578293
research-article2015
CRE0010.1177/0269215515578293Clinical RehabilitationGarcía et al.
CLINICAL REHABILITATION
Article
Clinical Rehabilitation 1–12 © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215515578293 cre.sagepub.com
Comparative effectiveness of ultrasonophoresis and iontophoresis in impingement syndrome: A double-blind, randomized, placebo controlled trial Isabel García1, Cristina Lobo2, Esther López3, Jose Luis Serván3 and Jose María Tenías4
Abstract Objective: To estimate the effectiveness of ultrasonophoresis and iontophoresis with sodium diclofenac used in addition to an exercise program for patients with impingement syndrome. Design: Multicentre, double-blind, placebo randomized controlled trial. Setting: “Mancha Centro” Outpatient primary care clinic (Spain). Participants: A total of 175 patients were considered, of whom 88 met criteria and agreed. Intervention: The patients were randomly assigned to one of three groups: a) standard treatment (supervised exercises and cryotherapy) along with placebo iontophoresis and placebo ultrasonophoresis; b) standard treatment, iontophoresis, and placebo ultrasonophoresis; and c) standard treatment, ultrasonophoresis, and placebo iontophoresis. All patients received 15 treatment sessions. Outcome measures: Baseline, 6-, and 12-week evaluations were carried out. Functionality, pain, range of motion, strength and quality of life were assessed with the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), Constant-Murley score, and SF-36 scale. Results: Ultrasonophoresis group experienced significant decreases in pain compared to the standard treatment group (12.7 and 13.5 points in “bodily pain” dimension of SF-36; and 1,5 and 2,2 points in “pain” dimension of Constant Murley after 6 and 12 weeks of therapy, respectively). They also reported improved range of motion compared to the exercises group (2,1 points in Constant-Murley after 6 weeks and 12 weeks), better vitality and overall health (SF-36 dimensions). Iontophoresis, however, led to no significant improvements when added to the standard treatment. Conclusion: In patients with impingement syndrome, a combination of ultrasonophoresis and an exercise program are better than a combination of iontophoresis and the same exercise program or the exercise program alone. 1Healthcare
Centre Tomelloso I and Healthcare centre Madridejos (La Mancha Centro), Spain 2Healthcare Centre Argamasilla de Alba (La Mancha Centro), Spain 3Healthcare Centre Alcázar II (La Mancha Centro), Spain
4Research
Support Unit (La Mancha Centro), Spain
Corresponding author: Isabel García, Physiotherapy Unit, National Paraplegic Hospital of Toledo, Finca de la Peraleda, s/n, Toledo, 45071, Spain. Email: [email protected]
2
Clinical Rehabilitation
Keywords Impingement syndrome, iontophoresis, ultrasonophoresis, shoulder pain, phonophoresis Received: 27 July 2014; accepted: 28 February 2015
Introduction Shoulder pain is the third most commonly cited reason for going to a primary care doctor,1 with shoulder impingement syndrome being the most common shoulder complaint in individuals attending orthopedic and physical therapy clinics (44– 65%).2The first to describe this syndrome was Neer, who defined it as an irritation of the tendons that form the rotator cuff as it passes through the coracoacromial arch, with concomitant synovial inflammation of the shoulder bursa.3 The main symptom of impingement syndrome is pain, which is present in 40-50% of affected patients and can persist for up to one year after the first doctor’s visit in 50% of cases.4 In the majority of cases, the pain is not resolved by the mere prescription of oral pain medicines nor with moderate rest. As such, this syndrome not only constitutes a significant burden on health care resources, but also leads to losses in productivity due to work absenteeism.5,6 Physiotherapy management of impingement syndrome can include multiple interventions, eg exercise, electrotherapy, manual joint mobilizations, acupuncture, advice and education. The selection of treatments is often subjective and dependent on the skill and training of the therapist rather than on any rigorous evaluation of best evidence.7 At present there are few high quality studies that demonstrate the effectiveness of many of these techniques. However, exercises are one of the few physiotherapy techniques used in impingement syndrome which have been proven effective in high-quality clinical trials, displaying statistically significant benefits with regard to pain and function appear to involve multiple types of exercises, such as scapular stability exercises, strengthening of the rotator cuff through range, and flexibility exercises for the anterior and posterior shoulder.7
In Spanish primary care (PC), the setting within which this study was conducted, two of the most commonly used electrotherapy techniques for treating this condition are iontophoresis and ultrasonophoresis. We thus conducted a bibliographic search in four major databases (MEDLINE Pubmed Central, Physiotherapy evidence database-PEDro, Cochrane database System review, and meta register of controlled trials-mRCT) for clinical trials analyzing the application of these techniques to impingement syndrome, identifying a total of 96 articles. Of these, we excluded papers that were not actually clinical trials or which dealt with calcifications and/or tendon ruptures. In the end, only three articles met these inclusion/exclusion criteria.8–10 Taskaynatan et al.8 published that application of steroid iontophoresis to the conventional physical therapy for patients with biceps tendinitis seems to provide a better and more prolongated clinical and functional improvement. Klaiman et al.9 concluded that ultrasound results in decreased pain an increased pressure tolerance in soft tissue injuries (epicondylitis, tendinitis, and tenosynovitis), and the addition of phonophoresis with fluocinonide does not augment the benefits of ultrasound used alone. Penderghest et al.,10 examined the efficacy of phonophoresis with dexamethasonelidocaine compared to ultrasound without the use of drugs on perceived pain associated with syntomathic tendinitis (shoulder, biceps, triceps and knee), and the results showed no significant differences between the treatment modalities. However, after conducting this search, not only did it become evident that the number of studies published on this topic is extremely low, but also that they are of low methodological quality, with small sample sizes and heterogeneous study population, showing inconsistent results.11 Therefore a great need exists for
3
García et al. clinical trials of adequate methodological quality in order to draw up better treatment protocols based effective techniques. Not only would this ensure faster patient recovery, but it is also likely to result in cost savings for healthcare institutions. The aim of the present study was to assess the effectiveness of ultrasonophoresis and iontophoresis as treatments for impingement syndrome with respect to pain, function and quality of life.
