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Y E p M a b a A R R A K P M M 1 m t t t n p r ( h 0 ARTICLE IN PRESSG Model FOOT-1313; No. of Pages 6 The Foot xxx (2014) xxx–xxx Contents lists available at ScienceDirect The Foot journa l h om epage: www.elsev ier .com/ locate / foot ffectiveness of myofascial release in the management of plantar heel ain: A randomized controlled trial .S. Ajimshaa,b,∗, D. Binsub, S. Chithrab Department of Physiotherapy, Hamad Medical Corporation, Doha, Qatar Myofascial Therapy and Research Foundation, India r t i c l e i n f o rticle history: eceived 11 December 2013 eceived in revised form 7 March 2014 ccepted 11 March 2014 eywords: lantar heel pain yofascial restrictions yofascial release a b s t r a c t Background: Previous studies have reported that stretching of the calf musculature and the plantar fas- cia are effective management strategies for plantar heel pain (PHP). However, it is unclear whether myofascial release (MFR) can improve the outcomes in this population. Objective: To investigate whether myofascial release (MFR) reduces the pain and functional disability associated with plantar heel pain (PHP) in comparison with a control group receiving sham ultrasound therapy (SUST). Design: Randomized, controlled, double blinded trial. Setting: Nonprofit research foundation clinic in India. Method: Sixty-six patients, 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks. The Foot Function Index (FFI) scale was used to assess pain severity and functional disability. The primary outcome measure was the difference in FFI scale scores between week 1 (pretest score), week 4 (posttest score), and follow- up at week 12 after randomization. Additionally, pressure pain thresholds (PPT) were assessed over the affected gastrocnemii and soleus muscles, and over the calcaneus, by an assessor blinded to the treatment allocation. Results: The simple main effects analysis showed that the MFR group performed better than the con- trol group in weeks 4 and 12 (Phttp://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0145 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0145 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0145 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0145 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0145 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0145 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0150 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http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0160 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0160 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0160 http://refhub.elsevier.com/S0958-2592(14)00013-3/sbref0160 Effectiveness of myofascial release in the management of plantar heel pain: A randomized controlled trial 1 Introduction 2 Methods 3 Outcome measures 3.1 Foot Function Index (FFI) 3.2 Pressure pain thresholds (PPT) 4 Study protocol 4.1 MFR technique 4.1.1 MFR for gastrocnemius 4.1.2 MFR for soleus 4.1.3 MFR for plantar myofasciae 4.2 Control intervention 5 Statistics 6 Results 6.1 Changes in pressure pain thresholds 7 Discussion 8 Study limitations 9 Conclusions 9.1 Implications Acknowledgments Referenceswith the following clin- cal features [17–19]: (1) insidious onset of sharp pain under the lantar heel surface upon weight bearing after a period of non- eight bearing; (2) plantar heel pain that increases in the morning ith the first steps after waking up; and (3) symptoms decreas- ng with slight levels of activity, such as walking. Clinical history ntake of the participants included questions related to the onset f pain and duration of the symptoms, and previous medication nd treatments. Patients were excluded if they exhibited any of he following: (1) red flags to manual therapies (i.e., tumor, frac- ure, rheumatoid arthritis, osteoporosis, severe vascular disease, tc.), (2) bilateral plantar heel pain, (3) prior surgery in the lower xtremity, (4) diagnosis of fibromyalgia syndrome, or (5) previous anual therapy interventions for the foot region. The Research Ethics Committee of the Myofascial Therapy and esearch Foundation reviewed the study and raised no objections rom an ethical point of view. Between March 2011 and June 2013, 7 patients with a primary complaint of unilateral plantar heel pain Please cite this article in press as: Ajimsha MS, et al. Effectiveness o randomized controlled trial. Foot (2014), http://dx.doi.org/10.1016/j.f ere referred to the Myofascial Therapy and Research Foundation. f these, 66 individuals who met the inclusion criteria and provided ritten informed consent were randomized to the MFR or to the ontrol arm of the study. Participants were asked to maintain a PRESS t xxx (2014) xxx–xxx pain and medication diary in which any medication or change in pain pattern during the treatment period was to be recorded with date and time. Two evaluators blinded to the group to which the participants belonged analyzed scores from the FFI and PPT. 3. Outcome measures 3.1. Foot Function Index (FFI) FFI was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items that measure pain, disability, and activity restriction. Scoring is based on a visual analog scale [20,21]. The Foot Function Index has been reported to be reliable, valid, and sensitive to change in subjects with foot pathologies [20,21]. 3.2. Pressure pain thresholds (PPT) PPT is the minimal pressure when the sensation of pressure changes to pain [22] was assessed with a mechanical pressure Algometer (Baseline FPK 20). The device consists of a round rub- ber disk (1 cm2) attached to a force gauge (kg). The pressure (force divided by the surface area) was applied at a rate of approximately 0.1 kg/cm2/s. The mean of 3 trials was calculated for each tested location and used for the main analysis. Thirty seconds were used between each trial. To investigate hypoalgesic effects of both inter- ventions, PPT was assessed at 3 predetermined locations on the affected leg: gastrocnemii (middle point over the muscle belly), soleus (centered point of the muscle belly at 10 cm over Achilles tendon) muscles, and over the posterior aspect of the calcaneus by a blinded assessor. The reliability of algometry has been reported to be high (intraclass correlation coefficient [ICC] = 0.91; 95% CI: 0.82, 0.97) [23,24]. In the current study, intra-examiner reliability was calculated from the 3 trials over each location and ranged from 0.92 to 0.95, suggesting high repeatability of the measurement. 4. Study protocol The 2 interventions were provided 3 times weekly for 4 weeks (weeks 1–4), with a minimum of a 1 day gap between the 2 sessions; the duration of each treatment session was 30 min. Both groups were treated by clinicians blinded to the group and the outcome of the study. Both the treatments were only applied to the affected side. Outcome measures were captured at Week 1 (pretest score), Week 4 (posttest score), and follow-up at Week 12 after random- ization. Patients were unaware of the true objective of the study in that they were aware of the ethical implications without revealing the details of the intervention that was being evaluated. All sub- jects were informed of the true nature of the study at the end of the study. 4.1. MFR technique We used the following treatment protocol for all the patients in the MFR group [15,16]. The techniques were administered by Physiotherapists certified in MFR who had been trained in the tech- niques for at least 100 h and with a median experience of 12 months with the technique. The protocol was as follows. f myofascial release in the management of plantar heel pain: A oot.2014.03.005 4.1.1. MFR for gastrocnemius Client’s position: Prone, with feet off the end of the table to allow for easy dorsiflexion. dx.doi.org/10.1016/j.foot.2014.03.005 ARTICLE IN PRESSG Model YFOOT-1313; No. of Pages 6 M.S. Ajimsha et al. / The Foot xxx (2014) xxx–xxx 3 f t f t d F m t c d t p t t B a p r 4 o t ( F a Fig. 1. MFR of the gastrocnemii using elbow. Therapist’s position: Facing toward head while standing at the oot end of the table for technique number 1 and 3, facing toward he feet while standing at the client’s side, at around mid-thigh level or technique number 2 and 3. Technique 1: Use an elbow flexed to 90◦ and take up a contact in he Tendo Achilles (Fig. 1). Establish a line of tension in a superior irection and slowly engage the tissues while the client dorsiflexes. ocus of the release will be at the junction of the tendon and the uscles (5 mts × 1 repetition). Technique 2: Use the index and middle fingers of each hand to ake up a contact on the tendons of the gastrocnemii at the epi- ondyles of the femur (Fig. 2). Put a line of tension in an inferior irection and slowly apply the pressure into the tendinous struc- ures of the posterior knee. Continue this down into the superior ortions of the fibrous part of the