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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

  • Null hypothesis

Self-myofascial release is not effective than static stretching in improving pain and foot function.

  • Alternative hypothesis

-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.


AIM

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 -  

❏        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

 

2.      age group- 20-50 years

3.      VAS score between= ≥4

4.      duration of condition <6 months

 

Exclusion criteria-

1.      Recent lower limb injuries.

2.      Patients with RA

3.      Pregnancy

4.      Calcaneal stress fracture

 

OUTCOME MEASURES

●       Foot Function Index

●       Pressure pain threshold

All the outcome measures will be measured by a blinded assessor pre-intervention and post-intervention (after 5 days).

STUDY INSTRUMENT-

·    Algometer

 

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.

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Subjects will be allocated into two groups using computerized randomization.

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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.

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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.

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                                                                                               Data analysis

 
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