Method This was a multicentre, double blind, randomized, placebo controlled trial comparing three groups of treatments. Patients were recruited to the study between December 2010 and November 2012; all patients had received a diagnosis of impingement syndrome and belonged to the primary care area of “La Mancha Centro” in central Spain (three of the eleven healthcare centre of the primary care area participated in the study: Madridejos Healthcare centre, Alcázar de San Juan Healthcare centre and Argamasilla Healthcare centre). Human experimentation was approved by the La Mancha Centro Ethics Committee. Patients with suspected impingement syndrome were evaluated by a physical medicine specialist, who then determined whether a given patient met the inclusion and exclusion criteria. If the inclusion/exclusion criteria were met, the patient was given an informed consent form to fill out in order to participate in the study. The inclusion criteria were as follows: positive Neer impingement sign;12 positive HawkinsKennedy impingement sign;13 painful arc between 60º and 120º during active abduction;14 pain upon palpation of several of the osteotendinous junctions of infraspinatus, supraspinatus, subscapularis, and teres minor; pain during any of the isometric contractions on abduction (first 10º); internal rotation (anatomical position and at an elbow flexion of 90º); external rotation (anatomical position and at an elbow flexion of 90º); and shoulder flexion. The exclusion criteria were as follows: signs of complete rotator cuff tear (painful arc sign,14 droparm sign,15 and infraspinatus muscle test);16 tendon
calcification (detected by X-rays); signs of acute inflammation; radicular signs (in cervical radiculopathy, the distribution of the upper extremity signs and symptoms correspond to a specific nerve root, with characteristic reflex, motor, and sensory loss); glenohumeral instability (appehension and relocation tests);17 prior surgery; having had an injection of steroid in the three months prior to physiotherapy; limited passive joint balance; bilateral involvement; refusal to participate in the study; lack of physical and/or psychological independence; contraindications specific to the use of ultrasound (pregnancy, application to lung or heart area, and patients with coagulation pathologies, infectious or hemorrhagic diseases, tumors, or neoclassical tumor processes); contraindications specific to the use of galvanic current (application to tumor sites, recent bleeding, metal or osteosynthetic material implants, and patients with pacemakers, heart problems, poor skin condition/wounds, and a loss of sensation in the area to be treated); and contraindications specific to the drug. We calculated that a minimum of 25 patients per treatment group was required. The sample size was estimated for detect a change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire of 30 points of improvements, with a beta error of 20% and a significant level of 95%.
Outcome measures The primary outcome was the DASH outcome measure,18 that is a 30-points questionnaire that looks the ability of a patient to perform certain upper extremity activities (included as supplementary material Appendix 1). The score ranges from 0 (no disability) to 100 (most severe disability). The secondary outcomes were the ConstantMurley score and the Short Form (SF-36) Health Survey scale. The Constant-Murley score19,20 is a 100-points scale divided into four subscales: pain (15 points) activities of daily living (20 points), range of movement with a goniometer (40 points) and strength with a dynamometer (25 points). The higher the score, the higher the quality of the function. Although it was approved by the executive committee of the European Society for Surgery of the Shoulder and
4 Elbow in 1989, it has yet to be validated for use in Spanish21 (included as supplementary material Appendix 2). The Short Form (SF-36) Health Survey scale,22 to assess patient satisfaction/quality of life, consists of 36 items that evaluate positive and negative health aspects covering the following categories: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each category is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. Both the DASH questionnaire and the SF-36 scale have been evaluated and validated in our environment by Spanish researchers23–25 showing adequate psychometric propierties to be applied to our patients. The Constant-Murley score unfortunately has not been validated in our country but its psychometric properties, together with those of other scales such as the DASH questionnaire has been recently reviewed.26 The DASH questionnaire and SF-36 scale, both of which are self-administered, were given to the study subjects at the first physical therapy evaluation and again 6 and 12 weeks after beginning treatment. The Constant-Murley score was administered by a physiotherapist not involved in patient treatment. Before beginning the study, all physiotherapists participating in the assessments were trained in the administration of this score to guarantee good interobserver validity. Active mobility was assessed with a goniometer, and in all cases, the patient was sitting with back support to avoid compensations. Muscle strength was evaluated with a dynamometer with the patient in supine position. The patient was asked to perform a static five seconds abduction contraction (with the shoulder at a 90º abduction angle, or the maximum abduction tolerated by the patient), with the elbow extended and the forearm in neutral pronosupination (Figure 1). The result was expressed as the average of three attempts. The score was administered in the first assessment and then repeated after 6 and 12 weeks.
Random allocation In order to randomize the assignment of patients to treatment groups and blind both patients and
Clinical Rehabilitation
Figure 1. Strength. Constant-Murley score.
researchers to the randomization sequence, we used permuted block randomization to generate groups of various sizes (six and nine assignments each to avoid any type of learning phenomenon) until a suitable sequence was created with up to 120 randomized numbers. The sequence was generated and blinded by individuals not involved in the assignment of the treatment groups, introducing each assignment into sequentially numbered, opaque envelopes which remained unopened until after obtaining informed consent and carrying out the first evaluation.
