| 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
|
|
|
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
|
|
|
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 |