| CTRI Number |
CTRI/2026/01/100913 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/12/2025 |
| 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 check which of the two treatment technique is beneficial to manage lower back pain |
|
Scientific Title of Study
|
THE EFFECTIVENESS OF SELF MYOFASCIAL RELEASE VERSUS MAITLAND MOBILIZATION TECHNIQUE ALONG WITH MC GILLS BIG 3 EXERCISES AMONG NON SPECIFIC 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 |
Nishka S Bolar |
| Designation |
Post Graduate Student |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Tejasvini Physiotherapy College
(A unit of Amar shanth charitable Trust) Opposite Anantha Padmanbha temple, Kudupu, Mangalore 575028
Dakshina Kannada KARNATAKA 575028 India |
| Phone |
9591379450 |
| Fax |
|
| Email |
nishkabolar20@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nishka S Bolar |
| Designation |
Post Graduate Student |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Physiothereapy OPD
Tejasvini Physiotherapy College
(A unit of Amar shanth charitable Trust)
Opposite Anantha Padmanbha temple, Kudupu, Mangalore 575028
Dakshina Kannada KARNATAKA 575028 India |
| Phone |
9591379450 |
| Fax |
|
| Email |
nishkabolar20@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nishka S Bolar |
| Designation |
Post Graduate Student |
| Affiliation |
Tejasvini Physiotherapy College |
| Address |
Physiotherapy OPD
Tejasvini Physiotherapy College
(A unit of Amar shanth charitable Trust) Opposite Anantha Padmanbha temple, Kudupu, Mangalore 575028
Dakshina Kannada KARNATAKA 575028 India |
| Phone |
9591379450 |
| Fax |
|
| Email |
nishkabolar20@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nishka S Bolar |
| Address |
Post Graduate Student, Tejasvini Physiotherapy College, Kudupu, Mangalore |
| Type of Sponsor |
Other [Self Funded Study ] |
|
|
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 Subhashchandra Rai |
Tejasvini Physiotherapy College |
OPD Room, Tejasvini Physiotherapy College Opp Anantha Padmanbha Temple, Kudupu, Mangalore Dakshina Kannada KARNATAKA |
9448158751
physio.subhashrai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Maitland Mobilization Techniques |
To perform the mobilization, the patient lies prone with abdominal support for comfort. The therapist stands close, following assessment of each lumbar vertebra, the most painful segment is targeted with it being hyper mobile. Gentle, small amplitude, Posterior Anterior Pressure is applied centrally to the spinous process of each lumbar vertebra. This involves six sets of 30 second Oscillations, with the amplitude adjusted to the patients tolerance. Six repetitions will be performed on each of the three spinous processes once daily. The patients pain in reassessed before treating another vertebral segment. The entire PA mobilization session typically will last about 10 minutes. |
| Intervention |
Self Myofascal release |
The Self Myofascial Release procedure in this study involves as follows
A standard 6 X 36 inch foam roller and
Tennis ball.
The foam roller is selected as the primary tool for applying sustained pressure and Participants are instructed to use specific SMFR techniques on several key muscle group: the Quadratus Lumborum with three into 30 seconds hold, each followed by one minute rest; the Thoracolumbar fascia and Para vertebral muscles in the T12 to L1 region, three into 40 seconds applications, also separated by one minute rests; the Psoas muscle with three into 30 seconds hold and one minute intervals; and finally, the Piriformis and gluteal muscles, with three into 30 seconds holds, each followed by a minute rest period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with Nonspecific low back pain
Sub acute or Chronic
without referred leg pain
VAS greater than or equal to 4
studnets with age group between 18 to 30 years |
|
| ExclusionCriteria |
| Details |
Difficulty with isometric contractions or moderate physical exertion due to internal health issue (eg: Cardiovascular, pulmonary, systemic)
specific cause identified
known or suspected serious pathology
non mechanical low back pain
nerve root compromise
neurological signs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale |
Pre(Day 0) to Post(Day 6) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Schobers Method |
Pre(Day 0) to Post(Day 6) |
| Modified Oswestry Disability Index |
Pre(Day 0) to Post(Day 6) |
|
|
Target Sample Size
|
Total Sample Size="68" Sample Size from India="68"
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)
|
01/02/2026 |
| 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="1" Months="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nishkabolar20@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To Evaluate the effectiveness of Self Myofascial Release versus Maitland Mobilization Technique along with Mc Gill’s Big 3 Exercises among Non-Specific Low Back Pain. Low Back Pain, the most common cause of pain and disability worldwide, with approximately 90% cases affecting a substantial portion of the global population, this being classified as Non-Specific Low Back Pain (NSLBP). In 2025 the prevalence of low back pain is predictably going to reach up to 84% and the prevalence of chronic low back pain is 23%, the recurrent episode of pain and work disability in LBP is 44-78% and 26-37%. Commonly used therapeutic technique is Manual therapy which is used by therapist in treating Low Back pain, having techniques like Mobilization and Manipulations, Manual therapy can be done by using Myofascial Release and Mulligan Mobilization, Maitland Mobilization technique in management for NSLBP. Myofascial release (MFR) is a hands-on technique using pressure and stretching to ease tight tissues (fascia), reduce pain, and improve movement, which involves gentle, lasting pressure on sore spots, helping the fascia lengthen and relax. According to a systematic review, roller massage appears to be a method for increasing joint range of motion without a downside for muscle function. SMFR technique remarkably improves both pain and disability. Maitland mobilization, uses gentle, controlled movements of spinal joints within a patient’s pain-free limits, aiming to increase joint movement, decrease muscle tension, and relieve pain. Additionally, studies have investigated the effectiveness of Maitland mobilizations, in the management of NSLBP, highlighting the importance of a comprehensive assessment and treatment approach. Mc Gill’s Big 3 exercises are a widely utilized intervention in the management of NSLBP, targeting the trunk muscles to enhance spinal stability and pain which aim to activate and strengthen the muscles, improving their ability to stabilize the spine during movement and activities of daily living. It is important to note that optimal out comes are often achieved when core stability exercises are integrated into a comprehensive rehabilitation program that includes patient education, manual therapy, and other forms of exercise. Data will be collected from the students of Tejasvini Hospital Group of Institutions, Kudupu, Mangalore, Karnataka. Sample size was determined using the standard deviation of VAS, The estimated sample size is 34 in each group. Participants will be divide into two groups for the study , group A with SMFR along Mc Gill big 3 exercise and group B Maitland mobilization techniques along Mc Gill Big 3 exercise. This interventional study will be conducted in the Hospital setting to compare the effects of Self Myofascial Release versus Maitland Mobilization Technique with Mc Gill’s Big 3 exercise among Non-specific low back pain. Participants will be recruited through the selection criteria. Data collection will involve three components. To measure pain, Visual analog scale. To check ROM, Schober Method. Modified Oswestry Disability Index (MODI) questionnaire, evaluated the impact of LBP on the individual’s performance of daily activities. The Intervention will be conducted for one week with all the techniques and exercise given to patients.
|