotator cuff tendinopathy: a systematic review. Arthroscopy. 2016;32:165-175. 32. Patterson RL, Darrach W. Treatment of acute bursitis by needle irrigation. J Bone Joint Surg Am. 1937;19:993-1002. 33. Rupp S, Seil R, Kohn D. [Tendinosis calcarea of the rotator cuff]. Orthopade. 2000;29:852-867. 34. Serafini G, Sconfienza LM, Lacelli F, Silvestri E, Aliprandi A, Sardanelli F. Rotator cuff calcific tendonitis: short-term and 10-year outcomes after two-needle us-guided percutaneous treatment. Nonrandomized controlled trial. Radiology. 2009;252:157-164. 35. Speed CA, Hazleman BL. Calcific tendinitis of the shoulder. N Engl J Med. 1999;340:1582-1584. 36. Uhthoff HK, Sarkar K. Calcifying tendinitis. Baillieres Clin Rheumatol. 1989;3:567-581. 37. Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic shoulder surgery. Arthroscopy. 2002;18:88-95.
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Calcific tendinitis of the rotator cuff (RCCT) is frequently diagnosed, with a reported prevalence between 6.8% and 54% in patients with shoulder pain.17,33,35,36 It is often referred to as a self-limiting disease that can be treated with, for example, physical therapy and analgesics, but its symptoms can be severe and persistent,17,24,35 requiring
more rigorous therapies, including subacromial corticosteroid injections, shockwave therapy, needling and lavage (barbotage), acetic acid iontophoresis, or various surgical techniques.§ However, there is a lack of studies with a high level of evidence and a midterm to long-term follow-up comparing treatment methods. Consequently, the preferred treatment for RCCT remains a subject of debate.
The American Journal of Sports Medicine, Vol. XX, No. X DOI: 10.1177/0363546517721686 Ó 2017 The Author(s)
§
References 1-4, 6-8, 10, 12, 14, 15, 19, 25, 30, 31, 34.
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Previously, we compared the outcomes of ultrasound (US)–guided barbotage combined with a US-guided corticosteroid injection in the subacromial bursa (SAIC) versus an isolated US-guided SAIC in patients with RCCT in a double-blinded randomized controlled trial (RCT) with a follow-up of 1 year.14 At 6 months and 1 year of followup, both clinical and radiological outcomes were significantly superior for barbotage. In the current study, we report the 5-year outcomes of this trial. As RCCT is often referred to as a self-limiting disease, and as observational studies have shown that long-term results of barbotage and more conservative treatments might be more or less comparable, we hypothesized that there would be no more significant differences between the clinical and radiological outcomes of these 2 treatments after 5 years of follow-up.
METHODS The current study reports the clinical and radiological results of an additional 5-year follow-up evaluation of a multicenter double-blinded RCT, with parallel groups and equal (1:1) simple randomization, of which the 1-year results were published previously in this journal.14 Materials and methods are reported in a concise format below. For more detailed information, please see the original study.14 All stages of the study were approved by the institutional medical ethics review board, and all participating patients signed an informed consent form.
Study Population The population for the current study consisted of all consecutive patients with shoulder complaints due to RCCT (.3 mm) who were included in the original trial (n = 48) between March 2010 and December 2011 (Figure 1). Addresses and data on patients’ death were verified using the hospital information system, which is linked to a municipal personal records database. We were able to contact all 48 patients and invited them for additional follow-up evaluations at the outpatient clinic or to fill out questionnaires as sent by mail.
Blinding and Intervention At baseline, all patients underwent a US evaluation by an experienced musculoskeletal radiologist to assess eligibility criteria, (partial) rotator cuff tears, and signs of tendinosis or bursitis. Next, participants were randomized for either US-guided barbotage in combination with a SAIC (group 1) or an isolated US-guided SAIC (group 2).
Figure 1. Study flowchart.
