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CTRI Number  CTRI/2024/02/062311 [Registered on: 06/02/2024] Trial Registered Prospectively
Last Modified On: 22/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Compare using specific tool for soft tissue versus specific exercise along with heat on pain and ankle movement in individuals with heel pain 
Scientific Title of Study   Comparison of Immediate Effect of Instrument Assisted Soft Tissue Mobilization Versus Muscle Energy Technique along with Hot pack on Pain and Range of Motion in Individuals with Heel pain. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Kubal 
Designation  Assistant Professor (PT) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building) Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Kubal 
Designation  Assistant Professor (PT) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8691948255  
Fax    
Email  swatikubal@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Mahek Lokwani 
Designation  Post Graduate Student (Physiotherapist) 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400008
India 
Phone  08275559992  
Fax    
Email  maheklokwani92@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Swati Kubal  P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital  Room No. 2, OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA 		 8691948255

swatikubal@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Instrument Assisted Soft Tissue Mobilization (IASTM)   1.IASTM-IASTM will be given with M2T blade. Participants will be instructed to lie prone with their feet off the end of table. Lubricant or moisturizer will be applied to the treating part. A sweeping stroke will be used to scan the calf muscles for adhesions. The instrument will be at 30 to 45 degree angle while the moderate pressure is maintained. IASTM then will be performed in alternating proximal and distal directions parallel to muscle fibres for 5mins. The pressure of technique on the calf muscle will be modified according to the patient response. Total duration will be approximately 10 minutes.  
Comparator Agent  2. Muscle Energy Technique along with Hot pack.  Firstly, hot pack will be given over the affected area for 20mins followed by MET for gastrocnemius-soleus muscle. For MET of gastrocnemius-soleus muscle, patient will be asked to lie supine. For gastrocnemius the patient knee will be extended. The patient‟s ankle will be dorsiflexed and from the point of barrier, patient will be instructed to plantar flex and the movement will be resisted by the therapist. Patient will be asked to isometrically contract for 10secs. Following the contraction, therapist goes into new range of dorsiflexion to initiate local tissue stretch. Again, isometric contraction of gastrocnemius will be performed and same procedure will be repeated thrice. Similarly, this technique of isometric contraction will be done for soleus muscle with the knee flexed. Total duration will be approximately 25 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1. Individuals in the age group of 18-65 years.
2. Both genders.
3. Individuals with unilateral heel pain with tight gastrocnemius-soleus muscle.
4. Individuals with a score of less than 7 on Visual Analogue Scale (VAS).
5. Individuals willing to participate in study. 
 
ExclusionCriteria 
Details  1. Individual with history of acute ankle sprain.
2. Individual with recent traumatic history to lower limb.
3. Individual with neurological condition.
4. Individual with vascular disorders.
5. Individuals with comorbidities like diabetes, hypertension. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinometer smartphone App for passive ROM of ankle dorsiflexion.  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Clinometer smartphone App for passive ROM of ankle dorsiflexion.
 		 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial
Modification(s)  		 N/A 
Date of First Enrollment (India)   12/02/2024 
Date of Study Completion (India) 20/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/08/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 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)  

The aim of the present study was to compare the Immediate Effect of Instrument Assisted Soft Tissue Mobilization versus Muscle Energy Technique along with Hot pack on Pain and Range of motion in Individuals with Heel pain.

Participants were recruited in the study depending on selection criteria and Informed consent was taken.

 

Sixty participants were divided into two groups: 30 in IASTM Group (Group A) and 30 in MET along with Hot pack (Group B) with chit method. Outcomes measures for both the group were VAS for heel pain and ROM for ankle dorsiflexion, pre and post session. Data collection was done and appropriate statistical analyses were conducted for the obtained data. 

 

The study concluded that both IASTM and MET combined with a hot pack were effective in reducing pain and improving ROM in individuals with heel pain. However, IASTM demonstrated a greater immediate effect compared to MET along with hot pack in individuals with heel pain.

 

 


 
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