Integrated Approach of Yoga Therapy (IAYT) for Chronic low back pain
- Conditions
- Other biomechanical lesions,
- Registration Number
- CTRI/2024/01/062077
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research Chandigarh
- Brief Summary
Chronic low back pain (CLBP), is a common public health problem affecting millions of people and a leading cause of disability than any other condition worldwide. The complex nature of the CLBP demands shifting away from the **biomedical model**to a multidimensional bio-psycho-social **model**for management. Yoga and Mindfulness-based stress reduction (MBSR), have shown potential positive effects in CLBP patients management. This study will evaluate the effectiveness of Yoga on pain symptoms and pain-associated disability in adult patients with Chronic Low Back Pain (CLBP) and compare it with physical exercise or usual care. We also plan to evaluate the mechanistic role, using pain biomarker at molecular level and using quantitative sensory testing at neural level (by studying any changes with peripheral and central sensitization), following IAYT compared to physical exercise or usual care
Eligible and willing participants will be randomized to one of three groups that is group 1: IAYT group 2: physical therapy group 3: usual care. The patients will be assessed for socio-demographic and clinical information. This will be followed by other clinically approved questionnaires such as DN4, PCS, MODQ, Euro Qol-5D-5L, HADS and Tampa Scale for Kinesiophobia. They will also be assessed for biomarkers (β – Endorphins, TNF – α, IL-6, IL-8, S cortisol, S ACTH, BDNF, CGRF, VEGF) as well as quantitative sensory testing (QST) at baseline, 1 month, 3 months and 6 months, and the results shall be compared.
This study will provide both the clinical and molecular outcomes and mechanistic role of IAYT, which will be useful for clinical translation and integration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 264
Patients, with a history of non-specific low back pain with or without leg pain for more than 3 months, with average pain intensity of ≥ 4 on a Numeric Rating scale (NRS), who are willing to participate, who are ready to attend Yoga classes or physical exercise, and are willing to continue home practise will be recruited.
Patients with chronic pain occurring 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, pregnant females and patients with pre-existing major psychiatric illness will also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in dysfunction as measured by MODQ and Pain as measured by VNRS 6 months
- Secondary Outcome Measures
Name Time Method improvement in MODQ as ≥ 50% and effective pain relief as ≥ 50% reduction from baseline on VNRS. Proportion of patients achieving clinically meaningful improvement on MODQ and effective pain relief (EPR) in each group will considered as primary endpoint. 1, 3, AND 6 months
Trial Locations
- Locations (1)
PGIMER Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
PGIMER Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Babita GhaiPrincipal investigator7087009533ghaibabita1@gmail.com