muscle, engage the tissues while he client dorsiflexes (5 mts × 1 repetition). Technique 3: Use the index, middle and ring fingers of each hand o get into the medial and lateral aspects of the calcaneus (Fig. 3). egin the release proximally, slowly establish a line of tension in n inferior direction and engage the tissue while the client com- letes 3 repetitions of dorsiflexion from plantar flexion (5 mts × 1 epetition). .1.2. MFR for soleus Client’s position: Prone with feet over a bolster to induce 10–15◦ f knee flexion and put the gastrocnemii off stretch. Therapist’s position: Facing toward the head while standing at Please cite this article in press as: Ajimsha MS, et al. Effectiveness o randomized controlled trial. Foot (2014), http://dx.doi.org/10.1016/j.f he foot end of the table. Technique: Use an elbow to contact into the Tendo Achilles Fig. 4). Apply pressure gradually through the tendon into the ig. 2. Finger placements for release of the gastrocnemii tendons in the posterior spect of the knee. Fig. 3. Initial finger placements for the release of the fascia at the calcaneus. investing layer of fascia that lies between the soleus and the gas- trocnemii. Take up a line of tension in a superior direction and engage the tissue while the client dorsiflexes (5 mts × 1 repetition). 4.1.3. MFR for plantar myofasciae Client’s position: Prone with feet off the end of the table to allow for easy dorsiflexion. Therapist’s position: Sitting on a stool at the end of the table. Technique: Use the knuckles to engage the soft tissue just ante- rior of the calcaneus (Fig. 5). Take up a line of tension in an anterior direction. Work to the ball of the foot as well as into deeper layers with toe flexion and extension from the patient’s side (5 mts × 2 repetitions). 4.2. Control intervention Patients in the control group received sham ultrasound ther- apy (SUST) over the gastrocnemii, soleus and plantar fascia in the same areas of the application of MFR (in the other group) for 30 min per treatment session, three times a week for 4 weeks. SUST units were prepared by removing the ultrasound producing quartz crys- tal fromthe treatment transducer head of the ultrasound therapy units without the knowledge of the attending therapist. After the completion of the study, patients in the control arm were provided MFR therapy, as advised by the ethics committee. 5. Statistics f myofascial release in the management of plantar heel pain: A oot.2014.03.005 Participants in both groups (MFR group, n = 34; control group, n = 32) were comparable at baseline, as shown in Table 1. The primary outcome measure was the difference in FFT scale scores between baseline (pretest score), Week 4 (posttest score), and Fig. 4. Soleus release with 10–15◦ of knee flexion. dx.doi.org/10.1016/j.foot.2014.03.005 ARTICLE IN PRESSG Model YFOOT-1313; No. of Pages 6 4 M.S. Ajimsha et al. / The Foot xxx (2014) xxx–xxx Fig. 5. Release of the plantar myofasciae using a soft fist. Table 1 Summary of baseline characteristics. Characteristics MFR group (n = 33) Control group (n = 32) Men:woman 7:26 10:22 Age (y) 42.4 ± 4.6 40.8 ± 7.1 Duration of condition (mo) 4.0 ± 0.6 4.1 ± 0.5 N f p m o o T g H s p M a 6 ( p o w p r 1 t T F N Body mass index (kg/m2) 26.3 ± 3.5 27.9 ± 5.0 ote: Data are mean ± SD or as otherwise noted. ollow-up at Week 12 after randomization. Additionally, pressure ain thresholds (PPT) were assessed over the affected gastrocne- ii and soleus muscles, and over the calcaneus. Statistical analysis f the data was done by using a 2 × 3 (group × time) analysis f variance (ANOVA) and repeated-measures of 2 × 3 ANOVAs. he between-groups (group), within-groups (time) and mixed roups (group × time) were examined by using Pillai trace, Wilk �, otelling trace and Roy largest root methods. We used Mauchly’s phericity test for validating the ANOVAs. In accordance with the rimary objective of the study, we compared the FFT scores of the FR and control groups at different time intervals. A Pmanage- ent of plantar heel pain is unclear, but they may be related to decrease in tension over the plantar fascia or decrease of risk actors, such as tightness of the gastrocnemii and soleus mus- les and restricted ankle dorsiflexion. A study by Meltzer et al. 25] has shown that treatment with MFR after repetitive strain njury resulted in normalization in apoptotic rate, cell morphol- gy changes, and reorientation of fibroblasts. It is possible that reatment