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research report

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ANAT SHASHUA, MPT1 • SHLOMO FLECHTER, MD, PhD2 • LIAT AVIDAN, BPT1 DANI OFIR, BPT1 • ALEX MELAYEV, BPT1 • LEONID KALICHMAN, PT, PhD3

The Effect of Additional Ankle and Midfoot Mobilizations on Plantar Fasciitis: A Randomized Controlled Trial

H

eel pain is a common phenomenon, occurring in approximately 10% of the population over a lifetime,7,10,28 and the leading cause of treatment for foot and ankle pathologies.33 Of the pathologies that cause heel pain, the most common is plantar fasciitis (PF).33 To date, it has been demonstrated that this condition is not characterized by inflammation but rather by noninflammatory degenerative changes of the plantar fascia that cause TTSTUDY DESIGN: A single-blind randomized controlled trial.

TTOBJECTIVE: To evaluate the efficacy of ankle

and midfoot mobilization on pain and function of patients with plantar fasciitis (PF).

TTBACKGROUND: Plantar fasciitis is a degenerative process of the plantar fascia, with a lifetime prevalence of approximately 10%. Limited ankle dorsiflexion is a common finding and apparently acts as a contributing factor to the development of PF.

TTMETHODS: Fifty patients with PF, aged 23

to 73 years, were randomly assigned to either the intervention or control group. Both groups received 8 treatments, twice a week, consisting of stretching exercises and ultrasound. In addition, the intervention group received mobilization of the ankle and midfoot joints. Dorsiflexion range of motion was measured at the beginning and at the end of treatment. The results were evaluated by 3 outcomes: the numeric pain-rating scale, Lower Extremity Functional Scale, and algometry.

TTRESULTS: No significant difference was found

between groups in any of the outcomes. Both groups showed a significant difference in the numeric pain-rating scale and Lower Extremity Functional Scale. Both groups significantly improved in dorsiflexion range of motion, with no difference between groups.

TTCONCLUSION: The addition of ankle and foot

joint mobilization aimed at improving dorsiflexion range of motion is not more effective than stretching and ultrasound alone in treating PF. The association between limited ankle dorsiflexion and PF is most probably due to soft tissue limitations, not the joints. Trial registered at ClinicalTrials.gov (registration number NCT01439932).

TTLEVEL OF EVIDENCE: Therapy, level 1b. J Or-

thop Sports Phys Ther 2015;45(4):265-272. Epub 4 Mar 2015. doi:10.2519/jospt.2015.5155

TTKEY WORDS: ankle joint, dorsiflexion, joint mobilizations, plantar fascia

microscopic tears when it inserts into the calcaneus. This condition is better referred to as fasciopathy or fasciosis.7,17,28 Plantar fasciitis is characterized by pain at the bottom of the heel and along the medial border of the plantar fascia.7,28,33 The pain is usually aggravated in the morning, with the first step after getting out of bed or after prolonged sitting (non–weight bearing). The literature suggests several hypotheses as to the factors that may contribute to PF, divided into external factors (eg, as prolonged standing, inappropriate footwear, previous injuries, and highload running) and internal factors (eg, anatomical and biological characteristics comprising limited first metatarsophalangeal joint movement, limited ankle dorsiflexion [DF], asymmetric leg length, thickening of the plantar fascia, foot hyperpronation, weakness of calf muscles, spur, older age, and a high body mass index).19 A number of studies have indicated that limited ankle DF may be a factor associated with PF,22,25,29,33 which may cause, as a compensation, increased stress on the plantar fascia. This hypothesis is based on the theory that ankle DF of less

Bat-Yamon Physical Therapy Clinic, Clalit Health Services, Tel Aviv, Israel. 2Bat-Yamon Medical Center, Clalit Health Services, Tel Aviv, Israel. 3Department of Physical Therapy, The Leon and Matilda Recanati School for Community Health Professions, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel. The study was approved by the Helsinki Committee of Clalit Health Services and registered on the National Institutes of Health website ClinicalTrials.gov (registration number NCT01439932). The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the article. Address correspondence to Anat Shashua, 10 Feldman Street, Nes-Ziona 74058 Israel. E-mail: [email protected] t Copyright ©2015 Journal of Orthopaedic & Sports Physical Therapy® 1

