| CTRI Number |
CTRI/2024/11/076245 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| 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
|
Comparing proprioceptive neuromuscular facilitation stretching and foam rolling exercise on iliotibial band tightness in young adults with mechanical low back pain |
|
Scientific Title of Study
|
Effect of Proprioceptic neuromuscular facilitation stretching and foam rolling exercise on iliotibial band tightness with mechanical low back pain among young adults |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Athulya KV |
| Designation |
Post graduate student |
| Affiliation |
Yenapoya institute of physiotherapy college |
| Address |
Yenepoya naringana campus, physiotherapy department, deralakatte, mangalore, Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8086479600 |
| Fax |
|
| Email |
athulyakvclt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Muhammad jabir CT |
| Designation |
Assistant professor |
| Affiliation |
Yenapoya institute of physiotherapy college |
| Address |
Yenepoya physiotherapy college, naringana, physiotherapy department, deralakatte, mangalore, Karnataka
Yenepoya physiotherapy college, naringana, deralakatte, mangalore- 575018 Karnataka
india
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8792161702 |
| Fax |
|
| Email |
jabirmeppayur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athulya KV |
| Designation |
Post graduate student |
| Affiliation |
Yenapoya institute of physiotherapy college |
| Address |
Yenepoya naringana campus, physiotherapy department, deralakatte, mangalore, Karnataka
KARNATAKA
575018
India |
| Phone |
8086479600 |
| Fax |
|
| Email |
athulyakvclt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy college,deralakatte,mangalore - 575018
Karnataka |
|
|
Primary Sponsor
|
| Name |
Athulya kv |
| Address |
Yenepoya physiotherapy college, naringana, deralakatte,mangalore-575018 Karnataka |
| 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 Mohammad Jabir C T |
Yenepoya university |
7th floor, wing D , physiotherapy OPD, Deralakatte, Mangalore, karnataka Pincode-575018
Dakshina Kannada
KARNATAKA |
08792161702
jabirmeppayur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foam rolling exercise |
Foam rolling exercise in side lying for 3 times per week for 4 weeks |
| Intervention |
PNF stretching exercise |
PNF stretching exercise in side lying for 3 times per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
-Participant with age group of 18 to 25years
- Both males and females are included in this study
-Participant with mechanical low back pain with ITB tightness |
|
| ExclusionCriteria |
| Details |
-Low back pain with any specific traumatic or
-pathologicalconditions
-Decrease range of motion due to stiffness in knee and ankle.
-Recent fracture of lower extremity
-Participant with history of surgery on lower back or lower limb |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ober’s test
Goniometer |
Baseline(at 0th week)
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
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="1"
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
|
study summary:
Title: Effect of Proprioceptic neuromuscular facilitation stretching and Foam rolling exercise on iliotibial band tightness with mechanical low back pain among young adults
Objective: The study aimed to compare the effectiveness of PNF stretching and Foam rolling exercise on ITB tightness with mechanical low back pain among young adults
Methods: -Design- Quasi experimental study
-Participants- Iliotibial band tightness with mechanical low back pain among young adults. Subjects were randomly assigned to two groups: an experimental group and a control group.
-Intervention: The experimental group performed PNF stretching while control group performed foam rolling exercise
-Duration: Typically, the intervention lasted for 4 weeks,with regular sessions (e.g., 3 times per week)
-Outcome measures: iliotibial band muscle tightness was assessed using ober’s test
|