Yoga Therapy for management of chronic low back pain

Phase 4

Completed

Conditions: Other specified acquired deformities of musculoskeletal system,

Registration Number: CTRI/2020/04/024951

Lead Sponsor: PGIMER Chandigarh

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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
Functional Disability measured using Modified Oswestry Disability Index (MODI)	At 3 monts

Secondary Outcome Measures

Name	Time	Method
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 Î² â€“ Endorphins, TNF â€“ Î± 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

Trial Locations

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