| CTRI Number |
CTRI/2025/08/092292 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Creating and Testing a Yoga Therapy Program for Long-Term Low Back Pain |
|
Scientific Title of Study
|
Designing, Validation, Feasibility and Reliability of an Integrated Yoga Therapy Module for Chronic Lower Backache |
| 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 Rakesh Kumar Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Science |
| Address |
Department of Sangyaharan, Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415624830 |
| Fax |
|
| Email |
rkj41a@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
NEHA |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute of Medical Science |
| Address |
Department of Sangyaharan, Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07309601587 |
| Fax |
|
| Email |
N669599@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
NEHA |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute of Medical Science |
| Address |
Department of Sangyaharan, Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
07309601587 |
| Fax |
|
| Email |
N669599@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department Of Sangyaharan |
| Address |
Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi 221005 |
| Type of Sponsor |
Government medical 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 |
| NEHA |
Sir Sunder Lal Hospital |
OPD No. 15& 16A, SS Hospital Banaras Hindu University Varanasi 221005
Varanasi
UTTAR PRADESH |
07309601587
N669599@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 |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group using Ayurvedic
Medicine or other alternative therapies with or without medication |
45 days |
| Intervention |
Yogic practices for Lower back pain |
45 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 60 years
Diagnosed with chronic lower back pain (lasting more than 12 weeks)
Pain intensity: mild to moderate (e.g., VAS score 3–7)
Able to participate in yoga therapy sessions
Medically stable, no acute illness
Willing to provide informed consent
No recent spinal surgery (within past 6 months) |
|
| ExclusionCriteria |
| Details |
Acute lower back injury or recent trauma
Spinal surgery in the last 6 months
Diagnosed with severe spinal disorders (e.g., tumor, fracture, infection)
Neurological deficits (e.g., foot drop, loss of bladder control)
Severe osteoporosis or arthritis limiting mobility
Uncontrolled chronic diseases (e.g., diabetes, hypertension, cardiac issues)
Pregnant women
Individuals with mental health conditions affecting participation
Currently undergoing other physical therapy or alternative treatments for back pain
Not willing to follow study protocols or attend regular sessions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain intensity
Improvement in functional disability |
45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improved quality of life (e.g., using WOMAC Scale)
Reduced stress and anxiety (e.g., via Hamilton Depression Rating Scale)
Improved spinal flexibility and posture
Better sleep quality
Adherence and satisfaction with yoga therapy module |
45days |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
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 study focuses on the development and scientific validation of an integrated yoga therapy module tailored for individuals suffering from chronic lower backache. The module is designed by combining classical yogic practices with therapeutic relevance. The research evaluates its feasibility in real-world settings, reliability across participants, and its effectiveness in reducing pain and disability. The goal is to provide a safe, structured, and holistic intervention that can be easily implemented for long-term back pain relief. |