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

NCT ID: NCT06910982

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-06-30

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.

Conditions

Chronic Low-back Pain (cLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Sphinx Pose Yoga Therapy

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.

Group Type: EXPERIMENTAL

Sphinx Pose Yoga Therapy

Intervention Type: 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.

Mindfulness-Based Stress Reduction (MBSR)

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.

Group Type: EXPERIMENTAL

Sphinx Pose Yoga Therapy

Intervention Type: 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.

Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Sphinx Pose Yoga Therapy

Intervention Type: 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.

Combined Yoga and MBSR

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.

Group Type: EXPERIMENTAL

Sphinx Pose Yoga Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Education & Research Center

OTHER

Sponsor Role: collaborator

University of Karachi

OTHER

Sponsor Role: lead

Responsible Party

Shamoon Noushad

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Malir University of Science & Technology

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 40510459 (View on PubMed)

Other Identifiers

CLBP-YM-RCT-2025

Identifier Type: -

Identifier Source: org_study_id