Intervention Before the envelope with the patient’s group assignment was opened, each patient was given an initial physical therapy evaluation by a trained physiotherapist. After assessing each patient, the physiotherapist of the corresponding health clinic administered treatment according to the guidelines of the patient’s assigned group. All patients received 15 daily sessions from Monday to Friday of one of the following regimens: The control group received treatment consisting of the application of an ultrasonophoresis placebo, an iontophoresis placebo, and a standard set of supervised exercises followed by 10 minutes of cryotherapy. The iontophoresis group underwent an ultrasonophoresis placebo, iontophoresis treatment, and a standard set of supervised exercises followed by 10 minutes of cryotherapy.
5
García et al. The ultrasonophoresis group received ultrasonophoresis treatment, an iontophoresis placebo, and a standard set of supervised exercises followed by 10 minutes of cryotherapy.
Intervention variables Iontophoresis: 5x5 electrodes with an intensity of 0.1-0.2 mA/cm2 were applied for 10 minutes. The topical application used was sodium diclofenac (75 mg vials of diclofenac), administered under the active electrode (cathode). The placement alternated: one day, the active electrode was placed on the insertion site of the supraspinatus tendon with the non-active electrode placed on the infraspinatus insertion. The next day, the electrodes were placed on the opposite insertion sites. Ultrasonophoresis: The effective radiation area (ERA) in our study was 5 cm2, at 1 MHz, continuous mode (100%), and 0.7 W/cm2, with a treated area four times the ERA and with a bearn nonuniformity radio (BNR) less than 5. The treatment lasted for five minutes (three minutes in the insertion of the supraspinatus and two minutes in the infraspinatus insertion). Sodium diclofenac gel was used as the topical medium. The basis of treatment consisted of supervised physical exercises (supplementary material Appendix 3), followed by cryotherapy (application of a cold pack) for 10 minutes. We decided to use supervised exercises as the basis of treatment in all groups as they constitute one of the few physiotherapy techniques used in impingement syndrome which have been proven effective in high-quality clinical trials.7 In this manner, each patient was guaranteed a treatment with proven effectiveness. The exercise protocol was elaborated based on the systematic review written by Kuhn27 in 2009, in which it was postulated that exercise produces both clinically and statistically significant pain reduction and improved shoulder function, and stated that this evidence-based protocol can be used by clinicians treating impingement syndrome and can serve as a gold standard to reduce variables in future cohort and comparative studies to help find better treatments for patients with this disorder.27 The administration of the placebos versus treatment was carried out as follows:
In the case of ultrasonophoresis, first a non-steroidal anti-inflammatory drug gel was applied to the head of the device, which was then applied without pressure to the patient, who was positioned with his/ her back to the machine. For the groups receiving placebo ultrasonophoresis, the non-steroidal antiinflammatory drug gel was also applied to the head of the device, we simulated turning the machine on (although it remained off throughout the procedure) and then set the timer for 5 minutes. When the time had elapsed, we simulated turning off the machine manually. For the group that received ultrasonophoresis treatment, treatment was administered normally, but the timer was set for over 5 minutes so that no sound was emitted when the machine was turned off manually after 5 minutes. The administration of iontophoresis was carried out by first placing a gauze with a non-steroidal antiinflammatory drug gel onto the spontex of the active electrode. The patient was placed with his/her back to the machine, which was kept covered so the patient couldn’t see it. The administration of the placebo was performed by placing a gauze with a non-steroidal anti-inflammatory drug gel onto the spandex of the active electrode and activating the channel that was not applied to the patient (the apparatus is equipped with 2 separate channels) so that the channel being applied transmitted no active current, but the timer still sounded after 10 minutes had elapsed. For iontophoresis treatment, the channel applied to the patient was activated.
Data analysis Results are presented as the mean ± standard deviation (quantitative indicators) and as absolute and relative frequencies (percentages) in the case of qualitative indicators. The effect of each treatment – ultrasonophoresis or iontophoresis – together with the exercises was expressed as the change observed at 6 and 12 weeks with respect to the baseline, calculated with the aid of an analysis of covariance (ANCOVA). In the ANCOVA models, baseline levels were included as covariates. Assumptions for parametric tests like the ANCOVA were checked (linearity, homocedasticity, and normality of residuals). All calculations were
6
Clinical Rehabilitation
Figure 2. CONSORT flow diagram.
controlled for age, sex, and dominance of the affected limb. We used an alpha value of 0.05 to establish statistically significant differences. The group to which each patient was assigned was maintained in the analysis regardless of the treatment finally received (intention to treat analysis). Random allocation was preserved and an intention to treat analysis was conducted. All calculations were performed with the IBM SPSS statistics package, version 19.
Results A total of 175 subjects were given information of whom 88 agreed and also met the inclusion/exclusion criteria and were randomized, 10 of whom discontinued treatment after receiving at least one therapeutic session and before the end of the 15th session or before completing the 12-week assessment. Therefore 78 subjects were analyzed.
