Comparison of Integrated Approach of Yoga Therapy (IAYT) versus Usual Care in Management of Chronic Low Back Pain Using Quantitative Sensory Testing
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Central Council For Research In Yoga And Naturopathy
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- To evaluate changes in the Verbal Numeric Rating Scale (NRS) and Quantitative Sensory Testing (QST) parameters Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in patients with CLBP
Overview
Brief Summary
This prospective, Randomized ,parallel group clinical trial will compare the effectiveness of the Intergrated Approach of Yoga Therapy (IAYT) versus usual care in patients with chronic non- specific low back pain. A total of 82 adult participants with low back pain for more than three months and a pain score of (NRS) more than 5 will be randomized in a 1:1 ratio to either receive IAYT or usual care. The IAYT group will undergo 60 minute yoga sessions over 2 weeks including physical, postures, breathing exercises, and meditation, followed by Home practice. The usual care group will receive standard advice on ergonomics, posture, physical activity, and a back care booklet. Participants will be assessed at baseline, four weeks and at 12 weeks for pain intensity (NRS) , disability (modified oswestry, disability index), quality of life (EQ – 5D), and quantitative sensory testing parameters (pressure, pain threshold, and conditioned pain modulation). The primary aim is to estimate the difference in pain, intensity, and sensory testing parameters between groups and to demonstrate the effectiveness of yoga as an adjunct in managing chronic low back pain. The study will be conducted at the pain clinic, department of anaesthesia and intensive care, PGIMER, Chandigarh from January 2025 to June 2026.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •History of non-specific low back pain (LBP) with symptoms persisting for more than three months Failure to respond to conservative management Numerical Rating Scale (NRS) score of greater than or equal to 5 at the time of enrolment Age grater than 18 years Ambulatory and naïve to yoga.
Exclusion Criteria
- •LBP caused by nerve root compression, disc prolapse, spinal stenosis, tumor, spinal infection, ankylosing spondylitis, spondylolisthesis, kyphosis, structural scoliosis, or widespread neurological disorders Pre-surgical candidates Compromised cardiopulmonary system Pregnancy Body mass index (BMI) greater than 35 Individuals experiencing major depression or substance abuse Participants who are unable to communicate in either Hindi or English.
Outcomes
Primary Outcomes
To evaluate changes in the Verbal Numeric Rating Scale (NRS) and Quantitative Sensory Testing (QST) parameters Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in patients with CLBP
Time Frame: at baseline, 4 weeks, 12 weeks
Secondary Outcomes
- 1) To study the changes in the results of the Modified Oswestry Low Back Pain Disability Index (MODI) & EuroQOL (EQ-5D) in patients with CLBP at baseline(at baseline, 4 weeks, 12 weeks)
Investigators
NIKHIL MANUKONDA
tion Post Graduate Institute of Medical Research