Long Term Follow-up of Comprehensive Physiotherapy Following Disc Herniation Operation: Results of a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Low back pain rating scale (LBP-RS)
研究概览
简要总结
Hitherto no comprehensive long-term follow-up data of 10 years and more have been obtained from survivors of disc surgery that would have considered the type of postoperative care.
Objectives: 1) To evaluate the long-term effects of postoperative comprehensive physiotherapy starting 1 week after lumbar disc surgery. 2) To assess the relative risk of segmental instability in the operated segment 12 years following lumbar disc surgery.
详细描述
Design: Twelve years' follow-up of a three-armed, randomized, controlled, single blinded clinical trial. Setting: Outpatient department of Physical Medicine & Rehabilitation. Participants: Of 120 patients following first-time, uncomplicated lumbar disc surgery who participated in the original study are invited to a 12 years follow-up examination. Interventions: In the original study, patients had been randomly assigned to "comprehensive physiotherapy", "sham intervention" (neck massage), or no therapy. Measurements: Low Back Pain Rating Score (LBPRS; Manniche 1993), functional X-rays of the lumbar spine. All data are collected by blinded students and physicians at the Department of PM&R, Vienna Medical University.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had completed the treatment originally allocated
- •all patients who had undergone a first time uncomplicated disc surgery for lumbar vertebral disc herniation who had taken part in the original RCT and had not completed the treatment originally allocated
排除标准
- 未提供
结局指标
主要结局
Low back pain rating scale (LBP-RS)
时间窗: 12 years after Randomization
The LBP-RS measures the health concepts of pain, disability, and physical impairment. Both the original and the translated version of the LBP rating scale are highly reliable within and between raters, uni-dimensional and are shown to have satisfactory construct validity. The sum score ranges from 130 (worst) to 0 (best) and is the composite of 3 subscores (pain, disability, and physical function).
次要结局
- Satisfaction with treatment(12 years)
- Use of health care resources(12 years)
- Psychological questionnaires(12 years)
研究者
Prof. Dr. Gerold Ebenbichler
Prof Dr Gerold Ebenbichler
Medical University of Vienna