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

March 28, 2025 updated by: Shamoon Noushad, University of Karachi

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 78500
        • Malir University of Science & Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.
Active Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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).
Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Assessed using WHOQOL-BREF
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).
Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale.
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).
Evaluated via Beck Depression Inventory (BDI).
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).
Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale.
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).
Measured via wearable biofeedback device.
Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Karachi

Collaborators

Advanced Education & Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBP-YM-RCT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Low-back Pain (cLBP)

Clinical Trials on Sphinx Pose Yoga Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe