Yoga Therapy versus usual care for chronic Low Back pain

Phase 4

Recruiting

Conditions: Acquired deformity of musculoskeletal system, unspecified,

Registration Number: CTRI/2020/05/025396

Lead Sponsor: Post Graduate Institute of Medical Education and Research Chandigarh

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 122

Inclusion Criteria

Adults indicative of low back pain with or without leg pain for more than 3 months, Average pain intensity of â‰¥ 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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): PGIMER Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Babita Ghai
Principal investigator
7087009533
ghaibabita1@gmail.com