See CONSORT flow diagram (Figure 2). Table 1 gives a description of each group with regard to sex, age, affected limb, and duration of disease. There was a slight predominance of women, with a mean age near to 60 years. In over half the cases the duration of disease was more than 6 months before starting recruitment. No relevant or significant differences were observed between groups for any of these variables. In relation to the questionnaire DASH we did not observe neither relevant nor statistically significant changes in relation to the type of therapy received. Both at 6 and 12 weeks no significant changes are observed in patients with ultrasonophoresis or iontophoresis compared to those who received only exercises (Tables 2 and 3). For the Constant-Murley score we observed a significant improvement associated to ultrasonophoresis at 6 and 12 weeks. This change was mainly due to the improvement of the “range of movement”
7
García et al. Table 1. Characteristics of treatment group subjects. Variable Sex Male Female Mean age ± SD Affected limb Not dominant Dominant Duration of disease < 6 weeks 6 wks. – 3 months 3 – 6 months > 6 months
Exercise (n=29)
Ultrasonophoresis (n=27)
Iontophoresis (n=22)
10 (34.5%) 19 (65.5%) 56.9 ± 12.3
12 (44.4%) 15 (55.6%) 61.9 ± 13.0
9 (40.9%) 13 (59.1%) 57.7 ± 17.3
7 (24.1%) 22 (75.9%)
11 (40.7%) 16 (59.3%)
11 (50%) 11 (50%)
1 (3.4%) 11 (37.9%) – 17 (58.6%)
3 (11.1%) 8 (29.6%)
1 (4.5%) 8 (36.4%)
– 16 (59.3%)
– 13 (59.1%)
dimension and to a lesser extent to the improvement of pain, mainly at twelve weeks. The SF-36 dimensions of physical role and bodily pain were the most affected. However, the baseline values for the assessment scales used were not statistically different among the three groups (Table 2). The values of the scales at 6 and 12 weeks are also given in Table 2 and Table 3 respectively. In general, higher values were observed in the ultrasonophoresis group. With respect to the baseline levels and in comparison to the exercise group, the levels for the ultrasonophoresis and iontophoresis groups at 6 and 12 weeks point to significant differences in favor of ultrasonophoresis. These differences remain after adjusting for age, sex, and affected limb dominance. Thus, patients who underwent ultrasonophoresis experienced relevant and significant improvements in their levels of bodily pain (SF-36. 12.7 and 13.5 points after 6 and 12 weeks of therapy, respectively). The Constant-Murley score increased to 4.9 points after 6 weeks and to 6.4 points, after to 12 weeks; and vitality, dimension of the SF36 scale, reached 9.5 points in 12 weeks. Mental health (SF-36) also showed a marked improvement (8.9 points) after 12 weeks, in the ultrasonophoresis group. However, in the group of iontophoresis, neither statistically, nor clinically relevant significant differences were observed. Residuals of the models did not deviate significantly from normality (Kolmogorov test) and showed no significant heterocedasticity (assessed by graphical methods).
Discussion Our study shows that adding ultrasonophoresis to a program of supervised exercises may lead to significant improvements in patients with impingement syndrome as compared to patients undergoing the exercise program alone. Subjects in the ultrasonophoresis group experienced significant decreases in pain compared to the standard treatment group (12.7 and 13.5 points in “bodily pain” dimension of SF-36 scale; and 1.5 and 2.2 points in “pain” dimension of Constant-Murley score after 6 and 12 weeks of therapy, respectively). They also reported an improved range of motion compared to the exercises group (2.1 points after 6 weeks and 12 weeks in “range of movement” dimension of Constant-Murley score). With respect to the ability of a patient to perform certain upper extremity activities (assessed with DASH questionnaire and “activities of daily living” dimension of Constant-Murley score), we did not observe either or relevant nor statistically significant changes in relation to the type of therapy received. All patients group improved strength after treatment, and the values for the assessment of the different scales were not statistically different among the three groups; however higher strength values were observed in the ultrasonophoresis group compared to the exercises group (1.6 points in “strength” dimension of Constant-Murley score). Mental health and vitality (SF-36 dimensions) also showed a marked improvement in the ultrasonophoresis group compared to the standard treatment (8.9 points and
53.7 (15.1) 51.4 (13.9) 4.5 (3.4) 12.6 (3.8) 27.6 (6.7) 6.9 (4.4) 64.1 (28.1) 41.1 (42.6) 54.1 (19.2) 58.3 (21.0) 56.7 (22.6) 76.4 (28.9) 66.7 (45.3) 66.1 (23.1)
DASH Constant Murley Pain Activities of day living Range of movement Strength SF36–Physical functioning SF36–Role-Physical SF36–Bodily Pain SF36–General Health SF36–Vitality SF36–Social Functioning SF36–Role-Emotional SF36–Mental Health
51.8 (13.6) 50.8 (12.8) 2.8 (3.2) 12.4 (3.8) 28.6 (6.3) 7.5 (3.9) 66.9 (21.9) 43.5 (43.1) 48.3 (19.4) 54.1 (18.0) 53.5 (19.4) 77.3 (23.5) 74.1 (40.6) 67.4 (22.8)
US group 55.8 (15.7) 47.9 (8.4) 3.9 (3.4) 12.0 (3.5) 26.0 (5.0) 6.1 (3.1) 63.4 (24.8) 48.9 (42.6) 51.5 (28.1) 54.8 (22.1) 53.4 (24.9) 72.0 (30.1) 68.2 (41.8) 62.7 (26.1)
IP group −9.6 17.4 3.1 4.6 6.4 3.2 4.4 20.9 4.6 1.8 0.7 7.4 2.1 3.0
Exercises group −9.3 21.1 5.6 5.6 7.3 2.4 5.3 15.2 16.0 –0.1 4.1 4.5 1.9 –0.6
US group −3.6 14.9 4.1 4.6 4.6 1.9 –0.1 4.7 5.2 –0.7 4.5 3.0 1.6 7.0
IP group
Change from baseline at 6 weeks
−1.9 (–7.2 to 3.3) 4.9 (0.2 to 9.6)* 1.5 (–0.5 to 3.5) 0.7 (–0.5 to 2.0) 2.1 (–0.04 to 4.2) −0.1 (–1.7 to 1.5) 1.2 (–6.3 to 8.6) −4.2 (–27.3 to 19.0) 12.7 (2.8 to 22.6)* –4.5 (–11.4 to 2.3) 5.4 (–2.2 to 13.1) –0.3 (–10.9 to 10.2) 6.7 (–12.5 to 25.9) 0.6 (–6.7 to 7.9)
Advantage for US group (95% CI)
US: Ultrasonophoresis, IP: Iontophoresis. Advantage (95% Confidence Interval) in relation to exercises group (reference) adjusted for age, sex, dominant limb affected. *P
research-article2015
CRE0010.1177/0269215515578293Clinical RehabilitationGarcía et al.
