| CTRI Number |
CTRI/2025/09/094967 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| 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
|
Comparison of Spine and Leg Alignment Therapy with Ear Acupressure versus Core Exercises for Pain and Function in People with Sub-acute Low Back Pain” Auricular Therapy versus Core muscle strengthening exercises on Pain and function in Sub Acute Low Back Pain. |
|
Scientific Title of Study
|
A Comparative study of Comprehensive Spine and Lower Limb Alignment therapy with Auricular Therapy versus Core muscle strengthening exercises on Pain and function in Sub Acute Low Back Pain. |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jayeshkumar VinodrayThakrar |
| Designation |
PhD scholar |
| Affiliation |
Associate Professor, Nootan college Of Physiotherapy,SPU |
| Address |
PhD pursuing Room no.B007 Second Floor
Department Of Physiotherapy
Jagannath University
Jaipur Rajasthan
Nootan College Of Physiotherapy Visnagar Gujarat
Mahesana
GUJARAT
384315
India |
| Phone |
9898233164 |
| Fax |
|
| Email |
jayeshthakrar2107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAditi Singh |
| Designation |
Professor |
| Affiliation |
Department Of Physiotherapy Jagannath University, Jaipur, Rajasthan |
| Address |
Room no.B007 Second Floor
Department Of Physiotherapy
Jagannath University
Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7737402909 |
| Fax |
|
| Email |
aditi.singh@jagnnathuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
DrAditi Singh |
| Designation |
Professor |
| Affiliation |
Department Of Physiotherapy Jagannath University, Jaipur, Rajasthan |
| Address |
Room no.B007 Second Floor
Department Of Physiotherapy
Jagannath University
Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7737402909 |
| Fax |
|
| Email |
aditi.singh@jagnnathuniversity.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jagannath University,Jaipur |
| Address |
Room No B007 Second Floor Department Of Physiotherapy JagnnathUniversity Jaipur |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jayeshkumar Vinodray Thakrar |
Nootan College Of Physiotherapy |
Room no 2
Nootan College Of Physiotherapy
Sankalchand Patel University
Visnagar 384315
Mahesana
GUJARAT |
9898233164
jayeshthakrar2107@gmail.com |
| Jayeshkumar Vinodray Thakrar |
Rachna Clinic & Research Center |
Shop no.44 Sona complex ITI Chokadi visnagar gujarat 384315
Mahesana
GUJARAT |
9898233164
jayeshthakrar2107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Jagannath University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Spine and Lower Limb Alignment therapy with Auricular Therapy |
Among population, subjects with low back pain will be selected and assessed, consent will be taken for the further study in written. Subjects were selected as per the inclusion and exclusion criteria, then the Pre-intervention data will be collected, treatment protocol will be explained and demonstrated with its benefits Moist Heat 5 min, comprehensive spine and Lower Limb Alignment therapy 5 min with Auricular Therapy 1 min. After 2 week again outcome measure assess. and then data analysis and statistical analysis will be done. |
| Comparator Agent |
core muscles strengthening |
Pelvic Tilt in Crook Lying, Pelvic Tilt in 4 Point Kneel,4 Point Kneel with Combined Arm and Leg Lift, Bridge, Bent Leg Side Lifts, Horizontal Hold, Straight Leg Side Lifts this 7 exercise use for subacute law back pain pre and post treatment assessment collect and then Data analysis and statistical analysis will be done. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 30 to 50 yrs
2. Both genders
3. Acute low back pain NPRS greater then 5
4. ODI Score less then 80 percentage
5. Disc Prolapse Up to III Grade
|
|
| ExclusionCriteria |
| Details |
1. Congenital or any Spine deformities
2. Pregnancy
3. During Menstrual Period
4. Neurological Involvement /deficits
5. Spondylolisthesis
6. Spine surgeries
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain through NPRS |
Pain through NPRS 0 week 3 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index |
Oswestry Disability Index 0 week 3 week |
| Pressure biofeedback |
o week and 3 week |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
28/09/2025 |
| 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="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
- Who will be able to view these files?
Response - Anyone
- 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 [jayeshthakrar2107@gmail.com].
- For how long will this data be available start date provided 08-11-2025 and end date provided 08-11-2027?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Initially population will decided to conduct the study, Among population, subjects with low back pain will be selected and assessed consent will be taken for the further study in written Subjects were selected as per the inclusion and exclusion criteria then the Pre-intervention data will be collected treatment protocol will be explained and demonstrated data will be collected from subjects and then Data analysis will be done The Data will be collected and then further used for Statistical Analysis |