| CTRI Number |
CTRI/2018/06/014667 [Registered on: 29/06/2018] Trial Registered Prospectively |
| Last Modified On: |
26/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Self Myofascial Release Technique on leg Pain And activities of daily living For Heel Pain. |
|
Scientific Title of Study
|
Efficacy Of Self Myofascial Release Technique On Pain And Function In Patients With
Plantar Fasciitis |
| Trial Acronym |
SMFR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anagha Kamble |
| Designation |
Ist year MPTh student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
11/12, Thube Park,Pune-411005 Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy,pune- 411005
Pune MAHARASHTRA 411005 India |
| Phone |
7875145235 |
| Fax |
|
| Email |
dranagha.k27@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanket Nagrale |
| Designation |
Assistant professor |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
11/12, Thube Park,Pune-411005 Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy,pune- 411005
Pune MAHARASHTRA 411005 India |
| Phone |
9545509677 |
| Fax |
|
| Email |
nagralesanket@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanket Nagrale |
| Designation |
Assistant professor |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
11/12, Thube Park,Pune-411005 Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy,pune- 411005
Pune MAHARASHTRA 411005 India |
| Phone |
9545509677 |
| Fax |
|
| Email |
nagralesanket@gmail.com |
|
|
Source of Monetary or Material Support
|
| 11/12 Thube Park,Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College Of Physiotherapy |
| Address |
11/12 Thube Park,Pune-411005 Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy,pune- 411005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anagha Kamble |
Tertiary healthcare centre in pune (Outpatient Department) |
11/12 Thube Park,Pune-411005 Sancheti Healthcare Academy, Sancheti Institute College of Physiotherapy,pune- 411005 Pune MAHARASHTRA |
7875145235
dranagha.k27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute Of Orthopaedics And Rehabilitation Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Plantar Fasciitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group(Exercise Group) |
US-duration-8 min.
intensity-0.8W/cm2
Intrinsic foot muscle strengthening
Static stretching for calf muscles -long sitting position with the use of towel- and for plantar fascia- sitting with the foot placed across the opposite knee, extend the forefoot by stabilizing the calcaneus.
3 sets of 30 sec.hold with 5 sec of rest period. Twice a day
|
| Intervention |
Experimental Group(Self MFR) |
US-duration-8 min.
intensity-0.8W/cm2
Intrinsic foot muscle strengthening
Self MFR for plantar fascia and calf muscles -Use of MFR tool for calf muscles in long sitting position and plantar fascia in seated position.
3 sets of 30 seconds at a cadence of one second per roll (travel the length of the muscle in one second). Twice a day.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Plantar medial heel pain.
Heel pain precipitated by a recent increase in weight-bearing activity.
Pain with palpation of the proximal insertion of the plantar fascia.
Positive windlass test.
Negative tarsal tunnel test.
VAS score ≥4.
duration of the condition <6 months. |
|
| ExclusionCriteria |
| Details |
recent lower limb injuries.
patients with RA
pregnancy
calcaneal stress fracture
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot Function Index |
1- after recruitment
2- after 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain- pressure pain threshold |
5 days 5 sessions |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
INTRODUCTION Plantar fasciitis (PF) is the most commonly reported cause of inferior heel pain. It has been estimated that it affects as much as 10% of the general population over the course of a lifetime. In fact, some authors have reported that PF accounts for between 8% and 15% of foot complaints in nonathletic and athletic populations. (1) It is estimated that 1 in 10 people will develop plantar fasciitis during their lifetime. (1)(4) It is more common in middle-aged obese females and young male athletes have a higher incidence in the athletic population. Heel spurs have commonly been implicated as a risk factor for PF. PF is usually unilateral, but up to 30% of cases have a bilateral presentation. The tightness of Achilles tendon is found in almost 80% of cases. The typical resolution time of plantar fasciitis is anywhere from 6 to 18 months and sometimes longer, which can lead to dissatisfaction of patient and physician. Most experts agree that early recognition and management of PF leads to the short course of treatment and a greater chance of success with conservative therapies. (2) Numerous interventions have been described for treatment of PF, which include: rest, heat, ice pack, non-steroidal anti-inflammatory drugs (NSAIDS), heel pads, magnetic insole, night splints, walking cast, taping, plantar and Achilles stretching, ultrasound, steroid injection, extracorporeal shock wave therapy, platelet-rich plasma injection, pulsed radiofrequency electromagnetic field therapy, and surgery. (2) Of these, the tissue-specific plantar fascia and calf stretching is more effective than low dose shock wave therapy in the acute phase of PF. And about local injections of steroids, there is no gold standard regarding the types and doses of local injection of corticosteroids. (2)(5) Myofascial release (MFR) is the application of a low load, long duration stretch to the myofascial complex, intended to restore optimal length, decrease pain, and improve function. It has been hypothesized that fascial restrictions in one part of the body cause undue tension in other parts of the body due to fascial continuity. This may result in stress on any structures that are enveloped, divided, or supported by fascia. (1) Self-myofascial release (SMFR) is a technique performed by the individual themselves rather than by a clinician, typically using a tool. (3) Myofascial practitioners believe that by restoring the length and health of the restricted connective tissue, pressure can be relieved on pain sensitive structures such as nerves and blood vessels. The objective of the study is to evaluate the efficacy of self-myofascial release on pain and function for the management of PF in comparison with a control group receiving static stretching. RESEARCH QUESTION Is self-myofascial release technique effective in improving pain and function in patients with plantar fasciitis?
HYPOTHESIS Self-myofascial release is not effective than static stretching in improving pain and foot function. -Self-myofascial release improves pain and foot function. -Self-myofascial release technique is better than static stretching. - Self-myofascial release, as well as static stretching, improves pain and foot function.
1. To check the efficacy of self-myofascial release technique in improving pain and function in patients with plantar fasciitis. OBJECTIVES 1. To see the effect of the self-myofascial release on pain and function in patients with plantar fasciitis. 2. To see the effect of static stretching in improving pain and function in patients with plantar fasciitis. 3. To compare the effects of two groups. STUDY DESIGN: Pre-test, post-test 2 group comparative study. STUDY POPULATIONS- Plantar fasciitis patients SAMPLE SIZE- 18 in each group SAMPLE SIZE CALCULATION- Formula SAMPLING TECHNIQUE- convenient sampling Inclusion criteria- 1. APTA guidelines - â Plantar medial heel pain â Heel pain precipitated by a recent increase in weight-bearing activity â Pain with palpation of the proximal insertion of the plantar fascia â Positive windlass test â Negative tarsal tunnel test 2. age group- 20-50 years 3. VAS score between= ≥4 4. duration of condition <6 months 1. Recent lower limb injuries. 2. Patients with RA 3. Pregnancy 4. Calcaneal stress fracture â— Foot Function Index â— Pressure pain threshold All the outcome measures will be measured by a blinded assessor pre-intervention and post-intervention (after 5 days). STUDY INSTRUMENT- PROCEDURE: Patients will be selected as per the inclusion criteria and will be informed about the study procedure and a written consent will be taken. ↓ Subjects will be allocated into two groups using computerized randomization. ↓ Baseline assessment will be taken along with the pain pressure threshold by a blinded assessor with foot function index scale to be filled by the patient. ↓ Treatment will be given to both groups of 5 sessions. and post-treatment assessment will be taken by the blinded assessor, with foot function index scale to be filled by the patient. ↓ Data analysis |