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

University of Karachi

Status: Invitation-only

Conditions: Chronic Low-back Pain (cLBP)

Treatments: Behavioral: Sphinx Pose Yoga Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06910982

CLBP-YM-RCT-2025

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 4 patient groups

Sphinx Pose Yoga Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Sphinx Pose Yoga Therapy

Mindfulness-Based Stress Reduction (MBSR)

Experimental group

Description:

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.

Treatment:

Behavioral: Sphinx Pose Yoga Therapy

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Sphinx Pose Yoga Therapy

Combined Yoga and MBSR

Experimental group

Description:

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.

Treatment:

Behavioral: Sphinx Pose Yoga Therapy