After sterile preparation, included patients received an anesthetic injection in the skin (lidocaine 1%). Next, a 21gauge needle was positioned in the subacromial bursa with US guidance, 1 to 2 cm caudolateral to the acromial tip. For the SAIC, 5 mL of bupivacaine (5 mg/mL; Actavis) and 1 mL of Depo-Medrol (40 mg/mL; Pfizer) were injected. In addition to the SAIC, in group 1, US-guided needling was performed with a 55-mm 18-gauge needle. The needle was introduced into the calcific deposit, which was then flushed using a syringe with saline solution (room temperature). After lavage, repeated perforation of the deposit was performed. Group 2 received only the SAIC. All patients and the coordinating investigator, who was absent during the entire intervention, were blinded for treatment. The postintervention treatment and follow-up protocol were identical in both groups: paracetamol (1000 mg, 4 times a day) combined with celecoxib (100 mg, 2 times a day) for 3 days. In patients with contraindications for celecoxib, 50 mg
*Address correspondence to Pieter Bas de Witte, MD, PhD, Department of Orthopaedics, Leiden University Medical Center, Postzone J11R, Postbus 9600, 2300 RC Leiden, the Netherlands (email: [email protected]). y Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands. z Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands. One or more of the authors has declared the following potential conflict of interest or source of funding: This study is part of a larger project funded by ZonMw, the Netherlands Organisation for Health Research and Development (grant No. 40-00703-98-8564), and the Dutch Arthritis Association (grant No. 09-1-303).
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tramadol was prescribed 3 times a day. Patients were instructed to use an icepack on the shoulder when experiencing pain in the days after the intervention. In case of persisting symptoms and no signs of resorption at 6 months or longer after the index procedure, patients underwent barbotage (ie, a second barbotage procedure in group 1 patients) or surgery, depending on the preference of the referring orthopaedic surgeon and the patient. The principal investigator and the patients remained blinded for the initial study intervention.
Follow-up All patients had regular follow-up visits with the coordinating investigator (P.B.d.W.) during the first year of follow-up, as described previously (6 weeks, 3 months, 6 months, and 1 year after the intervention).14 For the current study, patients underwent an additional 5-year follow-up evaluation between December 2015 and May 2016 with the same coordinating investigator or a colleague (A.K.) at the orthopaedics outpatient clinic. The clinical status was assessed at each follow-up moment with the Constant score (CS; primary outcome),13 the Disabilities of the Arm, Shoulder and Hand (DASH),18 and the Western Ontario Rotator Cuff Index (WORC).28 If patients could not come to the outpatient clinic, the WORC and DASH were sent by mail. Standard shoulder radiographs (anteroposterior view in internal and external rotation and axial view) were obtained immediately before the index procedure, at 1 year, at 5 years, and if necessary, on clinical indication. Calcific deposits were characterized using the Ga¨rtner classification as follows22: type I calcifications have a sharp border and a dense structure, type II calcifications either have a sharp border and inhomogeneous structure or a vague border and a homogeneous structure, and type III calcifications have a cloudy appearance with a vague border and a transparent structure. Affected tendons and the number of deposits were determined, and all deposits were measured for size (mm). In case of multiple calcifications, the characteristics of the largest baseline calcification were entered in the statistical analyses. For the current study, patients underwent an additional US evaluation at 5 years by an experienced musculoskeletal radiologist (M.R.), who was blinded for the initial study intervention, to assess the same parameters as at baseline14: bursitis (eg, effusion, hypervascularization, thickened bursa), tendinosis, and rotator cuff tear (partial or full thickness).
Statistical Analysis The original sample size calculation of this trial indicated that a group size of 40 participants was needed to find a clinically significant difference of 10.0 points in the CS, as reported in our previous publication.14 Data were expressed as means and SDs or medians and ranges where relevant. Correlations of baseline calcification characteristics (size, Ga¨rtner classification) and clinical baseline
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scores (CS, WORC, DASH) were assessed with Pearson correlation coefficients. Independent Student t tests were applied to compare final follow-up total CS scores and improvement (difference from baseline) scores between both groups. Improvement scores were also assessed, stratified for the baseline Ga¨rtner classification and treatment. Additionally, linear regression analysis was performed with the CS at final follow-up as a dependent variable, taking into account the treatment method, baseline CS, baseline Ga¨rtner classification, and interaction terms. Similar analyses were used for the WORC and DASH. Proportions of patients who underwent additional treatment (ie, barbotage or surgery) during the follow-up period for persisting symptoms and resorption rates (proportions of participants with either partial resorption [a decrease in Ga¨rtner classification and/or calcification size] or total resorption) were compared with Fisher exact tests. Linear regression analysis was performed to assess the effect of total versus partial/no resorption on the final primary outcome (CS), with the applied treatment method as a factor. A mixed model with a random effect for each patient (repeated measures) was used to evaluate postintervention clinical scores at all follow-up moments and associations with the treatment method, baseline Ga¨rtner classification, and baseline clinical scores. The CS, WORC, and DASH were each applied as a dependent variable. Follow-up moment, baseline clinical score, baseline Ga¨rtner classification, and the interaction terms between the treatment method and follow-up moment and baseline Ga¨rtner classification were applied as independent variables. Analyses were performed according to the intention-totreat principle. As a sensitivity analysis, we also applied a per-protocol analysis, with a similar approach and statistical models. SPSS Statistics 24.0 software (IBM) was used for statistical analyses, and P values \.05 were interpreted as statistically significant.
