Centre de Recherche Rhumatologique et Thermal, 15 avenue Charles de Gaulle, 73100, Aix-les-Bains, France.
Departments of Medical Information and Respiratory Diseases, Univ Montpellier, CHU Montpellier, Montpellier, France.
Trials. 2020 May 11;21(1):392. doi: 10.1186/s13063-020-04271-9.
Low back pain is highly prevalent and a major source of disability worldwide. Spa therapy is frequently used to treat low back pain, but the associated level of evidence for efficacy is insufficient. To fill this knowledge gap, this protocol proposes an appropriately powered, prospective, evaluator-blinded, multi-centre, two-parallel-arm, randomised (1:1), controlled trial that will compare spa therapy in addition to usual care including home exercise (UCHE) versus UCHE alone for the treatment of chronic low back pain.
Eligible patients (anticipated sample size of 358) will have had low back pain for more than 3 months and scores for pain greater than 40 mm on a visual analogue scale (VAS). Following initial consent for UCHE and baseline evaluations, patients are randomised (1:1) to UCHE alone, or UCHE plus spa therapy (18 days of mud packs, underwater massages, showers and water exercises under medical supervision). Patients in the latter arm will be requested to sign an additional consent form as per Zelen randomisation. Follow-up visits will occur at approximately months 1, 6 and 12 and (along with baseline assessments) will cover changes over time in VAS pain scores, the impact of lower back pain on daily life (the Rolland and Morris Disability Questionnaire (RMDQ)), inappropriate fears and beliefs about lower back pain (the fear, avoidance, belief questionnaire (FABQ)), general quality of life (the Euroqol Group 5 dimension, 5 level questionnaire (EQ-5D-5 L)), Patient Acceptable Symptom State (PASS), consumption of analgesic drugs and nonsteroidal anti-inflammatory drugs (NSAIDs), and overall state of health. Health resource use and days of sick leave (and subsequently the associated costs) will also be recorded. The primary outcome is the presence/absence of a clinically relevant change (improvement of at least 30%) in the VAS score for pain at 6 months.
Despite the fact that previous, rather dated recommendations encourage spa therapy for the treatment of low back pain, the current literary corpus is methodologically poor. This protocol has been designed to provide results spanning a thorough range of outcomes at the highest evidence level possible.
ClinicalTrials.gov: NCT03910023. Registered on 10 April 2019.
腰痛在全球范围内普遍存在，是导致残疾的主要原因之一。水疗经常被用于治疗腰痛，但相关疗效的证据水平不足。为了填补这一知识空白，本方案提出了一项经过充分论证的、前瞻性的、评估者盲法的、多中心、平行双臂、随机（1:1）、对照试验，该试验将比较水疗联合常规治疗（包括家庭运动治疗）与单纯常规治疗（家庭运动治疗）对慢性腰痛的治疗效果。
符合条件的患者（预计纳入 358 例）腰痛时间超过 3 个月，视觉模拟评分（VAS）疼痛评分大于 40mm。在初始同意接受家庭运动治疗和基线评估后，患者以 1:1 的比例随机分为家庭运动治疗组或家庭运动治疗加水疗组（18 天泥敷、水下按摩、淋浴和水疗，在医学监督下进行）。水疗组的患者将被要求根据 Zelen 随机化签署额外的同意书。随访将在大约 1、6 和 12 个月时进行，（与基线评估一起）将涵盖 VAS 疼痛评分随时间的变化、腰痛对日常生活的影响（罗尔兰德和莫里斯残疾问卷（RMDQ））、对腰痛的不合理恐惧和信念（恐惧、回避、信念问卷（FABQ））、一般生活质量（欧洲五维健康量表，五水平问卷（EQ-5D-5L））、患者可接受的症状状态（PASS）、镇痛药和非甾体抗炎药（NSAIDs）的消耗以及整体健康状况。还将记录卫生资源的使用和病假天数（以及随后的相关费用）。主要结局是在 6 个月时 VAS 疼痛评分的临床相关变化（至少改善 30%）的存在/缺失。
尽管之前的、相当陈旧的建议鼓励水疗治疗腰痛，但目前的文献资料在方法学上存在不足。本方案旨在提供尽可能高的证据水平的全面的结果。
ClinicalTrials.gov：NCT03910023。于 2019 年 4 月 10 日注册。