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[ than 10° during gait may cause abnormal compensatory pronation of the subtalar joint, which in turn may increase stress on the plantar fascia.16,19 Three studies have specifically examined ankle DF range of motion. Riddle et al29 found that limited ankle DF significantly increased the risk of PF. The other 2 studies found no significant difference between a case group with PF and a control group without PF.18,26,30 Therefore, additional studies are needed to evaluate the possible association of ankle DF range of motion with PF. Treatment options for PF are controversial.8,10,19,25 The Cochrane review from 201010 examined 19 randomized trials that included treatment by steroid injections, shockwaves, night splints, orthotics, and heel pads. Most of the treatment options produced a marginal advantage compared to no treatment or a control treatment, such as stretching. Guidelines of the Orthopaedic Section of the American Physical Therapy Association from 200825 cited additional treatments but also found no clear advantage to these treatments compared to a placebo or control treatment, and a lack of strong evidence from randomized controlled trials to support them. Manual therapy for PF includes soft tissue manipulation techniques, mobilization, and manipulation of the ankle and foot joints. A number of case series have demonstrated rapid improvement in pain and function following mobilization and manipulation techniques to the talocrural, subtalar, and first tarsometatarsal joints, supporting further study in randomized controlled trials.25 In a randomized controlled trial by Renan-Ordine et al,28 manual techniques for soft tissue release combined with stretching exercises were compared with stretching exercise alone. It was assumed that the presence of myofascial trigger points in the calf muscles would create stiffness and therefore reduce the effectiveness of the stretching exercises. They used trigger point pressure-release and neuromuscular techniques over the

research report gastrocnemius muscle. The outcomes showed improvement in both groups, with significant improvement in the intervention group in physical function (measured by the Medical Outcomes Study 36-Item Short-Form Health Survey quality-of-life questionnaire) and pain intensity (measured by pressure pain threshold). Cleland et al7 compared manual therapy and exercise with electrophysical therapy and exercise. The control group was treated by iontophoresis with dexamethasone and stretching exercises. The intervention group received the same stretching exercise protocol combined with various manual techniques, including soft tissue massage; mobilization; and manipulation of the talocrural joint, rearfoot complex, tibiofibular joint, and intertarsal joint. When knee or hip joint impairments were found, manual techniques were performed. The outcome measures included 2 patient self-report questionnaires (the Lower Extremity Functional Scale [LEFS] and the Foot and Ankle Ability Measure) and a numeric pain-rating scale (NPRS) for heel pain. The manual therapy group demonstrated a significant improvement in pain and function outcomes. Due to the diverse manual techniques (soft tissue as well as joint mobilizations) and involvement of joints distant from the foot (knee and hip), it was difficult to conclude whether the joint mobilizations applied on ankle and foot joints had any therapeutic effect. To date, studies have mainly reported on soft tissue techniques to improve range of motion in patients with PF. Previous studies found that ankle joint mobilization and manipulation improved the range of ankle DF.2 Despite the evidence that limited ankle DF may be a contributing factor to PF,22,25,33 no interventional study has examined the direct correlation between increase in ankle DF following treatment and decrease in PF symptoms. The aim of this study was to evaluate the effect of ankle, subtalar, and midfoot joint mobilizations on pain and function in patients with PF. We hypothesized that

] mobilization of these joints, in addition to conventional physical therapy, would significantly improve pain and function in patients with PF, as opposed to conventional treatment alone.

METHODS Design

A

n interventional, prospective, single-blind randomized controlled trial.

Setting All study procedures were performed at the Bat-Yamon Physical Therapy Clinic of Clalit Health Services, Tel Aviv District, Tel Aviv, Israel.

