Comparative Study on Lumbar Spondylosis Management by Physiotherapy and Vatari Gugglulu: A Classical Anti-inflammatory Medicine
试验速览
- 阶段
- 2 期
- 状态
- Not Applicable
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain according to pain pressure threshhold (PPT) measured by pressure algometer, Pain measured in 5 positions (supine lying, more than 15 minutes standing, siting, walking and daily activities) by 100mm Visual Analogue Scale, Bone mineral density (BMD)
研究概览
简要总结
Lumbar Spondylosis is a global concern for increasing prevalence, longer duration, treatment cost, polypharmacy, absence in work, and disease burden. Lumbar spondylosis is the commonest form of degenerative low back pain and accounts for a wide range of interventions. Recent reports on global burden of disease indicates people living in the lower-middle income countries of Asia, specifically southeast Asia have the highest age-standard prevalence of low back pain, mostly degenerative low back pain. Conventional medicine addresses the painful impairments but fails to address the episodic disability, and also merely responsive to early degeneration. Physiotherapy, combined with manual therapy, exercise therapy, and lifestyle modification addresses the painful functional limitations, and prevention of early degeneration but lacks high quality evidence compared to medication. Classical medicines also have clinical outcome on the painful and degenerative issues, hence there are limited research in this field.
The proposed study will fill-up the research gap of high quality randomized clinical trial comparing physiotherapy, classical medicine and conventional medicine on painful functional limitations, fear avoidance belief on activities, and episodic disability for people having degenerative low back pain. The outcome will be evaluated through short term and long-term outcomes. The implication of this study will guide clinicians in evidence-based practice in a low-resource country and improve the healthcare services towards the people having degenerative low back pain. The study will also facilitate future research and funding in multi-center large-scale clinical trials. This study has hematology and toxicology evaluation, so the outcome will also be evaluated as safety of interventions, and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Low back pain for more than 3 months; and/or associated radiating pain at buttock or lower limbs in one or both sides, Radiological evidence of Vertebral body degeneration, osteophyte lipping, marginal osteophytes, reduced intervertebral space, calcified anterior longitudinal ligament of muscle spasm causing straitening of lumbar curvature evident by Digital X-ray of Lumbo-sacral spine Anterior-posterior and lateral view or narrowing or degeneration of facet join evident in X-ray of lumbar spine oblique view, Pain level at 100-milimeter visual analogue scale between 20 and 70 (Mild to moderate), Osteoporesis diagnosed by Bone mineral density test, Conesent for participating the trial voluntarily.
排除标准
- •Neurological sign of duramater or nerve root compression due to disc herniation, Hematology and toxicology tests indicating unsitable for trial interventions, Any history of surgery of any part of spine, Drop-out within the first week of recruitment.
结局指标
主要结局
Pain according to pain pressure threshhold (PPT) measured by pressure algometer, Pain measured in 5 positions (supine lying, more than 15 minutes standing, siting, walking and daily activities) by 100mm Visual Analogue Scale, Bone mineral density (BMD)
时间窗: 90 days
次要结局
- Fear avoidance belief that limits people to be involved in functional activities due to pain by Fear avoidance belief questionnaire scale, Disability due to LBP by Oswestry disability index scale, Serum vitamin D3 level, Serum B12 level
研究者
Mohammad Shahadat Hossain
Jahangirnagar University