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| Name | Class |
|---|---|
| Advanced Education & Research Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sphinx Pose Yoga Therapy | Experimental | 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. |
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| Mindfulness-Based Stress Reduction (MBSR) | Experimental | 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. |
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| Usual Care | Active Comparator | 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. |
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| Combined Yoga and MBSR | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sphinx Pose Yoga Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Measured using the Numerical Pain Rating (NPR) scale (0-10). | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |
| Functional Disability | Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%). | 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). | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) | Assessed using WHOQOL-BREF | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |
| Stress Levels | Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malir University of Science & Technology | Karachi | Sindh | 78500 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40510459 | Derived | Saleem Y, Noushad S, Ahmed S, Ansari B. Chronic low back pain management: clinical and psychophysiological outcomes of multimodal approaches-a randomised controlled trial on yoga and mindfulness. BMJ Open Sport Exerc Med. 2025 Jun 8;11(2):e002697. doi: 10.1136/bmjsem-2025-002697. eCollection 2025. |
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Participants will be randomly assigned to one of four intervention groups:
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| Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |
| Depression Symptoms | Evaluated via Beck Depression Inventory (BDI). | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |
| Anxiety Levels | Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale. | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |
| Heart Rate Variability (HRV) | Measured via wearable biofeedback device. | Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24). |