Primary Osteoarthritis Lumbar Spine Presenting as Chronic Low Back Pain or Sciatica or Both (Prolapsed Lumbar Disc Syndrome): Establishing Its Cause, Pathogenesis and Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 6
- 主要终点
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
The study was about a root cause of Primary Osteoarthritis Lumbar Spine producing disabilities in sitting, climbing and walking etc. In advance stage the person is bereft of his/her personal physical activities. The prevalent treatment is temporary and dis-satisfactory. A new treatment was designed and a trial was conducted on 154 patients (100 in the trial group, 50 in the control group) for a duration of six months.
详细描述
The study was focused on establishing the cause, pathogenesis and treatment of painful Lumbar Spine disease (Primary Osteoarthritis Lumbar Spine = OA Lumbar Spine) at present the exact cause and treatment are not known. It was aimed to find out to latter through a hypothesis by designing a treatment and testing it with a clinical trial.
This established that the deficient full extension of the spinal joints (intervertebral joints between the adjacent vertebrae from T12 to S1) producing contracture in their capsules in front, was the cause and the correction (Contracture Correction Therapy = CCT) was the cure of the disease. The correction was carried out by intermittent and sustained extension of the lumbar spin through three designed body postures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age =>30 and <=90 years
- •Back/leg pain or both combined, which appears without any apparent cause, exacerbated by exertion and subsides by rest.
- •Presence of limited morning stiffness
- •No history of infection, inflammation or trauma to rule out secondary OA
- •Disability in sitting, climbing stairs or walking
排除标准
- •Frozen shoulder
- •Central obesity
- •Acute Lumbago
- •X-ray spine with no OA signs
结局指标
主要结局
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: Change from baseline The Western Ontario and McMaster Universities Arthritis Index Osteoarthritis score at 6, 12, 24 weeks
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
次要结局
- Oswestry Disability Index(Change from baseline Oswestry Disability Index score at 6, 12, 24 weeks)
- EuroQol Visual Analogue Scale score(Change from baseline EuroQol Visual Analogue Scale score at 6, 12, 24 weeks)
研究者
DR R C Agrawal
Principal Investigator
Knee Pain Clinic