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Enrolling by invitation NCT06910982

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

No phase Interventional Chronic Low-back Pain (cLBP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sphinx Pose Yoga Therapy.
Who it may be relevant to
Registry conditions: Chronic Low-back Pain (cLBP). Basic parameters: 25 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Pain Intensity [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
  • Functional Disability [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
  • Physiological Markers [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
Secondary outcome measures (5)
  • Quality of Life (QoL) [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
  • Stress Levels [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
  • Depression Symptoms [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
  • Anxiety Levels [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]
  • Heart Rate Variability (HRV) [Time frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Pakistan · 1 center
  • Malir University of Science & Technology — Karachi

Publications

  • 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

Identifiers

NCT: NCT06910982 · CLBP-YM-RCT-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