RESULTS Baseline Characteristics The baseline population was similar to the previous study, with 48 patients (25 female) and a mean age of 52.0 6 7.3 years. See Tables 1 and 2 for baseline demographics, clinical scores, and radiological characteristics. No clinically relevant or statistically significant associations were found between radiological characteristics and baseline clinical scores (data not shown), but there was a significant correlation between the calcification size and Ga¨rtner classification, with a Pearson correlation coefficient of –0.32 (P = .03); that is, calcifications with a higher Ga¨rtner classification were on average smaller in size. The baseline US evaluation showed signs of bursitis in 14 patients. Six patients had signs of rotator cuff tendinosis, and there were partial rotator cuff tears in 3 patients: 1 supraspinatus, 1 infraspinatus, and 1 combined supraspinatus and infraspinatus. There were no full-thickness rotator cuff tears.
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TABLE 1 Baseline Characteristicsa
Age, y Sex, male/female, n Body mass index, kg/m2 Affected side, right/left, n Dominant side affected, yes/no, n Baseline clinical scores WORC DASH Constant score VAS for rest VAS for activities of daily living
All Patients (N = 48)
Group 1: Barbotage and SAIC (n = 23)
Group 2: SAIC (n = 25)
52.0 6 7.3 23/25 25.7 6 3.3 35/13 31/17
53.7 6 7.3 11/12 27.0 6 3.2 16/7 15/8
50.4 6 7.2 12/13 24.7 6 3.0 19/6 16/9
45.8 36.9 68.7 40.0 49.2
50.3 32.7 71.6 33.4 42.5
41.6 40.7 66.0 46.0 55.3
6 6 6 6 6
19.7 17.3 11.9 24.3 21.5
6 6 6 6 6
20.1 17.6 12.2 23.2 23.6
6 6 6 6 6
18.7 16.4 11.2 24.2 17.7
a Data are presented as mean 6 SD unless otherwise specified. DASH, Disabilities of the Arm, Shoulder and Hand; SAIC, corticosteroid injection in the subacromial bursa; VAS, visual analog scale (score of 100 being severe pain); WORC, Western Ontario Rotator Cuff Index.
TABLE 2 Baseline Findings From Radiological Evaluationa All Patients (N = 48) No. of calcifications 1 2 .2 .1 tendon involved Affected tendon Supraspinatus Infraspinatus Subscapularis Teres minor Classification of calcificationb Ga¨rtner type I Ga¨rtner type II Ga¨rtner type III Size of calcification,b mean 6 SD, mm
Group 1: Barbotage and SAIC (n = 23)
Group 2: SAIC (n = 25)
30 15 3 7
(62.5) (31.3) (6.3) (14.6)
18 5 0 3
(78.3) (21.7) (0.0) (13.0)
12 10 3 4
(48.0) (40.0) (12.0) (16.0)
36 16 4 0
(75.0) (33.3) (8.3) (0.0)
17 7 1 0
(73.9) (30.4) (4.3) (0.0)
19 9 3 0
(76.0) (36.0) (12.0) (0.0)
20 (41.7) 22 (45.8) 6 (12.5) 14.2 6 5.5
11 (47.8) 9 (39.1) 3 (13.0) 14.5 6 4.7
9 (36.0) 13 (52.0) 3 (12.0) 13.9 6 6.1
a
Data are presented as n (%) unless otherwise specified. SAIC, corticosteroid injection in the subacromial bursa. Values are based on observations of the largest calcific deposit in each patient.
b
Follow-up, Complications, and Additional Treatment
Final Follow-up Evaluation
As reported in the previous publication, no patients were lost to follow-up in the first year. Between the 1-year and 5-year evaluation, 1 patient from group 2 refused to participate, and 4 patients only wanted to participate with questionnaires by mail (2 in group 1 and 2 in group 2). All others were evaluated at the outpatient clinic. Overall, there were no serious adverse events or complications. Two patients developed frozen shoulder syndrome after barbotage, but symptoms declined during the first year of follow-up. During the complete 5-year follow-up period, 20 patients underwent additional treatment (15 in the first year): 4 in group 1 (3 barbotage [ie, second barbotage procedure] and 1 surgery) and 16 in group 2 (13 barbotage and 3 surgery) (P \ .001). This was despite successful perforation in all 23 patients who were primarily treated with barbotage (group 1) and successful aspiration and/or fragmentation in 19 (82.6%).
After a mean follow-up of 5.1 6 0.5 years, the mean CS was 90 (95% CI, 83.0 to 95.9) in group 1 versus 87 (95% CI, 80.5 to 93.5) in group 2, leading to a mean difference of 3 (95% CI, –6.4 to 11.3) (P = .58). There was a statistically significant improvement in the CS of 18 (95% CI, 12.3 to 23.0) in group 1 and 21 (95% CI, 16.2 to 26.2) in group 2, with respect to baseline scores, leading to a mean difference of –4 (95% CI, –10.6 to 3.6) (P = .32). Similar results were observed for the total WORC and DASH scores and improvement in WORC and DASH scores, without statistically significant differences between the treatment groups (Table 3). Stratified for the baseline Ga¨rtner classification and treatment, results were best for patients with type I calcifications who were treated in group 2, as expressed in an improvement of the CS (mean difference between treatment groups: 13 [95% CI, –0.3 to 26.4]; P = .06). For any
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TABLE 3 Clinical Scores and Improvement at 5-Year Follow-upa
Constant score Total score Improvement WORC Total score Improvement DASH Total score Improvement
Group 1: Barbotage and SAIC
Group 2: SAIC
Difference
Mean (95% CI)
Mean (95% CI)
Mean (95% CI)
P Value
89.5 (83.0 to 95.9) 17.7 (12.3 to 23.0)
87.0 (80.5 to 93.5) 21.2 (16.2 to 26.2)
2.5 (–6.4 to 11.3) –3.5 (–10.6 to 3.6)
.58 .32
83.2 (71.9 to 94.4) 32.9 (23.9 to 41.8)
79.0 (68.0 to 89.9) 38.2 (28.1 to 48.4)
4.2 (–11.0 to 19.4) –5.4 (–18.6 to 7.8)
.58 .42
12.7 (3.5 to 21.8) –19.2 (–26.1 to –12.2)
18.0 (8.7 to 27.3) –23.5 (–31.4 to –15.5)
–5.3 (–18.0 to 7.3) 4.3 (–6.0 to 14.7)
.40 .40
a
Differences between groups were calculated with independent Student t tests. DASH, Disabilities of the Arm, Shoulder and Hand; SAIC, corticosteroid injection in the subacromial bursa; WORC, Western Ontario Rotator Cuff Index.
