| CTRI Number |
CTRI/2025/07/090195 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| 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
|
Effect of Lumbopelvic Stabilization exercises and Conventional Physiotherapy on hand grip strength, pain and function in Adult having Low Back Pain-A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Lumbopelvic Stabilization Exercises and Conventional Physiotherapy on Hand Grip Strength Pain and Function in Adults Having 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 |
Surabhi Sakharam Khune |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College Datta Meghe Higher Education and Research Sawangi Wardha
Acharaya Vinoba Bhave Rural Hospital Datta Meghe Higher Education and Research Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
09172391336 |
| Fax |
|
| Email |
surabhikhune@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumik Basu |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College Datta Meghe Higher Education and Research Sawangi Wardha
Acharaya Vinoba Bhave Rural Hospital Datta Meghe Higher Education and Research Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9762165015 |
| Fax |
|
| Email |
physiosoumik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surabhi Sakharam Khune |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College Datta Meghe Higher Education and Research Sawangi Wardha
Acharay Vinoba Bhave Rural Hospital Datta Meghe Higher Education and Research Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
09172391336 |
| Fax |
|
| Email |
surabhikhune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Datta meghe Institute of Higher Education and Research Wardha Maharashtra India 442001 |
| 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 |
| Dr Surabhi Sakharam Khune |
Aacharya Vinoba Bhave Rural Hospital datta meghe higher education and research center sawangi wardha |
MSK IPD male ward 35, and female ward 37
Wardha
MAHARASHTRA |
09172391336
surabhikhune@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy |
This highlights the need for targeted research that specifically examines how these therapies can enhance adults daily activities and overall physical development. |
| Intervention |
Lumbopelvic stabilization exercises |
All exercise are done 4 times per week for 3 weeks for 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Effect of lumbopelvic stabilization exercises in adults having low back pain |
|
| ExclusionCriteria |
| Details |
1.Traumatic low back pain
2.Adults with neurological disorders affecting motor function.
3.Adults with severe scoliosis or other significant spinal deformities.
4.Any acute injuries, fractures, or surgeries in the lower back or upper extremities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
|
baseline 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quebec back pain disability scale |
baseline 3 weeks |
Quebec back pain disability scale
Handgrip strength |
baseline 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/07/2025 |
| 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="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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [surabhikhune@gmail.com].
- For how long will this data be available start date provided 01-09-2025 and end date provided 01-10-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Problem of the study In adults, low back pain develops as they grow, with its incidence and prevalence influenced by several factors, including age, sex, body composition, and physical activity levels. Approximately 20% to 30% of adults may exhibit some degree of abnormal curvature, which can be exacerbated by factors such as sedentary lifestyle, poor postural habits, and insufficient core strength.
Solution The scope includes providing insights into targeted rehabilitation strategies that address both postural alignment and functional strength and also, by identifying the most effective approach, helping to improve the physical health and quality of life of adults.
|