Sample Recruitment occurred from October 2011 through December 2012 (a period of 15 months). The study participants were enrolled and recruited from patients who were receiving physical therapy treatment and were diagnosed with PF or a calcaneal spur. Inclusion criteria were as follows: aged 18 to 75 years, pain at the bottom of the heel generated by pressure, and an increase in pain (NPRS, greater than 3) in the morning on taking a few steps or after prolonged non–weight bearing. Exclusion criteria were as follows: tumors, prolonged use of steroids, below-theknee fracture occurring during the last year, prior foot surgeries, tarsal tunnel syndrome, fat-pad syndrome, pregnancy, and not being available in the coming month. The study was approved by the Helsinki Committee of Clalit Health Services in Meir Hospital, Kfar Saba, Israel. All patients signed an informed-consent form prior to participation, and the rights of the subjects were protected. The study was registered at ClinicalTrials.gov (registration number NCT01439932).

Sample-Size Estimation The sample-size calculation was performed by using an online power/ sample-size calculator (http://stat.ubc. ca/~rollin/stats/ssize/n2.html). Calcu-

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lations were based on the following parameters: 2-sided test, power of 0.80, alpha of .05, a difference of 1.4 between the average NPRS scores of the 2 groups, and standard deviation of 1.5 (NPRS and standard deviation data were taken from a previous study).7 The effect size was 0.93. The number of subjects in each group, according to this calculation, was 20. Due to the possibility of dropouts, 50 participants were recruited to provide approximately 25 participants per group.

Allocation Participants were randomly assigned to groups following a simple randomization procedure. Fifty opaque, sealed envelopes were prepared in advance, containing cards with the name of the study group, of which 25 were for the control group and 25 for the intervention group. All sealed envelopes were thoroughly mixed. At the end of baseline evaluation, the examiner randomly picked up the consequent envelope and gave it to the physical therapist who performed the treatment. Cards with a group name were returned to the examiner at the end of the study, after all evaluations were completed. The examiner was blinded to patient allocation.

Outcome Measures Baseline and final assessments were performed by a physical therapist (A.S., the examiner) who was blinded to the study group. Baseline evaluation included demographic data collection, medical history, and physical examination. Demographic data included age, sex, weight, height, body mass index (kg/m2), history, physical activity (participation, type of activity, and hours per week), occupation, and general health of the patient. Physical examination included observation of gait pattern (categorized as normal, limping, toe touch, or other). Palpation was performed for local heat or swelling and for local pain at the medial calcaneal tuberosity. Participants with clinical symptoms of pain in the middle of the heel that were aggravated by walking on hard

surfaces or with a history of heel trauma were excluded for suspicion of fat-pad syndrome.8,33 Three signs to differentially diagnose tarsal tunnel syndrome were assessed to exclude this pathology: presence of numbness or burning pain,1 Tinel sign, and neurodynamic test. The Tinel sign was found to be positive in tarsal tunnel syndrome and medial plantar nerve entrapment by Schon and Baxter in 1990.32 The modified straight leg raise test with ankle DF/eversion was found to be a valuable tool to differentiate plantar heel pain of neural origin from other common conditions such as PF.1,23 Because none of these tests can provide an accurate answer, any participant with a positive test of tarsal tunnel syndrome was excluded. Dorsiflexion range of motion was measured in both legs (FIGURE 1). Measurement was performed in the lunge position. The patient stood against the wall with the measured leg in front and toes pointing to the wall. The patient was asked to maximally bend the knee toward the first toe without lifting the heel. An inclinometer was placed on the anterior aspect of the tibia, and the recorded angle to the vertical was the ankle DF. The high reliability (intraclass correlation coefficient [ICC] = 0.96-0.99) of this method has been previously demonstrated, with a minimal clinically important difference (MCID) of 3.7° to 3.8°.24 Finally, the 3 outcome measures—the NPRS, LEFS, and algometry—were conducted. The NPRS is a valid and reliable tool for assessing pain intensity20,21,27 and is a common outcome in PF studies.7,13,34 Pain score according to the NPRS (0-10), taken during the first steps in the morning, was the primary outcome (0 as “no pain” and 10 as “very severe pain”). The MCID has been shown to vary between 1.7 points14 and 2 points31 for chronic musculoskeletal pain. Pain score was measured 4 times during the study: at baseline, after 4 sessions, at the end of all treatment sessions, and after a 6-week follow-up. The LEFS consists of 20 questions in-

