| CTRI Number |
CTRI/2020/05/025396 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
13/11/2023 |
| 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
|
Yoga Therapy versus usual care for chronic Low Back pain |
|
Scientific Title of Study
|
Effectiveness of Integrated Approach of Yoga Therapy (IAYT) versus usual care in management on Chronic Low Back Pain Patients: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-11/2019-1392 V3 dated 5.03.2020 |
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
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
160012
India |
| Phone |
7087009533 |
| Fax |
01722744401 |
| Email |
ghaibabita1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
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 |
| Swami Vivekananda Yoga Anusandhana Samasthana |
Eknath Bhavan, 19, Gavipuram Circle, Kempegowda Nagar, Banglore-560019 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Babita Ghai |
PGIMER Chandigarh |
Pain Clinic, 5th Floor, New OPD Block, PGIMER, Sector-12
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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated approach of Yoga therapy (IAYT) |
A series of 90 minutes Integrated approach of Yoga therapy (IAYT) class (table 1) (for a span of 15 days, 6 days/week), using all of the components of yoga at the body, subtle energy, and mind level, respectively will be conducted. After 15 days regular class, the partcipants will be attending 2 hourly once wekly recuritment sesion for next 2 weeks. Therafter once a month 2 hourly session will be held for next 6 months. |
| Comparator Agent |
Usual Care |
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. Patients will be adhering to the treatment protocol for the same duration, under the guidance of pain care physician and physiotherapist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults indicative of low back pain with or without leg pain for more than 3 months, Average pain intensity of ≥ 4 on a Numeric Rating scale (NRS), Participants who are willing to participate, Who are ready to travel and attend yoga classes, and are willing to continue home practise
|
|
| ExclusionCriteria |
| Details |
- Pain due to organic causes such as infective and inflammatory conditions, or degenerative disorders of the muscles.
- Critically ill and is unable to participate due to severe pain.
- Patients diagnosed with fixed lumbar spinal canal stenosis or sacroiliac joint dysfunction.
- Severe Obesity
- Chronic pain occurred 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.
- Patients with pre-existing psychiatric illness.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Integrated Approach of Yoga Therapy (IAYT), in comparison with the usual care regime as a management for functional disability (using MODQ) and pain (using VNRS) in CLBP patients. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effect of IAYT on pain biomarkers
To assess the effects of IAYT on Mental Health (using HADS), and Quality of Life (using EuroQol), pain catastrophizing (using PCS) and measure Kinesiophobia (using TAMPA Scale) related to chronic CLBP. |
Biomarkers at baseline, 12, 26 and 52 weeks
other secondary outcomes at baseline, 4, 8, 12, 26, and 52 weeks |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
30/06/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomised controlled trial has been planned to evaluate whether Integrated Approach of Yoga Therapy (IAYT), is more effective thanthe usual care. Also the mechanistic role of IAYT therapy will be assessed by studying pain biomarkers. Patients from 18 to 65 years osage, with a history of low back pain for more than 3 months will be recruited Patient control trial will be undertaken to examine the effect of Integrated Approach of Yoga Therapy (IAYT) on patients of Chronic Low back pain (CLBP) (N = 122). About 61 patients will be subjected to IAYT and 61 patients will be subjected to conventional treatment after obtaining the ethical clearance. The follow up will be done at 6-time points (4, 8, 12, 26, and 52 weeks) and score estimation for salivary markers will also be carried out. The results will shed light that how IAYT is able to relieve the patients as an adjunct to conventional treatment. Various methods will be used for participants adherence and encouragement such as WhatsApp group for encouragements at regular intervals. Also WhatsApp photo/video updates, Yoga pamphlet on the guidelines of practise, A video CD will also be etc. They will be following a similar practise routine for next span of intervention. ASSESSMENT TOOLS ASSESSMENT FOR PAIN MEASURES: Numeric rating scale (NRS) ASSESSMENT FOR DISABILITY INDE: Modified Oswestry Disability Index (MODI) PAIN ASSESSMENT: Douleur Neuropathie 4 (DN4), Pain Catastrophizing Scale (PCS) ASSESSMENT FOR HEALTH RELATED QUALITY OF LIFE: EuroQol (EQ-5D- 5L)
ASSESSMENT FOR MENTAL HEALTH: Hospital Anxiety and Depression Scale (HADS) ASSESSMENT FOR FEAR OF MOVEMENT: The Tampa Scale of Kinesiophobia (TSK) ASSESSMENT FOR CLINICAL BENEFIT FROM THE TREATMENT: Patient Global Impression of Change scale (PGIC) Medication assessment ASSESSMENT USING PAIN BIOMARKERS: B endorphins, TNFalpha, CGRP, VGEF
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