CTRI Number |
CTRI/2025/03/083119 [Registered on: 21/03/2025] Trial Registered Prospectively |
Last Modified On: |
21/03/2025 |
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
|
Comparison of two muscle releasing technique in plantar fasciitis
|
Scientific Title of Study
|
Comparative Effect of Muscle Energy Technique and Positional Release Technique in 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 |
Shivani Grover |
Designation |
Student |
Affiliation |
Department of physiotherapy |
Address |
Department of physiotherapy , Guru Jambheshwar University of Science and Technology
Hisar - 125001, Haryana, India
Hisar HARYANA 125001 India |
Phone |
9729591928 |
Fax |
|
Email |
grovershivani123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Alka Pawalia |
Designation |
Assistant Professor |
Affiliation |
Department of physiotherapy |
Address |
Department of physiotherapy , Guru Jambheshwar University of Science and Technology
Hisar - 125001, Haryana, India
Hisar HARYANA 125001 India |
Phone |
9468349944 |
Fax |
|
Email |
alkapawalia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Shivani Grover |
Designation |
Student |
Affiliation |
Department of physiotherapy |
Address |
Department of physiotherapy , Guru Jambheshwar University of Science and Technology
Hisar - 125001, Haryana, India
Hisar HARYANA 125001 India |
Phone |
9729591928 |
Fax |
|
Email |
grovershivani123@gmail.com |
|
Source of Monetary or Material Support
|
Shivani Grover MPT student Department of physiotherapy Guru Jambheshwar University of Science & Technology, Hisar 125001 Haryana India |
|
Primary Sponsor
|
Name |
Department of physiotherapy |
Address |
Department of physiotherapy , Guru Jambheshwar University of Science and Technology
Hisar - 125001, Haryana, India |
Type of Sponsor |
Research institution |
|
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 |
Alka Pawalia |
Guru Jambheshwar University |
Room No. 4 Physiotherapy OPD, Department of Physiotherapy Guru Jambheshwar University of Science & Technology hisar haryana Hisar HARYANA |
9468349944
alkapawalia@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethics committee of GJUST |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group A |
This Group will receive Muscle Energy Technique (MET) and Ultrasound Therapy, followed by a exercise program.Treatment will consist of a 3-week program. For the initial 2 weeks, session will be administered 5 days a week. In a final week, treatment will be provided in 2 sessions. |
Intervention |
Group B |
Participants in Group B will receive Positional Release Technique (PRT) and Ultrasound Therapy. followed by a exercise program.Treatment will consist of a 3-week program. For the initial 2 weeks, session will be administered 5 days a week. In a final week, treatment will be provided in 2 sessions. |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Age group- 25-60 years.
Male and female
Presence of plantar fasciitis (Symptoms more than 6 weeks)
|
|
ExclusionCriteria |
Details |
Ankle Fracture
Diabetic neuropathy
Metal implants around ankle
Infective condition of foot, tumor, dermatitis, acute sepsis.
Recent Surgery
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1: Pain Intensity – Measured using the Visual Analog Scale (VAS).
2: Range of Motion (ROM) – Measured for:
Plantar Flexion
Dorsiflexion
Inversion
Eversion |
Treatment will consist of a 3-week program. For the initial 2 weeks, session will be administered 5 days a week. In a final week, treatment will be provided in 2 sessions. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1: Functional Ability – Assessed using the Foot Function Index (FFI).
2: Activity of Daily Living (ADL) – Evaluated using the Foot and Ankle Ability Measure (FAAM). |
Treatment will consist of a 3-week program. For the initial 2 weeks, session will be administered 5 days a week. In a final week, treatment will be provided in 2 sessions. |
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/04/2025 |
Date of Study Completion (India) |
08/07/2025 |
Date of First Enrollment (Global) |
02/04/2025 |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
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
|
Study Procedure: Subjects will be selected according to the inclusion and exclusion criteria. The subjects will be divided into two groups: Group A and Group B. The ankle goniometry, VAS, FFI and FAAM scores will be recorded at baseline and after the last treatment. Treatment will consist of a 3-week program. For the initial 2 weeks, session will be administered 5 days a week. In a final week, treatment will be provided in 2 sessions. Intervention: Group A Participants in Group A will receive Muscle Energy Technique (MET) and Ultrasound Therapy, followed by a exercise program. · Muscle Energy Technique (MET): For gastrocnemius muscle, the subject will lie in a supine position with the knee fully extended, and the therapist will stand on the affected side. The therapist will dorsiflex the subject’s ankle joint until resistance is felt. The subject will be asked to hold this position and exert 20% of their force towards plantar flexion for 5-7 seconds. Then, the resistance will be released, and the subject will relax for 5 seconds. The therapist will passively dorsiflex the ankle joint to a new barrier. A set of 5 repetitions will be given. For soleus muscle, the subject will be in a supine position, keeping the knee slightly flexed, and the therapist will stand on the affected side in a walking position. The subject’s ankle joint will be dorsiflexed until resistance is felt, and they will be asked to hold this position and exert 20% of their force towards plantar flexion for a period of 5 to 7 seconds. Then, the resistance will be released, and relaxation for a period of 5 seconds will be given, during which the ankle will be passively dorsiflexed to a new barrier. A set of 5 repetitions will be performed. · Ultrasound Therapy: US therapy will be applied using the following parameters: continuous mode, base frequency of 1 MHz to produce a deeper penetration, power of 2 W/cm2 into the areas of the painful heel, insertion of the plantar fascia on the medial calcaneal area, and the myofascial junction at the dorsum of the heel for 5 minutes using an ultrasound gel. · Exercises: 1. Stretching of the hamstrings and ankle plantar flexors (straight leg raise in the supine position). 2.Stretching of Calf muscles: The patient leaned forward in the standing position with the affected foot farther away from the wall, while keeping the heel on the floor; the soleus muscle was emphasized with the knee flexed and the gastrocnemius muscle with the knee extended. 3.Stretching of the plantar fascia: in the sitting position, the patient crossed the affected foot over the contralateral thigh and performed passive extension of the metatarsophalangeal joints. Group B Participants in Group B will receive Positional Release Technique (PRT) and Ultrasound Therapy. followed by a exercise program. - Positional Release Technique (PRT): Group PRT will receive positional release technique. The subjects will be made to lie in a supine position with the affected limb out of the plinth, and then slight mechanical pressure will be put on the tender point with one fingertip to determine the tenderness. The foot will then be positioned into complete plantar flexion and gently fine-tuned by rotation until there is a reduction in tender point by at least 70%, and this position will be held for 90 seconds with 3 repetitions.
Group A | Group B | MET for the gastrocnemius and soleus muscles will be provided for a set of 5 repetitions, using ultrasound therapy. | PRT will be administered for 90 seconds with 3 repetitions, using ultrasound therapy. | Self-stretching will be taught for the plantar fascia, hamstrings, ankle plantar flexors, and calf muscles with 3 repetitions and a 20-second hold. | Self-stretching will be taught for the plantar fascia, hamstrings, ankle plantar flexors, and calf muscles with 3 repetitions and a 20-second hold | |