Phase 4 Study of Glucosamine Sulphate in the Treatment for Chronic Low Back Pain Patients With Degenerative Lumbar MRI Findings
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.
Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Low back pain for more than 6 months
- •Patient older than 25 years old
- •MRI findings comparable with lumbar degenerative/osteoarthritic changes.
排除标准
- •Spinal stenosis with neurological deficits
- •Spinal prolapse with neurological deficits
- •Rheumatoid arthritis, psoriatic arthritis,
- •Old lumbar fractures
- •Chronic pain syndromes (e.g. fibromyalgia)
- •Psychosocial status not suitable for participation
- •Pregnancy
- •Breastfeeding
- •Allergic to shellfish
研究组 & 干预措施
Glucosamine Sulphate
干预措施: Glucosamine sulphate (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 1 year
The primary outcome was scores on the Norwegian version of Roland Morris Disability Questionnaire (RMDQ). RMDQ is a widely used back-specific, self-administered measure of pain-related disability. Greater levels of disability give higher numbers on a 24-point scale. RMDQ has content and construct validity and internal consistency. It is also reproducible and sensitive to change over time for LBP patients. A 3-point reduction in the total RMDQ was a priori classified as a response to treatment.
次要结局
- Visual Analogue Scale(1 year)
- EuroQol-5D(1 year)