Figure 2. Improvement in the Constant score at 5 years of follow-up in both treatment groups, stratified for the baseline Ga¨rtner classification. of the other baseline calcification classifications, there were no statistically significant or clinically relevant differences in CS improvement scores between the treatment groups (Figure 2). With regression analysis, we assessed the treatment effect at final follow-up, taking into account baseline scores and the Ga¨rtner classification. There was a significant effect for the baseline CS, with an effect size of 0.8 (95% CI, 0.51-1.11): that is, a 10-point higher baseline score was associated with a mean additional 8 points at final follow-up. The mean treatment effect for barbotage was 2
(95% CI, –15.7 to 19.6; P = .83). There was a clinically relevant positive effect size for a baseline Ga¨rtner type I classification, with 15 (95% CI, –0.3 to 30.8; not significant) on the final CS. The interaction between treatment method and Ga¨rtner type I classification had an effect size of –14 (95% CI, –34.5 to 7.0) for barbotage. Hence, as with the stratified analyses, results appeared better for Ga¨rtner type I calcifications treated with a SAIC in our data (not significant), but there were no signs of significant effects for other Ga¨rtner classifications and interactions with the treatment method. Results were similar for the WORC and DASH: effect sizes of 0.8 (95% CI, 0.43-1.09) for the baseline WORC score and 0.8 (95% CI, 0.51-1.12) for the baseline DASH score, no significant effects for the treatment method, and positive (not significant) effects for a Ga¨rtner type I classification at baseline combined with a negative interaction term for barbotage and Ga¨rtner type I classification (not significant). With regard to the radiological outcomes, there was total resorption of all calcifications in 13 of 21 (62%) available patients in group 1 and 16 of 22 (73%) available patients in group 2 (P = .45). There was partial resorption in 7 patients in group 1 and 5 patients in group 2. The mean calcification size decreased by 13.2 mm in group 1 versus 13.5 mm in group 2 (P = .86). Overall, patients with total resorption at 5 years had a CS of 10 points higher (95% CI, 1.4-19.1), without a significant effect for the treatment method. The US evaluation at 5 years revealed 3 intrasubstance supraspinatus tears at former calcification sites (1 in group 1 and 2 in group 2), 1 pre-existing partial supraspinatus tear in group 2, 1 new partial subscapularis tear in group 1, and 1 new full-thickness combined supraspinatus/infraspinatus tear in group 2. Furthermore, we found signs of bursitis in 3 patients in group 1. In group 2, we found signs of bursitis in 3 patients, which was combined with rotator cuff tendinosis in 1. One patient in group 2 had tendinosis of the supraspinatus without other findings. We found no associations between these radiological outcomes and final clinical scores.
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Figure 3. Clinical course expressed in the (A) Constant score (CS), (B) Western Ontario Rotator Cuff Index (WORC), and (C) Disabilities of the Arm, Shoulder and Hand (DASH) after the treatment of calcific tendinitis of the rotator cuff with either barbotage and an ultrasound-guided corticosteroid injection in the subacromial bursa (SAIC; group 1) or an isolated ultrasound-guided SAIC (group 2).
Mixed Model (Repeated Measures of Complete Follow-up Period) The course of clinical scores in each treatment group is displayed in Figure 3. With mixed-model analysis, the mean effect for barbotage versus a SAIC on the CS was 6 (95% CI, –8.9 to 21.5). The baseline CS effect was 0.7 (95% CI, 0.49-0.95) for each additional pretreatment point. There was a significant effect for each follow-up moment on the CS (data not shown). The interaction between treatment
method and follow-up was significant for the 1-year followup moment in favor of barbotage: 11 (95% CI, 1.4-19.5). Hence, as demonstrated in Figure 3A, there were higher overall clinical scores for barbotage at 6 weeks, followed by lower scores at 3 months. From 6 months to 1 year, there were higher scores in group 1 compared with group 2. At 5 years, there were no more clinically relevant or statistically significant differences between the groups. Ga¨rtner classification and interaction with the treatment method had no significant effects. Estimated clinical outcomes expressed
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Figure 4. Estimated Constant scores (baseline, 6 weeks, 3 months, 6 months, 1 year, 5 years) of the averaged group of patients with calcific tendinitis of the rotator cuff, based on mixed-model analysis. in the CS for the averaged RCCT patient group based on the mixed model are displayed in Figure 4. For the WORC, similar results were found: the overall treatment effect was 19 (95% CI, –6.7 to 42.7) for barbotage versus a SAIC. The effect size of the baseline WORC score was 0.8 (95% CI, 0.55-0.99). Similar observations were found for the DASH, with only a significant effect for the baseline DASH score: 0.8 (95% CI, 0.64-1.00).
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Figure 5. Clinical course expressed in the Constant score with the per-protocol approach. In this analysis, only patients who did not undergo additional barbotage or surgery during the follow-up period were included, leaving 19 patients in group 1 (barbotage and ultrasound-guided corticosteroid injection in the subacromial bursa [SAIC]) and 8 patients in group 2 (ultrasound-guided SAIC). intention-to-treat approach. Differences between the groups were calculated with independent Student t tests (Table 4).
