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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  
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 
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  
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 
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.

 
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