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

NCT06910982 | Enrolling By Invitation

• 1 other identifier: CLBP-YM-RCT-2025
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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)

Keywords

Chronic Low Back Pain; Yoga Therapy; Mindfulness-Based Stress Reduction; Sphinx Pose; Functional Disability

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (5)

• Quality of Life (QoL)

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

• Stress Levels

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

• Depression Symptoms

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

• Anxiety Levels

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

• Heart Rate Variability (HRV)

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

Study Arms (4)

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.

Behavioral: Sphinx Pose Yoga Therapy

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.

Behavioral: Sphinx Pose Yoga Therapy

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.

Behavioral: Sphinx Pose Yoga Therapy

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.

Behavioral: Sphinx Pose Yoga Therapy

Interventions

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.

Combined Yoga and MBSR; Mindfulness-Based Stress Reduction (MBSR); Sphinx Pose Yoga Therapy; Usual Care

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with high risk for physical injuries during exercise.
• Pregnant and/or lactating females.
• Subjects with musculoskeletal disorders.

Sponsors & Collaborators

• University of Karachi: lead
• Advanced Education & Research Center: collaborator

Study Sites (1)

Malir University of Science & Technology

Karachi, Sindh, 78500, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 40510459 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned to one of four intervention groups: * Group A (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, with sessions occurring thrice weekly. * Group B (MBSR): Participants will engage in Mindfulness-Based Stress Reduction (MBSR) sessions, combining mindfulness meditation and stretching to cultivate awareness and reduce stress. Sessions will include mindfulness meditation practices, body scan exercises, gentle yoga movements, and discussions on stress reduction and coping strategies, occurring weekly. * Group C (Usual Care): Participants will receive usual care as per The Back Book. * Group D (Combined Yoga and MBSR): Participants will receive a combined intervention of Sphinx Pose Yoga therapy and MBSR, incorporating elements from both programs, occurring twice weekly.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PA (1)