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
|
|
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
|
|
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. |