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CTRI Number  CTRI/2024/10/075814 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 24/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study between Effectiveness of Myofascial Release with Taping and Strengthening and Stretching exercises for Chronic Plantar Fasciitis 
Scientific Title of Study   Comparative study of effectiveness of myofascial release along with taping versus strengthening and stretching exercises of intrinsic foot muscles in chronic plantar fasciitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjana Thakkar 
Designation  MPT student 
Affiliation  Mahatma Gandhi university of medical sciences and technology, jaipur 
Address  Physiotherapy Ortho LAB, Department of Physiotherapy, Mahatma Gandhi Physiotherapy College, RIICO institutional area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8441088918  
Fax    
Email  sanjana2248@mgumst.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhusudan Tiwari 
Designation  Dean and principal 
Affiliation  Mahatma Gandhi university of medical sciences and technology, Jaipur 
Address  Dean and Principal Office, Department Of Physiotherapy, Mahatma Gandhi university of medical sciences and technology, RIICO institutional area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290964159  
Fax    
Email  principal.physiotherapy@mgumst.org  
 
Details of Contact Person
Public Query
 
Name  Dr Madhusudan Tiwari 
Designation  Dean and principal 
Affiliation  Mahatma Gandhi university of medical sciences and technology, Jaipur 
Address  Dean and Principal Office, Department Of Physiotherapy, Mahatma Gandhi university of medical sciences and technology, RIICO institutional area, Sitapura, Tonk Road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290964159  
Fax    
Email  principal.physiotherapy@mgumst.org  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy college, Mahatma Gandhi university of medical sciences and Technology, RIICO institutional area, Tonk Road, Sitapura, Jaipur, Rajasthan (India), 302022 
 
Primary Sponsor  
Name  Sanjana Thakkar 
Address  391 katewanagar new sanganer road, jaipur, rajasthan(india),302019 
Type of Sponsor  Other [self] 
 
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 
Dr Madhusudan Tiwari  Mahatma gandhi hospital, jaipur  Room no.14, physiotherapy OPD, basement.
Jaipur
RAJASTHAN 
8290964159

principal.physiotherapy@mgumst.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M722||Plantar fascial fibromatosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Myofascial release technique along with kinesio taping  1.All 20 patients will receive 20 minutes of moist heat therapy. 2.After moist heat treatment Myofascial Release should be done along plantar fascia and tendoachilles with application of lubricator. 3.After MFR taping should be done with supported arch. Foot should be placed in slight dorsiflexion. 4. Treatment duration will be 3 session per week for 2 weeks and taping in every alternate sessions. 
Comparator Agent  stretching and strengthening exercise of intrinsic foot muscles.  1. All 20 patients will receive 20 minutes of moist heat therapy. 2. After moist heat treatment various strengthening exercises are administered. These exercise are: a. Towel Curl Exercises b. Pebble Picking Exercises c. Figure of 8 Exercise d. Arch maintaining exercise e. Wobble Board Training 3. Treatment duration will be 3 sessions per week for 2 weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients will be included who are not older than 20-50 years.
Patients having complaints of heel pain for more than 2 weeks will be included.
Patients having a pain score of more than 3 and less than 8 in NPRS scale Evaluation.
Patients who were not receiving any other physiotherapy treatments were taken into consideration.
Patients willing to participate will be included.
Patients who can understand and obey instructions will be included.

 
 
ExclusionCriteria 
Details  Patients who have any history of trauma, fracture, or surgical procedure of the calcaneum, Tendo Achilles and foot will be excluded.
Patients suffering from any neurological conditions like Stroke, Parkinson and Multiple Sclerosis will be excluded.
Patients suffering from severe illnesses, such as cancer, inflammatory or rheumatic diseases, infections, and vascular disorders, will be excluded.
Patients receiving any other Physiotherapy treatment will be excluded.
Patients with any metabolic disease of bone and joints will be excluded.
Patients with carcinoma will be excluded
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Numerical pain rating scale
Foot Function Index 
2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Numerical pain rating scale
Foot Function Index 
2 weeks
2 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   10/11/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

GROUP A  This group will have n=20 Participants and will be given intervention of  Myofascial release technique along with kinesio taping.

All participants will receive 20 minutes of moist heat therapy while seated and reclining on a couch. The posterior aspect of the heel and calf region will be treated with moist heat therapy.

After moist heat treatment Myofascial Release should be done along plantar fascia and tendoachilles with application of lubricator.

After MFR taping should be done with supported arch. Foot should be placed in slight dorsiflexion. Small strips should be placed from the inside (medial) aspect of the foot, starting just behind the ball of the foot and extending towards the inside of the ankle.

These strips are aimed at supporting the arch.

The large strip is placed on the outside (lateral) aspect of the foot, starting just behind the ball of the foot and extending towards the outside of the ankle.

This strip helps support the lateral arch.

Another strip is placed from the outside of the foot, around the back of the heel, and towards the inside of the foot.

 

GROUP B This group will have n = 20 Participants and will be given the intervention of the physical therapy that includes stretching and strengthening exercise of intrinsic foot muscles.

All participants will receive 20 minutes of moist heat therapy while seated and reclining on a couch. The posterior aspect of the heel and calf region will be treated with moist heat therapy

After moist heat treatment various strengthening exercises are administered. These exercise are:

 

Towel Curl Exercises: patient is asked to curl towel with squeezing toes.

Pebble Picking Exercises:  patient is asked to pick pebbles from squeezed toes.

Figure of 8 Exercise: patient is asked to draw 8 from toes,

Arch maintaining exercise: patient is asked to curl the foot to form high arch.

Wobble Board Training: patient is asked to do alternate dorsiflexion-plantarflexion and alternate inversion and eversion.

 

All the exercises should be done with 10 repetitions each.

The Stretching Exercises administered are:

 

Tendoachilles Stretching: Patient is allowed to lie supine on couch with both knees extended. Therapist in walkstanding position places hand under heel slightly rises the leg and applies pressure while dorsiflexing foot with forearm. The pressure is maintained for 15 seconds.

 

We will guide patient to do Self calf stretching at home as exercises mention below:

With a wall

 

Step 1: Stand about an arm’s length in front of a wall. Place the right leg in front of the left. Reach both arms to the wall.

Step 2: Press the back (left) heel into the floor and straighten the back leg while keeping the front leg bent. Hold this position for 15 seconds.

Step 3: Repeat the stretch on the opposite side.

Without a wall

Step 1  Place the right leg in front of the left leg.

Step 2 Shift the body’s weight on to the front (right) leg, while keeping the back heel pressed into the floor. Hold this position for 15 seconds.

Step 3 Repeat the stretch on the opposite side.[11]

The exercises should be done with 10 repetitions

 
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