| CTRI Number |
CTRI/2024/01/062077 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Integrated Approach of Yoga Therapy (IAYT) for Chronic low back pain |
|
Scientific Title of Study
|
Evaluating the long term effect of Integrated Approach of Yoga Therapy (IAYT) on physical and mental health, quality of life and biomarkers in patients with chronic low back pain and comparing it with physical exercise or usual care: A community based randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-06/2022-2450 v3 dated 22.09.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Babita Ghai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Babita Ghai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Babita Ghai |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology of Yoga and Meditation (SATYAM), Government of India, Ministry of Science and Technology, Technology Bhawan, New Mehrauli Road, New Delhi-110016 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Sector-12
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Science and Technology Satyam |
Govt of India,
Ministry of Science and Technology, Department of Science and Technology, Technology Bhawan, New Mehrauli Road, New Delhi, 110016 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Babita Ghai |
PGIMER Chandigarh |
Pain Clinic, 5th Floor, New OPD Block, PGIMER, Sector-12
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
7087009533
01722744401
ghaibabita1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PHYSICAL EXERCISE GROUP |
Physical exercise will be provided by two trained expert in managing CLBP patients. The exercise intervention group will be similar to yoga group in terms of length, number of classes and amount of physical exertion required.
Initial supervised classes First 15 days: 90 minutes supervised class, 6 days/week,
Recruitment classes: 2 hourly once weekly recruitment session for 3rd and 4th weeks. Thereafter once a month 2 hourly session will be held for next 6 months
At home: Participants will be advised to follow the yoga practise at home of atleast of 45 minutes daily with atleast 5 days/week throughout the study period |
| Comparator Agent |
Usual care group |
Control Group will be given Conventional Standard Care Regime involving Medication, Stretching exercises self-care book with information on causes of back pain and advice on exercising, appropriate lifestyle modifications. The participants will be provided with a “Back care booklet†designed by the principal investigator and professional group of this trial. This booklet provides information on causes of back pain and advice on exercising, appropriate lifestyle modifications. They will be adhering to the treatment protocol for the same duration, under the guidance of pain care physician and physiotherapist. |
| Intervention |
YOGA GROUP |
Yoga Therapy (IAYT) protocol has been designed for Chronic Low back pain patients by the expert fraternity will be provided by trained personal as follows
Initial supervised classes First 15 days: 90 minutes supervised class, 6 days/week,
Recruitment classes: 2 hourly once weekly recruitment session for 3rd and 4th weeks. Thereafter once a month 2 hourly session will be held for next 6 months.
At home: Participants will be advised to follow the yoga practise at home of atleast of 45 minutes daily with atleast 5 days/week throughout the study period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients, with a history of non-specific low back pain with or without leg pain for more than 3 months, with average pain intensity of ≥ 4 on a Numeric Rating scale (NRS), who are willing to participate, who are ready to attend Yoga classes or physical exercise, and are willing to continue home practise will be recruited. |
|
| ExclusionCriteria |
| Details |
Patients with chronic pain occurring due to cancer or involvement of fibromyalgia, diabetic neuropathy and other systematic complications such as cardiac, kidney disorders, patients who have undergone lower back region surgery, pregnant females and patients with pre-existing major psychiatric illness will also be excluded. Patients with chronic pain occurring due to cancer or involvement of fibromyalgia, diabetic neuropathy and other systematic complications such as cardiac, kidney disorders, patients who have undergone lower back region surgery, pregnant females and patients with pre-existing major psychiatric illness will also be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dysfunction as measured by MODQ and Pain as measured by VNRS |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in MODQ as ≥ 50% and effective pain relief as ≥ 50% reduction from baseline on VNRS. Proportion of patients achieving clinically meaningful improvement on MODQ and effective pain relief (EPR) in each group will considered as primary endpoint. |
1, 3, AND 6 months |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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 4 |
|
Date of First Enrollment (India)
|
01/12/2026 |
| 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="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ghaibabita1@gmail.com].
- For how long will this data be available start date provided 01-02-2024 and end date provided 01-02-2029?
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
|
Chronic low back pain (CLBP), is a common public health problem affecting millions of people and a leading cause of disability than any other condition worldwide. The complex nature of the CLBP demands shifting away from the biomedical model to a multidimensional bio-psycho-social model for management. Yoga and Mindfulness-based stress reduction (MBSR), have shown potential positive effects in CLBP patients management. This study will evaluate the effectiveness of Yoga on pain symptoms and pain-associated disability in adult patients with Chronic Low Back Pain (CLBP) and compare it with physical exercise or usual care. We also plan to evaluate the mechanistic role, using pain biomarker at molecular level and using quantitative sensory testing at neural level (by studying any changes with peripheral and central sensitization), following IAYT compared to physical exercise or usual care Eligible and willing participants will be randomized to one of three groups that is group 1: IAYT group 2: physical therapy group 3: usual care. The patients will be assessed for socio-demographic and clinical information. This will be followed by other clinically approved questionnaires such as DN4, PCS, MODQ, Euro Qol-5D-5L, HADS and Tampa Scale for Kinesiophobia. They will also be assessed for biomarkers (β – Endorphins, TNF – α, IL-6, IL-8, S cortisol, S ACTH, BDNF, CGRF, VEGF) as well as quantitative sensory testing (QST) at baseline, 1 month, 3 months and 6 months, and the results shall be compared. This study will provide both the clinical and molecular outcomes and mechanistic role of IAYT, which will be useful for clinical translation and integration. |