Per-Protocol Approach
DISCUSSION
Only patients who did not undergo additional barbotage or surgery during the follow-up period were included in a sensitivity analysis, leaving 19 patients in group 1 and 8 patients in group 2. t tests comparing total scores as well as improvement scores at the final evaluation showed no statistically significant differences between the treatment groups for the CS, DASH, and WORC. Overall, similar improvement was observed as in the intention-to-treat analysis (Table 4). The mean decrease in calcification size was 12.2 mm in group 1 and 11.9 mm in group 2 (mean difference, 0.4 mm [95% CI, –6.4 to 7.1]; P = .72). With linear regression analysis for the 5-year results, the effects for baseline scores were again significant for the CS (0.7; P = .002), WORC (0.8; P = .002), and DASH (0.8; P \ .001). There were no significant effects for the treatment method and baseline Ga¨rtner classification. For the complete follow-up (Figure 5), mixed-model analysis resulted in significant effects for baseline scores and additional significant effects for follow-up moments on clinical scores (data not shown), comparable with those of the
The results of this 5-year follow-up RCT showed that there are no statistically significant differences in the clinical and radiological midterm outcomes of US-guided barbotage combined with a SAIC (5 mL of bupivacaine [5 mg/mL] and 1 mL of Depo-Medrol [40 mg/mL]) compared with an isolated US-guided SAIC in patients with RCCT. There was a statistically significant and clinically relevant improvement in both groups in terms of clinical scores and radiological resorption rates compared with baseline. This is in contrast to our previous publication of the 1-year results of this RCT, showing significantly superior results for barbotage compared with a SAIC.14 The previous publication with 1-year results14 was the first RCT assessing barbotage for RCCT, and to our knowledge, as supported by a recent systematic review by Louwerens et al,31 there are no other RCTs on barbotage available with a follow-up period of more than 1 year. A positive long-term effect of barbotage can be more or less expected, based on our previous results and the literature. However, it might be surprising that we observed similar
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TABLE 4 Clinical Scores and Improvement at 5-Year Follow-up in Per-Protocol Analysisa
Constant score Total score Improvement WORC Total score Improvement DASH Total score Improvement
Group 1: Barbotage and SAIC
Group 2: SAIC
Difference
Mean (95% CI)
Mean (95% CI)
Mean (95% CI)
P Value
90.7 (84.2 to 97.1) 16.9 (11.0 to 22.9)
85.9 (69.0 to 102.7) 23.6 (9.9 to 37.3)
4.8 (–8.6 to 18.2) –6.6 (–18.3 to 5.1)
.47 .25
83.0 (69.9 to 96.1) 32.2 (21.5 to 42.9)
79.3 (55.6 to 103.0) 41.9 (18.0 to 65.8)
3.7 (–20.2 to 27.5) –9.7 (–30.7 to 11.3)
.75 .35
11.7 (1.5 to 21.9) –19.1 (–27.5 to –10.6)
19.5 (–1.2 to 40.2) –28.0 (–45.7 to –10.4)
–7.8 (–26.9 to 11.4) 9.0 (–7.1 to 25.0)
.41 .26
a
Only patients who did not undergo additional barbotage or surgery during the follow-up period were included in these analyses, leaving 19 patients in group 1 and 8 in group 2. DASH, Disabilities of the Arm, Shoulder and Hand; SAIC, corticosteroid injection in the subacromial bursa; WORC, Western Ontario Rotator Cuff Index.
