| CTRI Number |
CTRI/2024/08/072330 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| 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
|
To Compare the effects of two treatment on patients with Plantar Fasciitis. involvjoint mobilization and stretching and the other involves strength training and stretching, to see which one better reduces pain and improve movement. |
|
Scientific Title of Study
|
To Compare The Effect Of Subtalar Mobilization Along With Stretching Versus High Load Strength Training With Stretching To Decrease Pain And Improve Range Of Motion In Patient With Plantar Fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purva Pant |
| Designation |
Post Graduate student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and allied Health Sciences |
| Address |
Room no. 4, Department of physiotherapy, North Block Basement, Shri Mahant Indriresh Hospital, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7302113871 |
| Fax |
|
| Email |
purvapant1898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tabassum Azmi |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and allied Health Sciences |
| Address |
Room no. 4, Department of physiotherapy, North Block Basement, Shri Mahant Indriresh Hospital, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Purva Pant |
| Designation |
Post Graduate student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and allied Health Sciences |
| Address |
Room no. 4, Department of physiotherapy, North Block Basement, Shri Mahant Indriresh Hospital, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7302113871 |
| Fax |
|
| Email |
purvapant1898@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Paramedical and allied Health Sciences, Pathribagh, Dehradun, Uttrakhand, 248001 |
|
|
Primary Sponsor
|
| Name |
Purva Pant |
| Address |
Room no.4, physiotherapy department, Shri Guru Ram Rai University, School of Paramedical and allied Health Sciences, Pathribag, Dehradun, Uttranchal, 248001 |
| Type of Sponsor |
Other [(Self )] |
|
|
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 |
| Dr Tabassum Azmi |
Shri Mahant Indriresh Hospital |
Department of physiotherapy, North Block Basement, Shri Mahant Indriresh Hospital, Dehradun,
Dehradun
UTTARANCHAL |
9340473424
drtabassumazm22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee(IEC) Shri Guru Ram Rai Institute of Medical and Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Stretching and High Load Strength Training |
Stretching exercise will be given for 6 days a week for 8 weeks along with High load strength training for 4 days a week for 8 weeks |
| Intervention |
Stretching and Subtalar Joint Mobilization |
Plantar fascia specific stretching exercise will be given for 6 days a week for 8 weeks along with subtalar joint mobilization for 6 days a week for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from heel pain for at least 3 months prior to enrollment or aged upto (18) to (45) years. Both (Male) and (female) |
|
| ExclusionCriteria |
| Details |
No history of prior heel surgery, prior heel fractures, corticosteroid injection for plantar fasciitis within the previous 6 months, any red flag for mobilization like tumour, fractures, rheumatoid arthritis and osteoporosis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale(NPRS) |
1st day, 29th day, 58th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| foot Function Index |
1st day, 29th day, 58th day |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
25/08/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A specific rehabilitation program, including stretching exercises, high load strength training exercise and mobilization exercise can effectively improve range of motion of ankle joint and decrease pain. It also strengthen the foot muscles. This research will be done on 36 patients. These 36 patients are divided into 2 groups, A and B, group A is consist of subtalar joint mobilization with stretching and treatment will be given for 6 days a week for 8 weeks, Group B is consist of High Load Strength Training with Stretching for 4 days a week for 8 weeks. |