| CTRI Number |
CTRI/2023/04/052075 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Integrated Yoga Therapy versus Physiotherapy for Chronic Low Back Pain in elderly adults. |
|
Scientific Title of Study
|
To Evaluate efficacy of Integrated Yoga Therapy versus Physiotherapy for Chronic Low Back Pain in elderly adults- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ishita Sood |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, sector 12, Chandigarh |
| Address |
Department of Anaesthesiology and Intensive Care, 4th floor, A block, Nehru hospital, PGIMER, sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988701153 |
| Fax |
|
| Email |
ishitasood08@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Bharti |
| Designation |
Professor |
| Affiliation |
PGIMER, sector 12, Chandigarh |
| Address |
Department of Anaesthesiology and Intensive Care, 4th floor, A block, Nehru hospital, PGIMER, sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neerja Bharti |
| Designation |
Professor |
| Affiliation |
PGIMER, sector 12, Chandigarh |
| Address |
Department of Anaesthesiology and Intensive Care, 4th floor, A block, Nehru hospital, PGIMER, sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Collaborative Centre for Mind Body Interventions through Yoga(CCMBIY) Scheme established by Central Council for Research in Yoga and Naturopathy (CCRYN), PGIMER, sector 12 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Central Council og Research and Naturopathy |
| Address |
61-65, Institutional area, Janakpuri, New Delhi- 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Ishita Sood |
Post Graduate Institute of Medical Education and Research |
Collaborative Centre for Mind Body Medicine, PGIMER, Chandigarh
Department of Physiotherapy, Level 1, New OPD, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9988701153
ishitasood08@yahoo.in |
|
|
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: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Yoga Therapy Module |
Monitored Yoga therapy focused on low back pain will be provided to patients for the first 2 weeks followed by 10 weeks of self practice |
| Comparator Agent |
Physiotherapy |
Monitored Physiotherapy focusing on the low back pain will be provided to the patients for the first 2 weeks followed by 10 weeks of home based practice |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with chronic low back pain for more than three months of moderate intensity
2. Age between 60-80 years
3. ASA grade 1-3 patients
|
|
| ExclusionCriteria |
| Details |
1. Patients practicing yoga more than 4 times per month
2. Patients undergoing physiotherapy for back pain in previous 3 months
3. Chronic low back pain due to uncommon causes such as congenital, infective, inflammatory, traumatic, neoplasm and metabolic conditions
4. Referred low back pain due to gynaecological diseases, genitourinary problems, or gastrointestinal conditions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Integrated Yoga Therapy versus Physiotherapy in reducing intensity of pain in elderly patients with Chronic Low Back Pain using the 11-point Numerical Rating Scale (NRS). |
1 month. 2 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare Integrated Yoga Therapy with Physiotherapy for
1) Feasibility and safety of therapy in elderly population |
1 month, 3 months |
2) Improvement in spinal flexibility by goniometer
|
1 month, 3 month |
| 3) Improvement in disability due to LBP by Oswestry Disability Index (ODI) |
1 month, 3 month |
| 4) Anabolic effect of therapy by improvement in serum IGF-1 level |
1 month, 3 month |
| 5) Effect on body mass composition |
1 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/05/2023 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is aimed at evaluating the efficacy of Integrated Yoga Therapy vs Physiotherapy as management option for chronic low back pain in elderly patients. Patients will be provided with 2 weeks of monitored therapy followed by 10 weeks of home based follow up. Patients will be evaluated for pain using the 11 point Numerical Rating Scale at baseline, 1 month, 2 month and 3 month. They will also be assessed for feasibility , improvement in spinal flexibility, improvement id back disability, body mass composition and serum IGF-1 levels at baseline, 1 month and 3rd month. The patients in both the groups will be advised to continue their pharmacological therapy they are receiving which will be reviewed and modified during follow up according to the need of the patients. |