Yoga and Mindfulness for Chronic Low Back Pain: A Randomized Controlled Trial

Not Applicable

• Conditions: Chronic Low-back Pain (cLBP)

• Registration Number: NCT06910982
• Lead Sponsor: University of Karachi

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study Start: 2025-04-01
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-12-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Life (QoL)	Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).	Assessed using WHOQOL-BREF
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).
Anxiety Levels	Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).	Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale.
Heart Rate Variability (HRV)	Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).	Measured via wearable biofeedback device.

Trial Locations

Locations (1)

Malir University of Science & Technology; 🇵🇰 Karachi, Sindh, Pakistan