Comparison of the Clinical Effect on Common Low Back Pain of a Thermal Cure With Dry Rehabilitation: A Randomized Therapeutic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- VAS pain
研究概览
简要总结
Objective: To compare the benefits, with regard to low back pain (LBP) symptoms, of a thermal cure and a dry rehabilitation treatment.
Methods: Randomized therapeutic trial including patients with LBP, randomly divided into two groups. Thermal cure consisted of underwater shower, massage-jet showers, hydro-massage, pool rehabilitation and peloid therapy. Dry rehabilitation consisted of analgesic physiotherapy, muscle strengthening and group physical rehabilitation. The primary endpoint was based on the Visual Analog Scale (VAS) of pain at day 18 (Day 18). The other outcome measures were the Oswestry Disability Index (ODI), the Short Form-36 (SF36) questionnaire and spine mobility. Follow-up was carried out for 12 months.
详细描述
Low back pain (LBP) is a very common pathology affecting more than 80% of the population. The pain and the limitation of movements cause significant functional discomfort, resulting in some form of disability and an added handicap. It therefore constitutes a major public health problem due to its impact on the quality of life and its high socio-economic cost.
The medical care for LBP aims to reduce pain and thus improve the functional capacities of patients. Among non-drug adjuvant treatments, the role of thermal cure is far from clear. Indeed, even if the use of thermo-mineral waters for therapeutic purposes is a very old and widespread practice in rheumatology, the study of the efficiency of thermal cures in the treatment of LBP, in particular compared to dry rehabilitation, has been the subject of only a limited number of medical publications. In Tunisia, the Tunisian Hydrotherapy Office estimates that at the end of 2017 the number of spa guests reached 51,324 for all the thermal resorts. However, there are no studies evaluating the effectiveness of such treatments.
We report the results of a randomized therapeutic trial, carried out with the aim of comparing the clinical effects of thermal cures and dry rehabilitation on common LBP.
Patient selection The selection of patients to be referred to the thermal center was made among patients treated in the rheumatology department of the Mongi Slim Hospital; a university hospital center located in La Marsa and not related to the thermal center. The inclusion visit allowed the investigating doctors to collect demographic data and clinical history, in order to verify the inclusion criteria and to have the informed consent signed in French or in Arabic depending on patients' choice.
Randomization The choice of the type of treatment to be delivered was determined by means of randomization provided by the senior investigator in accordance with the Zelen method. Neither the doctors participating in the study nor the patients were informed beforehand of the type of treatment that will be delivered, thermal cure (group 1) or dry rehabilitation (group 2). Each group of patients was unaware of the existence of the other group and its type of treatment.
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 (Participant, Investigator)
盲法说明
Neither the doctors participating in the study nor the patients were informed beforehand of the type of treatment that will be delivered, thermal cure (group 1) or dry rehabilitation (group 2).
Each group of patients was unaware of the existence of the other group and its type of treatment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low back pain (LBP) evolving for more than 12 weeks.
- •Visual analog scale (VAS) of pain greater than 30.
排除标准
- •Patients with a loss of autonomy or with impaired intellectual abilities
- •Patients with contraindications to a thermal cure (infectious or progressive inflammatory pathologies, unbalanced blood hypertension, decompensated heart disease, respiratory failure, decompensated neurological or psychiatric illness, age greater than 75 years, pregnancy, purulent skin lesions).
- •Patients having undergone an epidural infiltration (within 3 months) or spinal surgery (within 1 year)
- •Patients who received physical rehabilitation or balneotherapy during the year preceding inclusion, and finally patients using stage 3 analgesics (World Health Organization classification).
研究组 & 干预措施
Thermal cure
The thermal treatment used hot, chlorinated and sodium water. Every day, the patients received 4 out of the 5 following treatments: underwater showers (15 minutes), shower-massage (10 minutes), hydromassage (20 minutes), swimming pool rehabilitation (20 minutes) and application of heated peloid (15 minutes).
Patients were accommodated in the care center for 18 days. Treatments were delivered in the morning on a daily basis, except on Sundays.
干预措施: thermal cure (Other)
dry rehabilitation
The thermal treatment used hot, chlorinated and sodium water. Every day, the patients received 4 out of the 5 following treatments: underwater showers (15 minutes), shower-massage (10 minutes), hydromassage (20 minutes), swimming pool rehabilitation (20 minutes) and application of heated peloid (15 minutes).
干预措施: dry rehabilitation (Other)
结局指标
主要结局
VAS pain
时间窗: Day 18
Pain was assessed using a visual analog scale (VAS) with a vertically held ruler graduated from 0 to 10. The VAS score for low back pain was then expressed in millimeters, ranging from 0 mm (no pain) to 100 mm (maximum pain). The primary endpoint was VAS pain, blindly assessed by the same doctor for each patient on the last day of the treatment (Day 18).
次要结局
- VAS pain(at 3 months, 6 months and 12 months after the end of the treatment)
- the OSWESTRY Disability Index (ODI)(at Day 18, month 3, month 6 and month 12.)
- the quality of life score SF-36(at Day 18, month 3, month 6 and month 12)
- spinal mobility(at Day 18, month 3, month 6 and month 12)
研究者
Fazaa Alia
Associate professor
Tunis University