FIGURE 1. Methods of ankle dorsiflexion evaluations.

volving everyday functional activities and is used to assess lower extremity disorders. The questionnaire was developed by Binkley et al in 19994 and found to have high reliability and validity (test-retest reliability, 0.94; 95% lower-limit confidence interval [CI]: 5.89 and correlation with the quality-of-life questionnaire Medical Outcomes Study 36-Item ShortForm Health Survey, 0.8; 95% lowerlimit CI: 5.73). The maximum score indicating a high functional level was 80, and the MCID was 9 points (90% CI).4 The questionnaire was translated into Hebrew and validated as part of a computerized adaptive evaluation system.11,12 The LEFS score was measured 4 times during the study: at baseline, after 4 sessions, at the end of all treatment sessions, and after a 6-week follow-up. Algometry measures the minimum pressure required to produce pain and consists of a flat, 1-cm2 disc connected to a manometer. The disc was placed vertically on the point of pain, with the therapist increasing the pressure intensity until the initial pain appeared (when the feeling of pressure became painful). The score was determined by averaging 3 repeated measurements, with a 30-second break between each. Algometry facilitates an objective assessment of pain

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research report

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Subjects with PF screened for eligibility, n = 78

Subjects excluded, n = 25 • Absence of pain at first steps in the morning, n = 7 • Language difficulties, n = 6 • Unavailability, n = 5 • Age, n = 3 • Previous foot fracture/ surgery, n = 2 • Health condition, n = 2

Subjects meeting the inclusion criteria, n = 53

Agreed to participate and signed informed consent, n = 50

Randomization

Control group, n = 25

Intervention group, n = 25

Midterm evaluation (after 4 sessions), n = 23 • Dropped out due to dissatisfaction, n = 2

Midterm evaluation (after 4 sessions), n = 24 • Dropped out due to family problem, n = 1

End-of-treatment evaluation, n = 23

End-of-treatment evaluation, n = 23 • Dropped out due to health problem, n = 1

6-wk follow-up evaluation, n = 23

6-wk follow-up evaluation, n = 23

FIGURE 2. Flow diagram of subject recruitment and retention. Abbreviation: PF, plantar fasciitis.

in addition to the NPRS, a subjective assessment. Algometry was found to be valid and reliable in repeated measurements (interrater, intrarater) over normal muscles in healthy people, with an MCID

of 14.71 to 19.61 N/cm2.15 Chesterton et al6 found high reliability when the 3 repeated measures were averaged: ICC = 0.91 (95% CI: 0.82, 0.97); MCID, 17.39 N/cm2. Algometry was measured twice

] during our study: at baseline and at the end of all treatment sessions.

Intervention Treatments were performed by 3 physical therapists at the Bat-Yamon Clinic. The physical therapists had at least 3 years of experience and appropriate training. In the present study, participants in both groups received 8 sessions over a 4-week period. Both groups received explanations and training as to stretching exercises for the plantar fascia and triceps surae muscles. Throughout the study, patients were asked to perform 2 sets, lasting 30 seconds, 3 times a day for each exercise, as recommended by previous studies7,25 (APPENDIX A, available at www.jospt.org). All patients received information and guidance for practice at home. Participants in both groups received therapeutic ultrasound over the most tender area. Despite lack of randomized controlled trials and weak evidence supporting therapeutic ultrasound efficacy in the management of PF, clinicians continue to use this therapy. It is a popular and common treatment among physical therapists worldwide7 and in the Clalit Health Services, the largest health care provider in Israel (Clalit internal statistics). The following parameters were used: frequency of 1 MHz, 1.5 W/cm2, 50% pulses for 5 minutes. Dosage was calculated based on previous studies, the manufacturer’s protocol, and guidelines published at www. electrotherapy.org. In addition, the intervention group received a number of manual techniques, including anterior/posterior talocrural joint mobilization under both weightbearing and non–weight-bearing conditions, for improving DF range of motion, subtalar joint mobilization for eversion and inversion, and mid-tarsal mobilization for pronation and supination of the midfoot. Each technique was executed for 1 to 1.5 minutes (a total of 5 minutes per manual treatment) (APPENDIX B, available at www.jospt.org). At the end of all treatment sessions, all patients underwent

