| CTRI Number |
CTRI/2025/09/094409 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| 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
|
comparing two exercise methods for reducing back pain
building muscle strength and improving everyday activities. |
|
Scientific Title of Study
|
EFFECTIVENESS OF MOTOR CONTROL EXERCISES VERSUS SENSORY MOTOR EXERCISES ON PAIN, CORE MUSCLE ENDURANCE AND DISABILITY AMONG INDIVIDUALS WITH NONSPECIFIC LOW BACK PAIN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HETAVI VIPUL HARIYA |
| Designation |
PG Student |
| Affiliation |
PARUL INSTITUTE OF PHYSIOTHERAPY |
| Address |
B,101 KAAMVAN APARTMENT
VASANT KARISHMA COMPLEX
AMBADI ROAD
VASAI WEST B,101 KAAMVAN APARTMENT
VASANT KARISHMA COMPLEX
AMBADI ROAD
VASAI WEST
MAHARASHTRA 401202 India |
| Phone |
9765977728 |
| Fax |
|
| Email |
hetavihariya2714@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr BHAVANA GADHAVI |
| Designation |
Dean at faculty of physiotherapy |
| Affiliation |
PARUL INSTITUTE OF PHYSIOTHERAPY |
| Address |
PARUL INSTITUTE OF PHYSIOTHERAPY PARUL UNIVERSITY P.O LIMDA TAL.WAGHODIA DIST.VADODARA GUJARAT. PARUL INSTITUTE OF PHYSIOTHERAPY PARUL UNIVERSITY P.O LIMDA TAL.WAGHODIA DIST.VADODARA GUJARAT. Vadodara GUJARAT 391760 India |
| Phone |
9727729787 |
| Fax |
|
| Email |
bhavana.gadhavi28222@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr HETAVI VIPUL HARIYA |
| Designation |
Student |
| Affiliation |
PARUL INSTITUTE OF PHYSIOTHERAPY |
| Address |
B,101 KAAMVAN APARTMENT
VASANT KARISHMA COMPLEX
AMBADI ROAD
VASAI WEST
B,101 KAAMVAN APARTMENT
VASANT KARISHMA COMPLEX
AMBADI ROAD
VASAI WEST
MAHARASHTRA 401202 India |
| Phone |
9765977728 |
| Fax |
|
| Email |
hetavihariya2714@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL SEVASHRAM HOSPITAL,PARUL UNIVERSITY,LIMDA,VADODARA,391760,INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 HETAVI VIPUL HARIYA |
PARUL SEVASHRAM HOSPITAL |
ORTHO OPD,ROOM NO 18,GROUND FLOOR
VADODARA. Vadodara GUJARAT |
9765977728
hetavihariya2714@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Motor control exercises
|
For Motor control exercises
flexion control exercises
SQUAT AND STAND WITH SPINE IN NEUTRAL.
KNEE EXTENSION IN SITTING.
QUADRUPED POSITION AND ROCK PELVIS BACKWARD.20REPS
extension control exercises
POSTERIOR PELVIC TILT IN PRONR
PRONE SLR WITH PILLOW
rotational control exercises
CROOK LYING LIMB INTO ABDUCTION WITHOUT ANY ROTATION OF PELVIS.
|
| Comparator Agent |
SENSORY MOTOR EXERCISES |
BALANCE TRAINING
DEAD BUG EXERCISE
BIRD DOG
SINGLR LEG STANCE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with non- specific low back pain since not less than 6 weeks.
Pain on visual analogue scale not more than 7. |
|
| ExclusionCriteria |
| Details |
Recent history of falls within 6 months
Musculoskeletal issues such as any degenerative ,any infective and specific condition of lumbar spine
Any thoracic and abdominal surgery within 6 months
Any injury or operative condition. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VISUAL ANALOGUE SCALE |
BASE LINE AND POST 4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| modified Oswestry disability index & pressure biofeedback |
BASELINE AND POST 4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
25/09/2025 |
| 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="9" 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hetavihariya2714@gmail.com].
- For how long will this data be available start date provided 15-12-2025 and end date provided 23-09-2031?
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
|
Non-specific low back pain is a common musculoskeletal condition leading to pain, functional limitations, and decreased core stability. Effective rehabilitation strategies are essential to reduce pain, improve muscle endurance, and enhance functional ability. Sensory Motor Exercises focus on proprioceptive training and balance to restore sensorimotor control, whereas Motor Control Exercises emphasize re-education of deep trunk muscles for spinal stability. This study aims to compare the effectiveness of Sensory motor exercises and Motor control exercises on pain reduction, core muscle endurance, and disability levels in patients with. The primary outcomes include pain intensity Core endurance pressure biofeedback and functional disability Modified Oswestry Disability index. The study seeks to provide evidence on which intervention yields better clinical outcomes for management. |