Non-pharmacological Treatment for Chronic Back Pain: a Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 358
- 试验地点
- 2
- 主要终点
- Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain
研究概览
简要总结
The working hypothesis is that spa therapy in addition to usual care including home exercises (UCHE) will result in greater improvements in pain reduction, associated disability and quality of life for chronic low back pain patients. It follows that health resource consumption and linked costs should also be reduced. The primary objective of this study is therefore to compare the therapeutic effect of UCHE alone versus spa therapy in addition to UCHE for chronic low back pain.
详细描述
Secondarily, the study will also (i) evaluate the therapeutic effects specific to each spa-centre, (ii) specifically describe effects among subjects who are currently engaged in a professional activity, (iii) evaluate treatment tolerance as well as (iv) per-patient health resource use and associated costs.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient presenting with chronic low back pain: usual pain of the lumbar region lasting for more than 3 months. This pain may radiate to the buttocks, iliac crest, and does not go past the knee.
- •Patient presenting with a current pain intensity on a visual analogue scale (VAS) > or = 40 mm.
- •The patient has signed the informed consent
- •The patient is a beneficiary of a social security programme [national health insurance]
排除标准
- •Patients with secondary low back pain
- •Patients with severe depression, psychosis
- •Patients who have already had a spa treatment in the previous 6 months
- •Patients with a contraindication for spa treatment
- •Patients with a professional activity related to hydrotherapy (to avoid any conflict of interest)
- •Patients with sciatic pain beyond the knee (sciatica being a non-indication for spa treatment)
- •Other treatments that may interact according to the judgment of the investigator
- •Patients who live more than 30 km away from the spa
结局指标
主要结局
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain
时间窗: 6 months
Presence/absence of a clinically relevant change in visual analogue scale (VAS) score for pain, defined by an improvement of at least 30%; cases where patients demonstrate a 30% improvement in VAS scores for pain but nevertheless require hospitalisation for back pain during the study follow-up period will be considered as treatment failures (absence of clinically relevant change).
次要结局
- Huskinsson's VAS for pain.(12 months)
- The Fear Avoidance and Belief Questionnaire (FABQ)(12 months)
- Patient Acceptable Symptom State (PASS)(12 months)
- Overall opinion of the patient on his/her state of health (5-point Likert scale)(12 months)
- Daily drug consumption over the past 72 hours: Analgesics(12 months)
- The EIFEL scale(12 months)
- Daily drug consumption over the past 72 hours: Corticosteroids(12 months)
- Daily drug consumption over the past 72 hours: Benzodiazepine muscle relaxants:(12 months)
- Estimated per-patient cost for one year of care(12 months)
- Overall opinion of the evaluating physician on the patient's state of health (5-point Likert scale)(12 months)
- The EQ-5D-5L questionnaire(12 months)
- Daily drug consumption over the past 72 hours: NSAIDs(12 months)
- Number of infiltrations(12 months)