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reassessment, which included symptom behavior, gait pattern, DF range of motion, and the 3 outcome measures. The NPRS morning score and LEFS questionnaire were carried out after 4 sessions and by telephone 6 weeks after cessation of treatment. In patients with bilateral PF, only the more painful foot was used for this study. The other foot received standard treatment, and data on this foot were not collected.

Statistical Analysis Statistical analysis was performed using SPSS Version 17 for Windows (SPSS Inc, Chicago, IL). The outcome variables and DF range of motion were compared using a repeated-measures approach for the main effect of time and the groupby-time interaction. Comparisons to patients with limited DF were performed with the Mann-Whitney U test for nonparametric variables due to the small number of subjects in each group. All statistical analysis was conducted using the intention-to-treat approach. The missing-completely-at-random test confirmed that data were missing at random, and the missing values were replaced by predicted values using the expectation maximization technique.

RESULTS

S

eventy-eight patients with PF were screened during the study period. Twenty-five did not meet the inclusion criteria and 3 refused to participate. Fifty patients (15 men, 35 women; age range, 23-73 years; mean  SD age, 51.32  12.58 years) met the inclusion criteria and were included in the study. Duration of symptoms ranged from 1 to 24 months (mean  SD, 5.91  5.13 months). Forty-six patients completed the study and 4 dropped out (1 man and 1 woman from the intervention group and 2 women from the control group) (FIGURE 2). The age range of the dropouts was 29 to 45 years (younger on average than other participants). No differences were

TABLE 1 Variables

Demographic and Baseline Characteristics* Intervention Group (n = 25)

Control Group (n = 25)

18 (72)

17 (68)

7 (28)

8 (32)

Sex, n (%) Female Male Age, y

54.16  13.04

48.48  11.68

BMI, kg/m2

29.00  4.79

30.36  4.42

Symptom duration, mo

5.28  4.54

6.54  5.69

Dorsiflexion RL, deg

39.88  8.96

39.68  6.14

Dorsiflexion OL, deg

39.88  9.63

41.80  5.99

7.76  2.03

8.12  1.72

NPRS (0-10) LEFS (0-80)

40.00  16.48

48.16  17.06

Algometry, Pa

423.17  176.42

365.52  200.65

Abbreviations: BMI, body mass index; LEFS, Lower Extremity Functional Scale; NPRS, numeric pain-rating scale; OL, other leg; RL, reference leg. *Values are mean  SD unless otherwise indicated.

found in other baseline characteristics between dropouts and other participants. Thirty-six patients attended all 8 sessions (18 patients from each group), 4 patients attended 7 of 8 sessions (2 patients from each group), 4 other patients attended 6 of 8 sessions (2 patients from each group), and 2 other patients attended 5 of 8 sessions (1 patient from each group). The reasons for not attending all sessions were unavailability, satisfactory improvement, or lack of improvement. Initially, baseline data were compared, and no differences were found between groups in all baseline characteristics (TABLE 1). In the group-by-time interaction, no significant difference was found in any of the 3 outcomes, as well as in DF range of motion (TABLE 2). In the comparison between patients whose DF range of motion was initially limited (less than 35°) and patients with a DF range of motion of 35° or greater, a significant difference was found in the relative change of the DF range of motion in favor of the limited patients (P = .021). No difference was found in the relative change in NPRS and LEFS scores between these subgroups.

No significant correlation was found between improvement in DF range of motion and improvement in NPRS and LEFS scores (P = .395 and P = .066, respectively). For the within-group comparison, NPRS and LEFS scores improved significantly in both groups (P

The effect of additional ankle and midfoot mobilizations on plantar fasciitis: a randomized controlled trial.

A single-blind randomized controlled trial...
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