CTRI Number |
CTRI/2023/06/054238 [Registered on: 21/06/2023] Trial Registered Prospectively |
Last Modified On: |
28/07/2025 |
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
|
Efficacy of Instrument Assisted Soft Tissue Mobilization in Plantar Fasciitis |
Scientific Title of Study
|
Efficacy of Instrument Assisted Soft Tissue Mobilization in patients with Plantar Fasciitis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Varun Singh |
Designation |
Assistant Professor |
Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
Hisar HARYANA 125001 India |
Phone |
9802991664 |
Fax |
|
Email |
dr.varunpoonia@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Varun Singh |
Designation |
Assistant Professor |
Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
Hisar HARYANA 125001 India |
Phone |
9802991664 |
Fax |
|
Email |
dr.varunpoonia@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Varun Singh |
Designation |
Assistant Professor |
Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
Hisar HARYANA 125001 India |
Phone |
9802991664 |
Fax |
|
Email |
dr.varunpoonia@gmail.com |
|
Source of Monetary or Material Support
|
Deeksha (MPT) Department of Physiotherapy Guru Jambheshwar University of
Science and Technology New Delhi-Sirsa Highway Hisar-125001 Haryana
|
|
Primary Sponsor
|
Name |
Guru Jambheshwar University of Science and Technology |
Address |
New Delhi-Sirsa Highway Hisar-125001 Haryana India |
Type of Sponsor |
Other [Government University] |
|
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 |
Deeksha |
Guru Jambeshwar University of Science and Technology |
Room No.: 109, Research Lab, Department of Physiotherapy Hisar HARYANA |
8168087979
deekshamehta22@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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 |
Comparator Agent |
Exercise |
Achilles tendon stretch (5 minutes); Calf stretch (5 minutes); Plantar fascia self-stretch (10 minutes); Ball rolling exercise (2 minutes); Plantar aponeurosis loading (2 minutes) for 6 sessions carried out for 2 consecutive weeks. |
Intervention |
IASTM |
Warm up (10-12 minutes); IASTM (40-120 seconds); Stretching (3 minutes); Strengthening, high repetitions low dose exercises (5 minutes); Cryotherapy (10-20 minutes) for 6 sessions carried out over 2 consecutive weeks. |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Patients that shows tenderness on palpation at origin of plantar fascia on medial calcaneal tubercle, confirming the diagnosis of proximal plantar fasciitis.
Morning pain while taking first step or after prolonged rest.
A reduction in pain following light activities |
|
ExclusionCriteria |
Details |
Undergone prior orthopedic surgery
Cognitive and perceptual disorder
Subjects had chronic venous insufficiency
Pregnant women
Psychiatric disorder
Uncooperative patient
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain
Disability |
all outcome measured before the start of
intervention i.e. at baseline & after the
completion of treatment i.e. at 2 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
03/07/2023 |
Date of Study Completion (India) |
22/05/2025 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="5" 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
Modification(s)
|
A randomized control study on population with plantar fasciitis. Heel pain is affecting around 10-15% of total population. Mostly alters the persons with sedentary lifestyle and also affects athletes. Different types of intervention plasma rich therapy, extracorporeal shock wave therapy, corticosteroids, surgical procedure and physiotherapy for management of plantar fasciitis. Surgical intervention results in complications and researches don’t show any firm results. Manual therapy can be an effective method in treating plantar fasciitis. So this study was planned to evaluate the efficacy of instrument assisted soft tissue mobilization in patients with plantar fasciitis. Subjects will be screened for plantar fasciitis using inclusion criteria. Informed consent will be taken for participation in study. Participants will be allocated in two groups. Treatment protocol for group A – Warm up(10-12 min);IASTM,done at 30-60 degrees angle for 40-120 seconds; Stretching 3 repetitions for 30 seconds; Strengthening, high repetitions low dose exercises; Cryotherapy, 10-20 minutes. Treatment protocol for group B – Achilles tendon stretch (30 second hold -3 repetitions);Calf stretch (30 second hold – 3 repetitions); Plantar fascia self stretch (10 second hold ,10 repetitions at a time ,3 sets of 10 repetitions per day); Ball rolling exercise (rolling for 2 minutes); Plantar aponeurosis loading (10 repetitions with 2 second hold). Treatments will be given for 2 weeks with 3 sessions in a week. Data would be recorded at day 0 then at completion of treatment of 2 weeks using VAS and FFI for pain and disability respectively. The VAS and FFI mean scores at the outset did not differ significantly between the study group and the control group. However, the post-intervention means of the VAS and FFI in the experimental group are significantly different from those of the control group. Reductions in VAS and FFI scores of 60.95 and 57.34 per cent, respectively, were seen in the treatment group, while reductions of 32.5 and 31.85 percent were seen in the control group. The MCID for VAS is 2.0; therefore, a result of 4.1 in the experimental group and 2.0 in the control group is clinically significant. The mean change for VAS in the experimental group is 4.1, and that in the control group is 2.0. When compared to the MCID for FFI, which is 12, the results seen in both the experimental and control groups are clinically significant, with the mean change for FFI in the experimental group being 48.32 and that in the control group being 26.44. The IASTM group, on the other hand, saw larger improvements in the mean of both end variables compared to the exercise group. The present study set a time constraint of two weeks, and previous research has shown that PF healing will take less time using IASTM than it does spontaneously. So, in the IASTM group, after 6 sessions of therapy, there was a statistically and clinically significant improvement in both measures, while in the control group, the result for VAS is statistically significant only, but for FFI, there is a statistically and clinically significant improvement. The mean change in VAS and FFI scores is larger in the IASTM group compared to the exercise group. It follows that IASTM may represent a personal preference in lieu of more standard medical care. However, further study may be required to ascertain whether or not the enhancement will endure for a significant amount of time. |