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Enrolling by invitationNCT06910982Updated Apr 4, 2025

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

An interventional study of Sphinx Pose Yoga Therapy in Chronic Low-back Pain (cLBP), sponsored by University of Karachi. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by University of Karachi · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Low-back Pain (cLBP)

Keywords

  • Chronic Low Back Pain
  • Yoga Therapy
  • Mindfulness-Based Stress Reduction
  • Sphinx Pose
  • Functional Disability
03

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subjects with high risk for physical injuries during exercise.
  • Pregnant and/or lactating females.
  • Subjects with musculoskeletal disorders.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • BehavioralSphinx 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.

05

What researchers measure

Primary outcomes

  1. Pain Intensity

    Measured using the Numerical Pain Rating (NPR) scale (0-10).

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

  2. Functional Disability

    Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).

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

  3. 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).

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

Secondary outcomes

  1. Quality of Life (QoL)

    Assessed using WHOQOL-BREF

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

  2. Stress Levels

    Measured by Sadaf Stress Scale (SSS) - Physical Stress Subscale.

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

  3. Depression Symptoms

    Evaluated via Beck Depression Inventory (BDI).

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

  4. Anxiety Levels

    Assessed using Generalized Anxiety Disorder 7 (GAD-7) scale.

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

  5. Heart Rate Variability (HRV)

    Measured via wearable biofeedback device.

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

06

Study locations

1 site
  • Malir University of Science & Technology
    Karachi, Sindh 78500, Pakistan
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06910982
Lead sponsor
University of Karachi
Collaborators
Advanced Education & Research Center
Responsible party
Shamoon Noushad (Lecturer, University of Karachi) — Principal investigator
First posted
Apr 4, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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