Chronic Low-back Pain (cLBP)
Conditions
Keywords
Chronic Low Back Pain, Yoga Therapy, Mindfulness-Based Stress Reduction, Sphinx Pose, Functional Disability
Brief summary
Chronic low back pain (CLBP) is a leading cause of disability, significantly impacting quality of life and work productivity. Traditional treatments often provide limited relief, necessitating alternative approaches. This multicenter, parallel-arm, randomized controlled trial (RCT) aims to evaluate the efficacy of Sphinx Pose Yoga Therapy (Yoga), Mindfulness-Based Stress Reduction (MBSR), and their combination in managing CLBP among healthcare providers (HCPs). Participants will be randomly assigned to one of four groups: Group A (Yoga Therapy): Sphinx Pose Yoga therapy, practiced three times per week. Group B (MBSR): Weekly mindfulness meditation, body scan, and gentle stretching. Group C (Usual Care): Standard treatment guidelines as per The Back Book. Group D (Combined Yoga & MBSR): Integrated approach, practiced twice per week. The study will assess pain intensity, functional disability, quality of life, physiological markers, mental health, and heart rate variability. Outcomes will be measured at baseline (Week 0), post-intervention (Week 12), and follow-up (Week 24). The trial aims to determine whether Yoga, MBSR, or their combination provides superior benefits over usual care in CLBP management.
Interventions
BEHAVIORALSphinx Pose Yoga Therapy
A structured yoga-based intervention focusing on the Sphinx Pose, aimed at improving spinal flexibility and reducing pain. Participants will perform three sessions per week for 12 weeks.
Sponsors
Advanced Education & Research Center
University of Karachi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to one of four intervention groups: * Group A (Sphinx Pose Yoga therapy): Participants will undergo Sphinx Pose Yoga therapy, involving gentle stretching exercises aimed at extending the back and activating muscles along the spine, with sessions occurring thrice weekly. * Group B (MBSR): Participants will engage in Mindfulness-Based Stress Reduction (MBSR) sessions, combining mindfulness meditation and stretching to cultivate awareness and reduce stress. Sessions will include mindfulness meditation practices, body scan exercises, gentle yoga movements, and discussions on stress reduction and coping strategies, occurring weekly. * Group C (Usual Care): Participants will receive usual care as per The Back Book. * Group D (Combined Yoga and MBSR): Participants will receive a combined intervention of Sphinx Pose Yoga therapy and MBSR, incorporating elements from both programs, occurring twice weekly.
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Both genders between 25 to 45 years of age. * Subjects having low back pain complaints and have visited the healthcare provider in recent days. * Numerical Pain Rating (NPR) scale score ≥ 2 for their pain intensity. * Roland Morris Disability Questionnaire subject's score should be ≥ 4. * Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score must be \< 19.
Exclusion criteria
* Subjects with high risk for physical injuries during exercise. * Pregnant and/or lactating females. * Subjects with musculoskeletal disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Measured using the Numerical Pain Rating (NPR) scale (0-10). |
| Functional Disability | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%). |
| Physiological Markers | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Cortisol (stress response). β-Endorphins (BE) (pain modulation). Substance-P (SP) (pain neurotransmitter). Interleukin-6 (IL-6) and C-reactive protein (CRP) (inflammation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Levels | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale. |
| Quality of Life (QoL) | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Assessed using WHOQOL-BREF |
| Heart Rate Variability (HRV) | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Measured via wearable biofeedback device. |
| Stress Levels | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale. |
| Depression Symptoms | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). | Evaluated via Beck Depression Inventory (BDI). |
Countries
Pakistan
Outcome results
None listed