and good clinical outcomes in group 2 after 5 years. This could be partly explained by US guidance of the SAIC, regular and frequent follow-up visits with the same doctor, and the natural (often self-limiting) course of RCCT.34,35 There could be confounding due to the relatively high number of patients in group 2 who underwent additional treatment after a minimum of 6 months of follow-up. Nevertheless, the per-protocol analysis showed similar results. Follow-up radiographs at 5 years showed full or partial resorption of calcific deposits in 95% of the patients (62% full resorption in group 1 and 73% in group 2). It has been described that the outcomes of barbotage are better with ill-defined calcifications (eg, Ga¨rtner type II or III classification) and that these types of calcifications can be resistant to more conservative treatments.21 However, others reported that type III calcifications actually have a higher possibility of spontaneous resorption.5,33 Also, where we found better 1-year outcomes of barbotage for patients with baseline Ga¨rtner type II or III calcifications in our previous study, there were no such associations in the current study with 5 years’ follow-up. Remarkably, we found better results for a SAIC in patients with a baseline Ga¨rtner type I calcification, but without statistical significance. Additionally, conclusions must be drawn with care for these subgroup analyses in a relatively small patient cohort, including participants who underwent additional treatment during the follow-up period. Lastly, it has been reported that patients with radiological improvement over time report better clinical results.29 Concordantly, in the current study, we found better results in patients with complete resorption, compared with patients with partial or no resorption, regardless of the applied treatment method. The US evaluation at 5 years revealed 3 intrasubstance rotator cuff tears at former calcification sites. Only 1 patient in group 2 (female, 47 years old at inclusion, additional barbotage after 1 year) developed a full-thickness combined supraspinatus and infraspinatus tendon tear during the follow-up period. Thus, calcific resorption and barbotage were not clearly associated with rotator cuff tendon disruption after 5 years. In both groups, there was
a relatively high prevalence of signs of bursitis (n = 6; combined with tendinosis in 1). However, these findings were not associated with inferior clinical outcomes. The literature on the long-term outcomes of barbotage as well as conservative treatments is limited and only available in retrospective and descriptive studies. However, the observed similar 5-year results of a SAIC and barbotage in this RCT are in concordance with the literature. In an observational study, Serafini et al34 reported superior results for barbotage in the first year and comparable good clinical outcomes for barbotage and more conservative treatment methods after 5 to 10 years. In another observational study, conducted by our group, similar long-term clinical results for barbotage and more conservative methods were found as well after a mean follow-up of 14 years.15 In this latter study, however, 42% of the respondents indicated persisting symptoms (long-term WORC score \60) in both treatment groups. Differences with respect to the good overall results of the current study might be caused by, for example, confounding by indication in the mentioned observational study, the standardized and intensive follow-up with a low dropout rate in this RCT, and differences in age and the duration of follow-up. Furthermore, it must be noted that there was no radiological evaluation of potential causes for persisting symptoms in the observational study (eg, rotator cuff tear, persisting/recurrent calcifications, alternative shoulder condition). Although a SAIC, with or without US guidance, is a frequently applied treatment for shoulder symptoms,25,30 we found no other studies assessing its midterm and longterm effectiveness, specifically in patients with RCCT. A SAIC is easy to perform, is low in cost, and has a low complication rate. It can be performed under US guidance for more accuracy, although clinical benefits compared with blind injections have not been objectified for subacromial pain syndrome.11 In the current RCT, patients in group 2 had statistically significant and clinically relevant improvement in the first 6 weeks, but symptoms recurred between 6 weeks and 6 months after treatment. After this period, there was a steadily overall improvement up
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to the level of clinical scores in group 1 at 5 years. However, after 6 months, a relatively high number of patients in group 2 underwent additional treatment, including barbotage. In group 1, a similar course was observed up to 3 months, but this was followed by faster further clinical improvement compared with group 2. The temporary recurrence of symptoms around 3 months has been reported earlier for barbotage.16 Possibly, there is short-term improvement, followed by recurring symptoms, due to a temporary effect of subacromial corticosteroids combined with resorptive-stage RCCT in the months after barbotage. Barbotage is slightly more invasive than a SAIC but is safe and generally well tolerated. It can be performed in the outpatient clinic under local anesthesia. There is much debate in the literature about single- or double-needle techniques, but there is no evidence for differences in outcomes.23,31 At the time of its introduction (around 1937), barbotage was performed under fluoroscopic guidance.12,32 Over the past decades, barbotage has increasingly been performed under US guidance. There is no radiation; the localization of calcifications is more accurate; and