with MFR in PHP may result in a halt in the degenera- ive process of the plantar fascia by facilitating the healing process nd the fascial architecture to return toward normality. According o Schleip [12], under normative conditions, fascia and connective Please cite this article in press as: Ajimsha MS, et al. Effectiveness o randomized controlled trial. Foot (2014), http://dx.doi.org/10.1016/j.f issues tend to move with minimal restrictions. However, injuries esulting from physical trauma, repetitive strain injury, and inflam- ation are thought to decrease fascial tissue length and elasticity, esulting in fascial restriction. It is also possible that pain relief due djustment). to MFR is secondary to returning the fascial tissue to its normative length by collagen reorganization; this is a hypothesis that mer- its investigation. It has also been proposed that compressing the sarcomeres by direct pressure, combined with active contraction or stretching of the involved muscle, may equalize the length of the sarcomeres and consequently decrease the pain [26]; however, this theory has not been scientifically investigated [27]. As with any massotherapy techniques, the analgesics effect of MFR can also be attributable to the stimulation of afferent pathways and the exci- tation of afferent A delta fibers, which can cause segmental pain modulation [28] as well as modulation through the activation of descending pain inhibiting systems [29,30]. However, the follow- up at Week 12 has shown that the treatment effects were less evident compared with Week 4 after the treatment. This may be explained because, at the 12-week follow-up, the treatment effect obtained may be disguised by the continuation of the daily activi- ties with the same causative factors or by the natural course of the disease. Additionally, we also found an increase in PPT over the affected leg within the MFR group. Again effect sizes were large, supporting a clinical effect of the intervention over mechanical pain sensitivity. Our results support that MFR treatment decreases pressure pain sensitivity, which is again in agreement with the previous studies on segmental antinociceptive effects [30,31]. 8. Study limitations One limitation of this trial was that we only conducted a short-term follow up. We do not know if these effects would be maintained for longer periods. In this study it was impossible to interpret weather MFR to the gastrocnemii, soleus or the plantar fascia brought the improvement. Future comparative analyses are advocated to find an answer to it. A slight improvement over time f myofascial release in the management of plantar heel pain: A oot.2014.03.005 “meaning response” [32]. It will be of interest if further studies can be conducted to compare the effectiveness MFR with established treatments like arch supports, self stretching or even with surgical procedures. dx.doi.org/10.1016/j.foot.2014.03.005 ING Model Y 6 he Foo 9 t a m b r 9 t p A a a s t R [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ [ ARTICLEFOOT-1313; No. of Pages 6 M.S. Ajimsha et al. / T . Conclusions The MFR investigated in this trial was more effective than a con- rol intervention with SUST for the treatment of PHP. MFR can be simple and cost effective addition to the non-surgical manage- ent of PHP. A significant proportion of individuals with PHP might enefit from the use of MFR. The mechanisms underlying these esponses merit further investigation. .1. Implications Physical therapists are advised to consider MFR as an adjunct to heir conservative managements for the treatment of plantar heel ain. cknowledgments We thank all the practitioners and professionals of MFTRF, India nd the physicians who participated in the consensus process and nalysis to establish the trial interventions. We are expressing our pecial gratitude to Mr. Shean Capati, PT, for his photo shoot assis- ance. eferences [1] Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physi- cian 2011;84:676–82. [2] Riddle DL, Pulisic M, Pidcoe P, Johnson RE. Risk factors for plantar fasciitis: a matched case–control study. J Bone Joint Surg Am 2003;85-A:872–7. [3] Rome K, Howe T, Haslock I. Risk factors associated with the development of plantar heel pain in athletes. Foot 2001;11:119–25. [4] Taunton JE, Ryan MB, Clement DB, McKenzie DC, Lloyd-Smith DR, Zumbo BD. A retrospective case-control analysis of 2002 running injuries. 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