CLINICAL REHABILITATION
Article
Clinical Rehabilitation 1–12 © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215515578293 cre.sagepub.com
Comparative effectiveness of ultrasonophoresis and iontophoresis in impingement syndrome: A double-blind, randomized, placebo controlled trial Isabel García1, Cristina Lobo2, Esther López3, Jose Luis Serván3 and Jose María Tenías4
Abstract Objective: To estimate the effectiveness of ultrasonophoresis and iontophoresis with sodium diclofenac used in addition to an exercise program for patients with impingement syndrome. Design: Multicentre, double-blind, placebo randomized controlled trial. Setting: “Mancha Centro” Outpatient primary care clinic (Spain). Participants: A total of 175 patients were considered, of whom 88 met criteria and agreed. Intervention: The patients were randomly assigned to one of three groups: a) standard treatment (supervised exercises and cryotherapy) along with placebo iontophoresis and placebo ultrasonophoresis; b) standard treatment, iontophoresis, and placebo ultrasonophoresis; and c) standard treatment, ultrasonophoresis, and placebo iontophoresis. All patients received 15 treatment sessions. Outcome measures: Baseline, 6-, and 12-week evaluations were carried out. Functionality, pain, range of motion, strength and quality of life were assessed with the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), Constant-Murley score, and SF-36 scale. Results: Ultrasonophoresis group experienced significant decreases in pain compared to the standard treatment group (12.7 and 13.5 points in “bodily pain” dimension of SF-36; and 1,5 and 2,2 points in “pain” dimension of Constant Murley after 6 and 12 weeks of therapy, respectively). They also reported improved range of motion compared to the exercises group (2,1 points in Constant-Murley after 6 weeks and 12 weeks), better vitality and overall health (SF-36 dimensions). Iontophoresis, however, led to no significant improvements when added to the standard treatment. Conclusion: In patients with impingement syndrome, a combination of ultrasonophoresis and an exercise program are better than a combination of iontophoresis and the same exercise program or the exercise program alone. 1Healthcare
Centre Tomelloso I and Healthcare centre Madridejos (La Mancha Centro), Spain 2Healthcare Centre Argamasilla de Alba (La Mancha Centro), Spain 3Healthcare Centre Alcázar II (La Mancha Centro), Spain
4Research
Support Unit (La Mancha Centro), Spain
Corresponding author: Isabel García, Physiotherapy Unit, National Paraplegic Hospital of Toledo, Finca de la Peraleda, s/n, Toledo, 45071, Spain. Email: [email protected]
2
Clinical Rehabilitation
Keywords Impingement syndrome, iontophoresis, ultrasonophoresis, shoulder pain, phonophoresis Received: 27 July 2014; accepted: 28 February 2015
Introduction Shoulder pain is the third most commonly cited reason for going to a primary care doctor,1 with shoulder impingement syndrome being the most common shoulder complaint in individuals attending orthopedic and physical therapy clinics (44– 65%).2The first to describe this syndrome was Neer, who defined it as an irritation of the tendons that form the rotator cuff as it passes through the coracoacromial arch, with concomitant synovial inflammation of the shoulder bursa.3 The main symptom of impingement syndrome is pain, which is present in 40-50% of affected patients and can persist for up to one year after the first doctor’s visit in 50% of cases.4 In the majority of cases, the pain is not resolved by the mere prescription of oral pain medicines nor with moderate rest. As such, this syndrome not only constitutes a significant burden on health care resources, but also leads to losses in productivity due to work absenteeism.5,6 Physiotherapy management of impingement syndrome can include multiple interventions, eg exercise, electrotherapy, manual joint mobilizations, acupuncture, advice and education. The selection of treatments is often subjective and dependent on the skill and training of the therapist rather than on any rigorous evaluation of best evidence.7 At present there are few high quality studies that demonstrate the effectiveness of many of these techniques. However, exercises are one of the few physiotherapy techniques used in impingement syndrome which have been proven effective in high-quality clinical trials, displaying statistically significant benefits with regard to pain and function appear to involve multiple types of exercises, such as scapular stability exercises, strengthening of the rotator cuff through range, and flexibility exercises for the anterior and posterior shoulder.7
In Spanish primary care (PC), the setting within which this study was conducted, two of the most commonly used electrotherapy techniques for treating this condition are iontophoresis and ultrasonophoresis. We thus conducted a bibliographic search in four major databases (MEDLINE Pubmed Central, Physiotherapy evidence database-PEDro, Cochrane database System review, and meta register of controlled trials-mRCT) for clinical trials analyzing the application of these techniques to impingement syndrome, identifying a total of 96 articles. Of these, we excluded papers that were not actually clinical trials or which dealt with calcifications and/or tendon ruptures. In the end, only three articles met these inclusion/exclusion criteria.8–10 Taskaynatan et al.8 published that application of steroid iontophoresis to the conventional physical therapy for patients with biceps tendinitis seems to provide a better and more prolongated clinical and functional improvement. Klaiman et al.9 concluded that ultrasound results in decreased pain an increased pressure tolerance in soft tissue injuries (epicondylitis, tendinitis, and tenosynovitis), and the addition of phonophoresis with fluocinonide does not augment the benefits of ultrasound used alone. Penderghest et al.,10 examined the efficacy of phonophoresis with dexamethasonelidocaine compared to ultrasound without the use of drugs on perceived pain associated with syntomathic tendinitis (shoulder, biceps, triceps and knee), and the results showed no significant differences between the treatment modalities. However, after conducting this search, not only did it become evident that the number of studies published on this topic is extremely low, but also that they are of low methodological quality, with small sample sizes and heterogeneous study population, showing inconsistent results.11 Therefore a great need exists for
3
García et al. clinical trials of adequate methodological quality in order to draw up better treatment protocols based effective techniques. Not only would this ensure faster patient recovery, but it is also likely to result in cost savings for healthcare institutions. The aim of the present study was to assess the effectiveness of ultrasonophoresis and iontophoresis as treatments for impingement syndrome with respect to pain, function and quality of life.
