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CTRI Number  CTRI/2024/10/075878 [Registered on: 25/10/2024] 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   Comparison between Instrument assisted soft tissue mobilization and Stretching in patients of plantar fasciitis for pain, function and activities of daily living  
Scientific Title of Study   To Compare The Effectiveness of IASTM (Instrument Assisted Soft Tissue Mobilization)along with Conventional Physiotherapy Versus Stretching along with Conventional Physiotherapy on Pain,Function and Activities Of Daily Living in Plantar Fasciitis Patients: A Comparative study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Jadon  
Designation  MPT student  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9638178232  
Fax    
Email  priyanka2010@mgumst.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemendra Kumar Sharma  
Designation  Associate Professor  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Orthopaedics physiotherapy lab, Mahatma Gandhi Physiotherapy College,Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9460888177  
Fax    
Email  drhksharma@mgumst.org  
 
Details of Contact Person
Public Query
 
Name  Dr Hemendra Kumar Sharma  
Designation  Associate Professor  
Affiliation  Mahatma Gandhi University of Medical Sciences and Technology  
Address  Orthopaedics physiotherapy lab, Mahatma Gandhi Physiotherapy College,Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, Sitapura, Tonk road, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9460888177  
Fax    
Email  drhksharma@mgumst.org  
 
Source of Monetary or Material Support  
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO institutional area, sitapura, tonk road, Jaipur, Rajasthan (India),302022 
 
Primary Sponsor  
Name  Priyanka Jadon  
Address  F-48, Jagdamba Nagar F,near Shiv Shakti Mandir, Dhawas, Jaipur, Rajasthan,India,302021 
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 Hemendra Kumar Sharma   Mahatma Gandhi Hospital  Room number 14, Physiotherapy Out Patient Department, Basement.
Jaipur
RAJASTHAN 
9460888177

drhksharma@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  Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy  This will be a 2 weeks study.6 days /week,the study will run.The patient will do 5-minute warm-up exercise to warm-up the tissues(Prior to IASTM ).Each participant will then receive 2 minutes of IASTM (Instrument assisted soft tissue mobilization) over each area of restriction using Edge mobility tool after scanning the area. Cream/lubricant will be applied on calf and plantar region of foot as it will assist in reducing friction on skin and then the Edge mobility tool will be used in mobilizing the tissues on triceps surae (gastrocnemius and soleus) and plantar region of foot by pressing the tool along the leg and the foot. Ice will be offered after each session for pain management (as needed). Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed. The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each. 
Comparator Agent  Stretching along with conventional physiotherapy  For 2 weeks, 6 days/week this will go on. Gastrocnemius muscle stretch: 3 repetitions for 30 sec hold . The patient will lie prone with the feet extended off at the end of the examination table so that the knee remains straight as the examiner applies firm pressure to the ball of the foot to take up slack while dorsiflexing the foot at the ankle. Soleus muscle stretch: 3 repetitions for 30 sec hold . The patient will lie prone with the knee flexed and the ankle passively dorsiflexed. Increased pressure is gradually applied to dorsiflex the foot fully. The stretching for each muscle gastrocnemius and soleus will be held with moderate pressure to feel stretch pressure without causing any stretch pain. Plantar Fascia Stretch: 3 repetitions for 30 sec hold Position of the subject will be sitting with affected leg cross over the contralateral leg .Technique is while using the hand on the affected side, the fingers will be placed across the base of the toes on the bottom of the foot and pull the toes back toward the shin until they feel a stretch in the arch of the foot. This will confirm that the stretching is correct by palpating the tension in the plantar fascia with the contralateral hand while performing the stretching. Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed. The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Males and females between age group 30-50 years,
Subjects having pain for more than 3 months over the heel,
Pain with first steps upon walking (greater than or equal to 3 on a 0 to 10 VAS scale),
Pain that is worse in the morning during the initial steps, but which decreases after walking continues. 
 
ExclusionCriteria 
Details  Persons who are undergoing corticosteroids injection, receiving plantar non- steroidal anti- inflammatory medications within the previous 3 week,
Any known radiating pain (lower limb),
Any other lower extremity injury during the previous 6 months,
Currently engaging in any Physical therapy within previous 1 week ,
Calcaneal fracture 
 
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 
Visual analogue scale
Foot and Ankle Ability Measure - Activities of Daily Living Subscale
Foot Function Index - Pain Subscale 
2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS)  1 week 
 
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 Applicable 
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  
40 participants will be randomly divided into two groups. In Group A: All 20 patients will be treated with Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy and in Group B: All 20 patients will be treated with stretching along with conventional physiotherapy. All participants will be assessed for plantar fasciitis pain, function and activities of daily living with  a Visual Analogue Scale (VAS) , Foot Function Index Pain Subscale (FFI) and the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale  . The study will be of 2 weeks. 6 sessions will be taken in a week for both the groups. All variables will be measured at baseline, at the end of 1st week and at the end of 2nd week of the study.
.
Group A (Instrument-assisted soft tissue mobilization (IASTM) along with conventional physiotherapy)

The patient will do 5-minute warm-up exercise to warm-up the tissues(Prior to IASTM ).Each participant will then receive 2 minutes of IASTM (Instrument assisted soft tissue mobilization) over each area of restriction using Edge mobility tool after scanning the area. Cream/lubricant will be applied on calf and plantar region of foot as it will assist in reducing friction on skin and then the Edge mobility tool will be used in mobilizing the tissues on triceps surae (gastrocnemius and soleus) and plantar region of foot by pressing the tool along the leg and the foot. Ice will be offered after each session for pain management (as needed) .

Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.

The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each.

Group B (Stretching along with conventional physiotherapy)

 Gastrocnemius muscle stretch: 3 repetitions for 30 sec hold 
The patient will lie prone with the feet extended off at the end of the examination table so that the knee remains straight as the examiner applies firm pressure to the ball of the foot to take up slack while dorsiflexing the foot at the ankle.

 Soleus muscle stretch: 3 repetitions for 30 sec hold 
The patient will lie prone with the knee flexed and the ankle passively dorsiflexed. Increased pressure is gradually applied to dorsiflex the foot fully.
The stretching for each muscle gastrocnemius and soleus will be held with moderate pressure to feel stretch pressure without causing any stretch pain.

Plantar Fascia Stretch: 3 repetitions for 30 sec hold 
Position of the subject will be sitting with affected leg cross over the contralateral leg .Technique is while using the hand on the affected side, the fingers will be placed across the base of the toes on the bottom of the foot and pull the toes back toward the shin until they feel a stretch in the arch of the foot. This will confirm that the stretching is correct by palpating the tension in the plantar fascia with the contralateral hand while performing the stretching.

Ultrasound with frequency of 1 MHz with continuous current whose intensity will be 1.8 W/cm2.Time period of 8 minutes will be followed.

The strengthening exercise program will consist of a toe curl exercise, ankle evertor exercise, ankle invertor exercise, and heel raise exercise, 15-20 reps each.
 
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