the rotator cuff, bursa, and biceps tendon and possible comorbidities in these structures can be visualized for differential diagnostic purposes.20 There are several alternatives for barbotage and a SAIC. In particular, extracorporeal shockwave therapy (ESWT) is the subject of numerous publications on RCCT. Yet again, there is a lack of studies with larger patient groups, longterm follow-ups, or prospective or comparative study designs. We found one trial comparing ESWT and barbotage in which Kim et al27 reported more effective pain relief and functional restoration for barbotage in the short term. In an observational study, Cho et al9 reported radiological success rates of 15% to 70% for ESWT, 28% to 76% for barbotage, and around 72% for surgery. Also, in a recent systematic review by Louwerens et al,31 it was concluded that good to excellent clinical outcomes can be achieved after high-energy ESWT but also after barbotage and arthroscopic surgery. More comparative studies with a long-term follow-up are needed to gain more information on the indications and differences in outcomes between ESWT and barbotage. On the basis of the current literature, both can be considered as a next step in the treatment of RCCT when more conservative methods are unsuccessful. A SAIC can also be considered, but more as an initial symptom treatment, guiding the natural course to improvement in the long term. Based on our results, barbotage is associated with faster improvement and a lower number of patients needing additional treatment compared with a SAIC. Surgery needs to be regarded as a last resort.9,26 Reported clinical results are good, but infections, rotator cuff tears, and other complications have been reported (5.8%-9.5%), and a longer hospital stay is needed.37 Limitations of the current study are similar to those in the previous publication.14 Twenty patients underwent additional barbotage or surgery during the complete follow-up period (16 in group 2 [P \ .001]), with 5 of them between 1 and 5 years. We accounted for this in the per-protocol analysis, but it is actually an important outcome of this study as well, indicating that patients treated with only SAIC are more likely to undergo additional treatment during follow-up. Furthermore, there is a bigger chance of patients having been unblinded
Barbotage vs Corticosteroids for RCCT
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during this longer follow-up period. However, the investigating researchers were blinded throughout the complete study. Lastly, a limitation reported in the previous publication was that the decline of symptoms and resolution of calcifications could take longer than 1 year, according to the literature and the results at the time. This limitation is not relevant anymore in the current study. In conclusion, this is the first double-blinded RCT comparing midterm clinical and radiological results of barbotage combined with a SAIC versus an isolated SAIC in patients with RCCT. Where clinical and radiological outcomes were significantly superior for barbotage after 1 year of follow-up, no more differences were found after 5 years. In case of persisting or severe symptoms and no signs of spontaneous resorption, barbotage and a SAIC might both lead to significant improvement in the long term, but based on our results, faster improvement can be expected with barbotage, with a lower chance of needing additional treatment during the follow-up period.
ACKNOWLEDGMENT The authors acknowledge the colleagues and secretaries of the Departments of Orthopaedics and Radiology at the Leiden University Medical Center for their help in the logistics and planning of the patients. REFERENCES 1. Aina R, Cardinal E, Bureau NJ, Aubin B, Brassard P. Calcific shoulder tendinitis: treatment with modified US-guided fine-needle technique. Radiology. 2001;221:455-461. 2. Albert JD, Meadeb J, Guggenbuhl P, et al. High-energy extracorporeal shock-wave therapy for calcifying tendinitis of the rotator cuff: a randomised trial. J Bone Joint Surg Br. 2007;89:335-341. 3. Ark JW, Flock TJ, Flatow EL, Bigliani LU. Arthroscopic treatment of calcific tendinitis of the shoulder. Arthroscopy. 1992;8:183-188. 4. Berg E. Calcific tendinitis of the shoulder. Orthop Nurs. 1997;16:68-69. 5. Bosworth DM. Calcium deposits in the shoulder and subacromial bursitis: a survey of 12,122 shoulders. JAMA. 1941;116:2477-2482. 6. Cacchio A, De BE, Desiati P, Spacca G, Santilli V, De PF. Effectiveness of treatment of calcific tendinitis of the shoulder by disodium EDTA. Arthritis Rheum. 2009;61:84-91. 7. Cacchio A, Paoloni M, Barile A, et al. Effectiveness of radial shockwave therapy for calcific tendinitis of the shoulder: single-blind, randomized clinical study. Phys Ther. 2006;86:672-682. 8. Chaudhry HJ. Ultrasound therapy for calcific tendinitis of the shoulder. N Engl J Med. 1999;341:1237. 9. Cho NS, Lee BG, Rhee YG. Radiologic course of the calcific deposits in calcific tendinitis of the shoulder: does the initial radiologic aspect affect the final results? J Shoulder Elbow Surg. 2010;19:267-272. 10. Ciccone CD. Does acetic acid iontophoresis accelerate the resorption of calcium deposits in calcific tendinitis of the shoulder? Phys Ther. 2003;83:68-74. 11. Cole BF, Peters KS, Hackett L, Murrell GA. Ultrasound-guided versus blind subacromial corticosteroid injections for subacromial impingement syndrome: a randomized, double-blind clinical trial. Am J Sports Med. 2016;44:702-707. 12. Comfort TH, Arafiles RP. Barbotage of the shoulder with imageintensified fluoroscopic control of needle placement for calcific tendinitis. Clin Orthop Relat Res. 1978;135:171-178. 13. Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987;214:160-164.
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