Method This was a multicentre, double blind, randomized, placebo controlled trial comparing three groups of treatments. Patients were recruited to the study between December 2010 and November 2012; all patients had received a diagnosis of impingement syndrome and belonged to the primary care area of “La Mancha Centro” in central Spain (three of the eleven healthcare centre of the primary care area participated in the study: Madridejos Healthcare centre, Alcázar de San Juan Healthcare centre and Argamasilla Healthcare centre). Human experimentation was approved by the La Mancha Centro Ethics Committee. Patients with suspected impingement syndrome were evaluated by a physical medicine specialist, who then determined whether a given patient met the inclusion and exclusion criteria. If the inclusion/exclusion criteria were met, the patient was given an informed consent form to fill out in order to participate in the study. The inclusion criteria were as follows: positive Neer impingement sign;12 positive HawkinsKennedy impingement sign;13 painful arc between 60º and 120º during active abduction;14 pain upon palpation of several of the osteotendinous junctions of infraspinatus, supraspinatus, subscapularis, and teres minor; pain during any of the isometric contractions on abduction (first 10º); internal rotation (anatomical position and at an elbow flexion of 90º); external rotation (anatomical position and at an elbow flexion of 90º); and shoulder flexion. The exclusion criteria were as follows: signs of complete rotator cuff tear (painful arc sign,14 droparm sign,15 and infraspinatus muscle test);16 tendon
calcification (detected by X-rays); signs of acute inflammation; radicular signs (in cervical radiculopathy, the distribution of the upper extremity signs and symptoms correspond to a specific nerve root, with characteristic reflex, motor, and sensory loss); glenohumeral instability (appehension and relocation tests);17 prior surgery; having had an injection of steroid in the three months prior to physiotherapy; limited passive joint balance; bilateral involvement; refusal to participate in the study; lack of physical and/or psychological independence; contraindications specific to the use of ultrasound (pregnancy, application to lung or heart area, and patients with coagulation pathologies, infectious or hemorrhagic diseases, tumors, or neoclassical tumor processes); contraindications specific to the use of galvanic current (application to tumor sites, recent bleeding, metal or osteosynthetic material implants, and patients with pacemakers, heart problems, poor skin condition/wounds, and a loss of sensation in the area to be treated); and contraindications specific to the drug. We calculated that a minimum of 25 patients per treatment group was required. The sample size was estimated for detect a change in Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire of 30 points of improvements, with a beta error of 20% and a significant level of 95%.
Outcome measures The primary outcome was the DASH outcome measure,18 that is a 30-points questionnaire that looks the ability of a patient to perform certain upper extremity activities (included as supplementary material Appendix 1). The score ranges from 0 (no disability) to 100 (most severe disability). The secondary outcomes were the ConstantMurley score and the Short Form (SF-36) Health Survey scale. The Constant-Murley score19,20 is a 100-points scale divided into four subscales: pain (15 points) activities of daily living (20 points), range of movement with a goniometer (40 points) and strength with a dynamometer (25 points). The higher the score, the higher the quality of the function. Although it was approved by the executive committee of the European Society for Surgery of the Shoulder and
4 Elbow in 1989, it has yet to be validated for use in Spanish21 (included as supplementary material Appendix 2). The Short Form (SF-36) Health Survey scale,22 to assess patient satisfaction/quality of life, consists of 36 items that evaluate positive and negative health aspects covering the following categories: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each category is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. Both the DASH questionnaire and the SF-36 scale have been evaluated and validated in our environment by Spanish researchers23–25 showing adequate psychometric propierties to be applied to our patients. The Constant-Murley score unfortunately has not been validated in our country but its psychometric properties, together with those of other scales such as the DASH questionnaire has been recently reviewed.26 The DASH questionnaire and SF-36 scale, both of which are self-administered, were given to the study subjects at the first physical therapy evaluation and again 6 and 12 weeks after beginning treatment. The Constant-Murley score was administered by a physiotherapist not involved in patient treatment. Before beginning the study, all physiotherapists participating in the assessments were trained in the administration of this score to guarantee good interobserver validity. Active mobility was assessed with a goniometer, and in all cases, the patient was sitting with back support to avoid compensations. Muscle strength was evaluated with a dynamometer with the patient in supine position. The patient was asked to perform a static five seconds abduction contraction (with the shoulder at a 90º abduction angle, or the maximum abduction tolerated by the patient), with the elbow extended and the forearm in neutral pronosupination (Figure 1). The result was expressed as the average of three attempts. The score was administered in the first assessment and then repeated after 6 and 12 weeks.
Random allocation In order to randomize the assignment of patients to treatment groups and blind both patients and
Clinical Rehabilitation
Figure 1. Strength. Constant-Murley score.
researchers to the randomization sequence, we used permuted block randomization to generate groups of various sizes (six and nine assignments each to avoid any type of learning phenomenon) until a suitable sequence was created with up to 120 randomized numbers. The sequence was generated and blinded by individuals not involved in the assignment of the treatment groups, introducing each assignment into sequentially numbered, opaque envelopes which remained unopened until after obtaining informed consent and carrying out the first evaluation.
