| CTRI Number |
CTRI/2024/12/077723 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Myofascial release for low back pain |
|
Scientific Title of Study
|
Effect of 3-dimensional Myofascial Release Therapy on pain and range of motion in subjects with non-specific low back pain-A Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rani Hubli |
| Designation |
Post graduate |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no. 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6362377204 |
| Fax |
|
| Email |
ranihubli2411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Hungund |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8310725829 |
| Fax |
|
| Email |
apeksha_hungund@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rani Hubli |
| Designation |
Post Graduate |
| Affiliation |
KAHER Institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
6362377204 |
| Fax |
|
| Email |
ranihubli2411@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore hospital and research center, Nehru Nagar, Belagavi -590010 India |
|
|
Primary Sponsor
|
| Name |
KAHER institute of physiotherapy |
| Address |
KAHER institute of physiotherapy, JNMC campus, Nehru Nagar, Belagavi- 590010 India |
| 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 |
| Rani Hubli |
KAHER institute of physiotherapy |
Advanced Physiotherapy center, room no, 39 department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka 590010 India
Belgaum
KARNATAKA |
6362377204
ranihubli2411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KAHER institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Non-specific low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3-Dimensional Myofascial Release Group
|
The subjects will be given 3-dimensional myofascial release for 2 weeks 6 times and the individual will perform active forward flexion of trunk, trunk rotation and hyperextension of trunk at the same time. To release the restrictions through the entire range of movement, the patient is in sitting position on the treatment table. Prior to which interferential therapy and core stability exercises will be given. |
| Comparator Agent |
Controlled Group |
Interferential Therapy and core stability and stretching exercises will be given for 2 weeks 6 times. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals of age group 20 to 50 years suffering from non-specific low back pain with pain intensity 4 to 6 on visual analogue scale and hamstring tightness of more than 23.4 degree on active knee extension test (AKET) |
|
| ExclusionCriteria |
| Details |
Individuals with malignant tumors, spinal cord infections or fractures, neurological symptoms such as radiating pain, parasthesia and muscle paralysis, inflammatory disease such as spinal tuberculosis or rheumatism, individuals who have undergone orthopedic surgery on lower back, pelvis or hips, muscle rupture and pregnant women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Flexicurve for lumbar index
2. Modified modified schober’s test for lumbar range of motion
3. Visual analogue scale for pain intensity
4. OSWESTRY disability index |
All the outcome measures will be measured pre (Day 1) and post intervention (Day 6) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
05/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The most prevalent cause for non-specific low back pain is the structural changes in muscles and bad posture which results in imbalance of thoraco-lumbar muscles causing tightness and weakness in the surrounding muscles. It was hypothesized that there will be difference in the effect of 3-Dimensional Myofascial Release Therapy with conventional physiotherapy with respect to pain, lumbar ROM, lumbar lordosis and functional disability using Visual analogue scale (VAS), Modified-Modified Schober’s test, Flexicurve and OSWESTRY questionnaire respectively. The study will include total of 36 participants with non-specific low back pain in age group of 20 to 50years. Outcome measures include flexicurve for assessing lumbar lordosis, modified-modified Schober’s test for lumbar ROM and OSWESTRY questionnaire for functional disability. The study is randomized controlled trial. Controlled group will receive 6 sessions of conventional physiotherapy and intervention group will receive 6 sessions of conventional physiotherapy along with 3-Dimensional Myofascial Release Therapy. |