| CTRI Number |
CTRI/2020/04/024951 [Registered on: 30/04/2020] Trial Registered Prospectively |
| Last Modified On: |
13/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga Therapy for management of 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 Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-11/2019-1404 Version 3 dated 05.03.2020 |
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 |
Spoorthi Poojari |
| Designation |
Student |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samasthana SVyasa |
| Address |
Eknath Bhavan, 19, Gavipuram Circle, Kempegowda Nagar, Banglore
Bangalore
KARNATAKA
560019
India |
| Phone |
9769215358 |
| Fax |
01722744401 |
| Email |
spoorthipoojari22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER 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 SVyasa |
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 |
Department of Anaesthesia, Pain Clinic, room number 5023, 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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated approach of Yoga therapy (IAYT) |
A series of 60 minutes Integrated approach of Yoga therapy (IAYT) class (for a span of 15 days), using all of the components of yoga at the body, subtle energy, and mind level, respectively will be conducted. It will be followed by yoga practise at home and follow ups at regular intervals. They will be asked to practice the techniques at home discussed in each session daily for up to 45 minutes, throughout the intervention period, and after classes end. |
| 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
|
|
|
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 |
| Functional Disability measured using Modified Oswestry Disability Index (MODI) |
At 3 monts |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain assessed using VNRS, DN4 and PCS, mental Health using HADS, Quality of Life using EuroQol and measure fear of movement i.e. Kinesiophobia using TAMPA Scale and patient global impression clinical improvement to measure of the overall clinical benefit from the treatment. Potential Pain Biomarkers using blood serum β – Endorphins, TNF – α and salivary assessment of CGRF will help us derive the effects of IAYT regime on pain and these biomarkers themselves |
Baseline. 15 days, one month and 3 months all except pain biomarkers which will be assessed at baseline 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published in pain practice |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized controlled trial has been planned to evaluate whether Integrated Approach of Yoga Therapy (IAYT), is more effective thanthe usual care. Patients from 18 to 65 years osage, with a history of low back pain for more than 3 months will be recruited A series of 60 minutes Integrated approach of Yoga therapy (IAYT) class (for a span of 15 days), using all of the components of yoga at the body, subtle energy, and mind level, respectively will be conducted. They will be asked to practice the techniques at home discussed in each session daily for up to 45 minutes, throughout the intervention period, and after classes end. 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 INDEX 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 |