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NCT Number: NCT06910982

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

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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Key information

Conditions

Chronic Low-back Pain (cLBP)

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malir University of Science & Technology

Karachi, Sindh, 78500, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Measured using the Numerical Pain Rating (NPR) scale (0-10).

  2. Functional Disability

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).

  3. Physiological Markers

    Time frame: 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 outcomes

  1. Quality of Life (QoL)

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Assessed using WHOQOL-BREF

  2. Stress Levels

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale.

  3. Depression Symptoms

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Evaluated via Beck Depression Inventory (BDI).

  4. Anxiety Levels

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale.

  5. Heart Rate Variability (HRV)

    Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

    Measured via wearable biofeedback device.

Sponsors and collaborators

Lead sponsor

University of Karachi

Other

Collaborators

  • Advanced Education & Research Center

Registry information

Official study title

Chronic Low Back Pain Management: Clinical and Psychophysiological Outcomes of Multimodal Approaches - A Randomized Controlled Trial on Yoga and Mindfulness.

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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