To Evaluate efficacy of Integrated Yoga Therapy versus Physiotherapy for Chronic Low Back Pain in elderly adults- A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of Integrated Yoga Therapy versus Physiotherapy in reducing intensity of pain in elderly patients with Chronic Low Back Pain using the 11-point Numerical Rating Scale (NRS).
Study Overview
Brief Summary
The study is aimed at evaluating the efficacy of Integrated Yoga Therapy vs Physiotherapy as management option for chronic low back pain in elderly patients. Patients will be provided with 2 weeks of monitored therapy followed by 10 weeks of home based follow up. Patients will be evaluated for pain using the 11 point Numerical Rating Scale at baseline, 1 month, 2 month and 3 month. They will also be assessed for feasibility , improvement in spinal flexibility, improvement id back disability, body mass composition and serum IGF-1 levels at baseline, 1 month and 3rd month. The patients in both the groups will be advised to continue their pharmacological therapy they are receiving which will be reviewed and modified during follow up according to the need of the patients.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 60.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with chronic low back pain for more than three months of moderate intensity 2.Age between 60-80 years 3.ASA grade 1-3 patients.
Exclusion Criteria
- •1.Patients practicing yoga more than 4 times per month 2.Patients undergoing physiotherapy for back pain in previous 3 months 3.Chronic low back pain due to uncommon causes such as congenital, infective, inflammatory, traumatic, neoplasm and metabolic conditions 4.Referred low back pain due to gynaecological diseases, genitourinary problems, or gastrointestinal conditions.
Outcomes
Primary Outcomes
To evaluate the efficacy of Integrated Yoga Therapy versus Physiotherapy in reducing intensity of pain in elderly patients with Chronic Low Back Pain using the 11-point Numerical Rating Scale (NRS).
Time Frame: 1 month. 2 month, 3 months
Secondary Outcomes
- To compare Integrated Yoga Therapy with Physiotherapy for(1)Feasibility and safety of therapy in elderly population)
- 2)Improvement in spinal flexibility by goniometer
- 3)Improvement in disability due to LBP by Oswestry Disability Index (ODI)(1 month, 3 month)
- 4)Anabolic effect of therapy by improvement in serum IGF-1 level(1 month, 3 month)
- 5)Effect on body mass composition(1 month, 3 month)