Intervention Before the envelope with the patient’s group assignment was opened, each patient was given an initial physical therapy evaluation by a trained physiotherapist. After assessing each patient, the physiotherapist of the corresponding health clinic administered treatment according to the guidelines of the patient’s assigned group. All patients received 15 daily sessions from Monday to Friday of one of the following regimens: The control group received treatment consisting of the application of an ultrasonophoresis placebo, an iontophoresis placebo, and a standard set of supervised exercises followed by 10 minutes of cryotherapy. The iontophoresis group underwent an ultrasonophoresis placebo, iontophoresis treatment, and a standard set of supervised exercises followed by 10 minutes of cryotherapy.
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García et al. The ultrasonophoresis group received ultrasonophoresis treatment, an iontophoresis placebo, and a standard set of supervised exercises followed by 10 minutes of cryotherapy.
Intervention variables Iontophoresis: 5x5 electrodes with an intensity of 0.1-0.2 mA/cm2 were applied for 10 minutes. The topical application used was sodium diclofenac (75 mg vials of diclofenac), administered under the active electrode (cathode). The placement alternated: one day, the active electrode was placed on the insertion site of the supraspinatus tendon with the non-active electrode placed on the infraspinatus insertion. The next day, the electrodes were placed on the opposite insertion sites. Ultrasonophoresis: The effective radiation area (ERA) in our study was 5 cm2, at 1 MHz, continuous mode (100%), and 0.7 W/cm2, with a treated area four times the ERA and with a bearn nonuniformity radio (BNR) less than 5. The treatment lasted for five minutes (three minutes in the insertion of the supraspinatus and two minutes in the infraspinatus insertion). Sodium diclofenac gel was used as the topical medium. The basis of treatment consisted of supervised physical exercises (supplementary material Appendix 3), followed by cryotherapy (application of a cold pack) for 10 minutes. We decided to use supervised exercises as the basis of treatment in all groups as they constitute one of the few physiotherapy techniques used in impingement syndrome which have been proven effective in high-quality clinical trials.7 In this manner, each patient was guaranteed a treatment with proven effectiveness. The exercise protocol was elaborated based on the systematic review written by Kuhn27 in 2009, in which it was postulated that exercise produces both clinically and statistically significant pain reduction and improved shoulder function, and stated that this evidence-based protocol can be used by clinicians treating impingement syndrome and can serve as a gold standard to reduce variables in future cohort and comparative studies to help find better treatments for patients with this disorder.27 The administration of the placebos versus treatment was carried out as follows:
In the case of ultrasonophoresis, first a non-steroidal anti-inflammatory drug gel was applied to the head of the device, which was then applied without pressure to the patient, who was positioned with his/ her back to the machine. For the groups receiving placebo ultrasonophoresis, the non-steroidal antiinflammatory drug gel was also applied to the head of the device, we simulated turning the machine on (although it remained off throughout the procedure) and then set the timer for 5 minutes. When the time had elapsed, we simulated turning off the machine manually. For the group that received ultrasonophoresis treatment, treatment was administered normally, but the timer was set for over 5 minutes so that no sound was emitted when the machine was turned off manually after 5 minutes. The administration of iontophoresis was carried out by first placing a gauze with a non-steroidal antiinflammatory drug gel onto the spontex of the active electrode. The patient was placed with his/her back to the machine, which was kept covered so the patient couldn’t see it. The administration of the placebo was performed by placing a gauze with a non-steroidal anti-inflammatory drug gel onto the spandex of the active electrode and activating the channel that was not applied to the patient (the apparatus is equipped with 2 separate channels) so that the channel being applied transmitted no active current, but the timer still sounded after 10 minutes had elapsed. For iontophoresis treatment, the channel applied to the patient was activated.
Data analysis Results are presented as the mean ± standard deviation (quantitative indicators) and as absolute and relative frequencies (percentages) in the case of qualitative indicators. The effect of each treatment – ultrasonophoresis or iontophoresis – together with the exercises was expressed as the change observed at 6 and 12 weeks with respect to the baseline, calculated with the aid of an analysis of covariance (ANCOVA). In the ANCOVA models, baseline levels were included as covariates. Assumptions for parametric tests like the ANCOVA were checked (linearity, homocedasticity, and normality of residuals). All calculations were
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Clinical Rehabilitation
Figure 2. CONSORT flow diagram.
controlled for age, sex, and dominance of the affected limb. We used an alpha value of 0.05 to establish statistically significant differences. The group to which each patient was assigned was maintained in the analysis regardless of the treatment finally received (intention to treat analysis). Random allocation was preserved and an intention to treat analysis was conducted. All calculations were performed with the IBM SPSS statistics package, version 19.
Results A total of 175 subjects were given information of whom 88 agreed and also met the inclusion/exclusion criteria and were randomized, 10 of whom discontinued treatment after receiving at least one therapeutic session and before the end of the 15th session or before completing the 12-week assessment. Therefore 78 subjects were analyzed.
