Clinical trial NCT06910982: Yoga and Mindfulness for Chronic Low Back Pain: A Randomized Controlled Trial
Official title: Chronic Low Back Pain Management: Clinical and Psychophysiological Outcomes of Multimodal Approaches - A Randomized Controlled Trial on Yoga and Mindfulness.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Chronic Low Back Pain
Yoga Therapy
Mindfulness-Based Stress Reduction
Sphinx Pose
Functional Disability
Lead sponsor: University of Karachi
Sponsor class: OTHER
Collaborators: name: Advanced Education & Research Center
First posted: 2025-04-04
Enrollment: 220
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
measure: Functional Disability
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
measure: Physiological Markers
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
measure: Stress Levels
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
measure: Depression Symptoms
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
measure: Anxiety Levels
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
measure: Heart Rate Variability (HRV)
timeFrame: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Malir University of Science & Technology
state: Sindh
Study officials:
References: