| CTRI Number |
CTRI/2025/08/092368 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| 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 THORACOLUMBAR FASCIA ACTIVATION AND PRESS UP EXERCISE ON PAIN AND RANGE OF MOTION IN MECHANICAL LOW BACK PAIN PATIENTS – A RANDOMIZED CLINICAL TRIAL’’ |
|
Scientific Title of Study
|
Comparative Efficacy of Thoracolumbar Fascia Activation and Press-Up Exercises on Pain Reduction and Lumbar Mobility in Mechanical Low Back Pain: A Randomized Clinical 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 |
GAGAN M S |
| Designation |
Physiotherapist |
| Affiliation |
cauvery college of physiotherapy mysuru |
| Address |
MPT Classroom 1, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
MPT Classroom 1, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
8549043887 |
| Fax |
|
| Email |
gaganm142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavan Kumar G |
| Designation |
Prinicipal |
| Affiliation |
cauvery college of physiotherapy mysuru |
| Address |
MPT Classroom 1, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
MPT Classroom 1, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9964964550 |
| Fax |
|
| Email |
principalphy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GAGAN M S |
| Designation |
physiotherapist |
| Affiliation |
cauvery college of physiotherapy mysuru |
| Address |
MPT Classroom 1, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
MPT Classroom 1, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028
Mysore
KARNATAKA
570028
India |
| Phone |
8549043887 |
| Fax |
|
| Email |
gaganm142@gmail.com |
|
|
Source of Monetary or Material Support
|
| cauvery college of physiotherapy mysuru |
|
|
Primary Sponsor
|
| Name |
cauvery college of physiotherapy |
| Address |
cauvery college of physiotherapy KBL layout near devegowda circle mysuru 570028 |
| Type of Sponsor |
Other [private college ] |
|
|
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 Srikanta K PT |
OPD cauvery college of physiotherapy |
Department of MSK, 1st floor, building 1, cauvery college of physiotherapy KBL layout near devegowda circle mysore 570028
Mysore
KARNATAKA |
8722725926
srikanta.kpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee cauvery heart and multispeciality hospital, mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mechanical low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
press up exercise |
press up exercise is given for 10 reps with 3 sets |
| Intervention |
thoracolumbar fascia activation via myofascial release and press up exercise |
Myofascial release is given for anterior and posterior portion of back for 15 minutes and press up exercise is given for 10 reps with 3 sets |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
i. Mechanical low back pain
ii. Age between 18 to 35
iii. Both male and females are included
iv. Back pain more than 2 weeks
v. NPRS between 3 to 6
vi. Reduced lumbar ROM
|
|
| ExclusionCriteria |
| Details |
i. Patient with abdominal hernia
ii. IVDP
iii. Pregnancy
iv. History of trauma at lumbar region
v. History of recent abdominal surgeries
vi. Person on pain medications
vii. Any rheumatic disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale |
before intervention and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| modified modified schober test |
before intervention & after intervention |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/08/2025 |
| 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="2"
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
|
This clinical trial will aim to investigate the treatment effect of TLF activation with press up exercise on pain and range of motion in mechanical low back pain. The outcome measures to be used will be NPRS and MMST. NPRS will be employed as a subjective measure to establish the severity of pain. The Modified Modified Schober Test will be utilized as an objective measure to evaluate the lumbar flexion and extension range of motion. In this study MFR will be applied to activate the thoracolumbar fascia in the anterior and posterior portions of the body along with press up exercise and this treatment will be administered for 15 minutes in a single session. Based on the anticipated findings integrating MFR with press up exercises will enhance pain relief and mobility. This study will support the use of MFR in clinical practice for managing mechanical low back pain. |