See CONSORT flow diagram (Figure 2). Table 1 gives a description of each group with regard to sex, age, affected limb, and duration of disease. There was a slight predominance of women, with a mean age near to 60 years. In over half the cases the duration of disease was more than 6 months before starting recruitment. No relevant or significant differences were observed between groups for any of these variables. In relation to the questionnaire DASH we did not observe neither relevant nor statistically significant changes in relation to the type of therapy received. Both at 6 and 12 weeks no significant changes are observed in patients with ultrasonophoresis or iontophoresis compared to those who received only exercises (Tables 2 and 3). For the Constant-Murley score we observed a significant improvement associated to ultrasonophoresis at 6 and 12 weeks. This change was mainly due to the improvement of the “range of movement”
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García et al. Table 1. Characteristics of treatment group subjects. Variable Sex Male Female Mean age ± SD Affected limb Not dominant Dominant Duration of disease < 6 weeks 6 wks. – 3 months 3 – 6 months > 6 months
Exercise (n=29)
Ultrasonophoresis (n=27)
Iontophoresis (n=22)
10 (34.5%) 19 (65.5%) 56.9 ± 12.3
12 (44.4%) 15 (55.6%) 61.9 ± 13.0
9 (40.9%) 13 (59.1%) 57.7 ± 17.3
7 (24.1%) 22 (75.9%)
11 (40.7%) 16 (59.3%)
11 (50%) 11 (50%)
1 (3.4%) 11 (37.9%) – 17 (58.6%)
3 (11.1%) 8 (29.6%)
1 (4.5%) 8 (36.4%)
– 16 (59.3%)
– 13 (59.1%)
dimension and to a lesser extent to the improvement of pain, mainly at twelve weeks. The SF-36 dimensions of physical role and bodily pain were the most affected. However, the baseline values for the assessment scales used were not statistically different among the three groups (Table 2). The values of the scales at 6 and 12 weeks are also given in Table 2 and Table 3 respectively. In general, higher values were observed in the ultrasonophoresis group. With respect to the baseline levels and in comparison to the exercise group, the levels for the ultrasonophoresis and iontophoresis groups at 6 and 12 weeks point to significant differences in favor of ultrasonophoresis. These differences remain after adjusting for age, sex, and affected limb dominance. Thus, patients who underwent ultrasonophoresis experienced relevant and significant improvements in their levels of bodily pain (SF-36. 12.7 and 13.5 points after 6 and 12 weeks of therapy, respectively). The Constant-Murley score increased to 4.9 points after 6 weeks and to 6.4 points, after to 12 weeks; and vitality, dimension of the SF36 scale, reached 9.5 points in 12 weeks. Mental health (SF-36) also showed a marked improvement (8.9 points) after 12 weeks, in the ultrasonophoresis group. However, in the group of iontophoresis, neither statistically, nor clinically relevant significant differences were observed. Residuals of the models did not deviate significantly from normality (Kolmogorov test) and showed no significant heterocedasticity (assessed by graphical methods).
Discussion Our study shows that adding ultrasonophoresis to a program of supervised exercises may lead to significant improvements in patients with impingement syndrome as compared to patients undergoing the exercise program alone. Subjects in the ultrasonophoresis group experienced significant decreases in pain compared to the standard treatment group (12.7 and 13.5 points in “bodily pain” dimension of SF-36 scale; and 1.5 and 2.2 points in “pain” dimension of Constant-Murley score after 6 and 12 weeks of therapy, respectively). They also reported an improved range of motion compared to the exercises group (2.1 points after 6 weeks and 12 weeks in “range of movement” dimension of Constant-Murley score). With respect to the ability of a patient to perform certain upper extremity activities (assessed with DASH questionnaire and “activities of daily living” dimension of Constant-Murley score), we did not observe either or relevant nor statistically significant changes in relation to the type of therapy received. All patients group improved strength after treatment, and the values for the assessment of the different scales were not statistically different among the three groups; however higher strength values were observed in the ultrasonophoresis group compared to the exercises group (1.6 points in “strength” dimension of Constant-Murley score). Mental health and vitality (SF-36 dimensions) also showed a marked improvement in the ultrasonophoresis group compared to the standard treatment (8.9 points and
53.7 (15.1) 51.4 (13.9) 4.5 (3.4) 12.6 (3.8) 27.6 (6.7) 6.9 (4.4) 64.1 (28.1) 41.1 (42.6) 54.1 (19.2) 58.3 (21.0) 56.7 (22.6) 76.4 (28.9) 66.7 (45.3) 66.1 (23.1)
DASH Constant Murley Pain Activities of day living Range of movement Strength SF36–Physical functioning SF36–Role-Physical SF36–Bodily Pain SF36–General Health SF36–Vitality SF36–Social Functioning SF36–Role-Emotional SF36–Mental Health
51.8 (13.6) 50.8 (12.8) 2.8 (3.2) 12.4 (3.8) 28.6 (6.3) 7.5 (3.9) 66.9 (21.9) 43.5 (43.1) 48.3 (19.4) 54.1 (18.0) 53.5 (19.4) 77.3 (23.5) 74.1 (40.6) 67.4 (22.8)
US group 55.8 (15.7) 47.9 (8.4) 3.9 (3.4) 12.0 (3.5) 26.0 (5.0) 6.1 (3.1) 63.4 (24.8) 48.9 (42.6) 51.5 (28.1) 54.8 (22.1) 53.4 (24.9) 72.0 (30.1) 68.2 (41.8) 62.7 (26.1)
IP group −9.6 17.4 3.1 4.6 6.4 3.2 4.4 20.9 4.6 1.8 0.7 7.4 2.1 3.0
Exercises group −9.3 21.1 5.6 5.6 7.3 2.4 5.3 15.2 16.0 –0.1 4.1 4.5 1.9 –0.6
US group −3.6 14.9 4.1 4.6 4.6 1.9 –0.1 4.7 5.2 –0.7 4.5 3.0 1.6 7.0
IP group
Change from baseline at 6 weeks
−1.9 (–7.2 to 3.3) 4.9 (0.2 to 9.6)* 1.5 (–0.5 to 3.5) 0.7 (–0.5 to 2.0) 2.1 (–0.04 to 4.2) −0.1 (–1.7 to 1.5) 1.2 (–6.3 to 8.6) −4.2 (–27.3 to 19.0) 12.7 (2.8 to 22.6)* –4.5 (–11.4 to 2.3) 5.4 (–2.2 to 13.1) –0.3 (–10.9 to 10.2) 6.7 (–12.5 to 25.9) 0.6 (–6.7 to 7.9)
Advantage for US group (95% CI)
US: Ultrasonophoresis, IP: Iontophoresis. Advantage (95% Confidence Interval) in relation to exercises group (reference) adjusted for age, sex, dominant limb affected. *P
