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CTRI Number  CTRI/2023/07/054640 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 01/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Giving manual therapy to heel to reduce pain and thickness beneath the foot 
Scientific Title of Study   Effectiveness of subtalar mobilization on plantar fascia thickness, pain and disability in subjects with plantar fasciitis: A Randomised Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khan Madiha Irfan 
Designation  Master in Musculoskeletal Physiotherapy 
Affiliation  MGM school of physiotherapy 
Address  Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Aurangabad
MAHARASHTRA
431001
India 
Phone  7798611703  
Fax    
Email  okmadiiha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rinkle Malani 
Designation  Director and Principle 
Affiliation  MGM school of physiotherapy 
Address  Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Aurangabad
MAHARASHTRA
431001
India 
Phone  9370312412  
Fax    
Email  dr.rinklemalani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Khan Madiha Irfan 
Designation  Master in Musculoskeletal Physiotherapy 
Affiliation  MGM school of physiotherapy 
Address  Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Aurangabad
MAHARASHTRA
431001
India 
Phone  7798611703  
Fax    
Email  okmadiiha@gmail.com  
 
Source of Monetary or Material Support  
2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra 431001 India 
 
Primary Sponsor  
Name  MGM School Of Phsyiotherapy 
Address  2nd floor MGM School of Physiotherapy C building N-6 Cidco, Aurangabad Maharashtra  
Type of Sponsor  Research institution and hospital 
 
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 
Khan Madiha Irfan  MGM School of Physiotherapy  Musculoskeletal department out patient department number 2 2nd floor MGM School of Physiotherapy C building N6 Cidco Aurangabad Maharashtra
Aurangabad
MAHARASHTRA 
7798611703

okmadiiha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee For Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Experimental and Conventional Therapy  2 week duration of intervention including Subtalar Mobilization, Cryotherapy, Plantar Fascia Stretching, Intrinsic Foot Muscles Strengthening, Taping  
Comparator Agent  Experimental Group  2 week duration of intervention including Subtalar Mobilization, Cryotherapy, Plantar Fascia Stretching, Intrinsic Foot Muscles Strengthening, Taping 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Willingness of the patient is taken into consideration.
2.Subjects who are diagnosed with plantar fasciitis.
3.Both male and female aged between 30-60 years.
4.Heel and foot pain.
5.Pain in the morning after taking few steps or after prolonged rest.
6.Subjects who have pain less than or equal to 5 on VAS.
 
 
ExclusionCriteria 
Details  1.Trauma, acute or chronic pathology.
2.Any systemic illness like rheumatism and pregnancy and malignancy.
3.A fracture below the knee , foot surgery.
4.Fat pat syndrome or tarsal tunnel syndrome.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
UltraSonography of plantar fascia thickness at pre and post intervention of 2 weeks  At Baseline and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Pain visual analogue scale(VAS)
Disability foot ankle disability index (FADI)
 
At Baselines 
 
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   N/A 
Date of First Enrollment (India)   15/07/2023 
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="0"
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  

Excessive stress on the plantar fascia causes plantar fasciitis and we aim reducing the pain for the same. This study introduces effectiveness of subtalar mobilization on plantar fasciitis to reduce pain and improve plantar fascia thickness using ultrasonographic measurements on Indian population. The use of ultrasound imaging will help us measure the plantar fascia thickness and diagnose it easily.

 
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