An interventional study of Sphinx Pose Yoga Therapy in Chronic Low-back Pain (cLBP), sponsored by University of Karachi. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by University of Karachi · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
participants will undergo Sphinx Pose Yoga therapy involving gentle stretching exercises aimed at extending the back and activating muscles along the spine. Sessions will be conducted three times per week for 12 weeks.
Behavioral: Sphinx Pose Yoga Therapy
Participants will engage in weekly MBSR sessions, which include mindfulness meditation, body scan exercises, gentle yoga movements, and stress reduction discussions. The intervention will last 12 weeks.
Behavioral: Sphinx Pose Yoga Therapy
Participants will receive usual care as per "The Back Book," which includes standard guidelines for managing chronic low back pain (CLBP) without additional yoga or mindfulness interventions.
Behavioral: Sphinx Pose Yoga Therapy
Participants will receive a combined intervention consisting of Sphinx Pose Yoga therapy and MBSR, integrating elements from both programs. Sessions will be held twice per week for 12 weeks.
Behavioral: Sphinx 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.
Pain Intensity
Measured using the Numerical Pain Rating (NPR) scale (0-10).
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Functional Disability
Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Physiological Markers
Cortisol (stress response). β-Endorphins (BE) (pain modulation). Substance-P (SP) (pain neurotransmitter). Interleukin-6 (IL-6) and C-reactive protein (CRP) (inflammation).
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Quality of Life (QoL)
Assessed using WHOQOL-BREF
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Stress Levels
Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale.
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Depression Symptoms
Evaluated via Beck Depression Inventory (BDI).
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Anxiety Levels
Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale.
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Heart Rate Variability (HRV)
Measured via wearable biofeedback device.
Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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University of Karachi