Chronic Low Back Pain Management: Clinical and Psychophysiological Outcomes of Multimodal Approaches - A Randomized Controlled Trial on Yoga and Mindfulness.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Fear Avoidance Beliefs Questionnaire (FABQ) work subscale score must be < 19.
排除标准
- •Subjects with high risk for physical injuries during exercise.
- •Pregnant and/or lactating females.
- •Subjects with musculoskeletal disorders.
研究组 & 干预措施
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.
干预措施: Sphinx Pose Yoga Therapy (Behavioral)
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.
干预措施: Sphinx Pose Yoga Therapy (Behavioral)
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.
干预措施: Sphinx Pose Yoga Therapy (Behavioral)
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.
干预措施: Sphinx Pose Yoga Therapy (Behavioral)
结局指标
主要结局
Pain Intensity
时间窗: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Measured using the Numerical Pain Rating (NPR) scale (0-10).
Functional Disability
时间窗: Baseline (Week 0), Post-Intervention (Week 12), Follow-up (Week 24).
Assessed via the Oswestry Low Back Pain Disability Questionnaire (0-100%).
Physiological Markers
时间窗: 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).
次要结局
- 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).)
研究者
Shamoon Noushad
Lecturer
University of Karachi