The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders − 0.08 [90% CI (− 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.

该研究的目的是证明有症状的膝骨关节炎（KOA）的低频水疗联合康复治疗（Spa-rehab）与标准水疗在6个月时的非劣效性。进行了一项前瞻性，随机，单中心，非劣效性试验，招募了社区症状性KOA患者。标准水疗包括标准水疗治疗，每周3天，每周6天，水疗修复包括水疗疗程，每周3天，每周3天，然后进行专门的康复计划，每周3天，共3周。主要终点指标是在6个月时达到视觉类似评分上的疼痛的最小临床重要改善（MCII）和/或WOMAC指数上的功能的MCII，并且没有进行膝关节手术（复合MCII）。次要终点是3个月时的复合MCII，在3个月和6个月时达到疼痛和功能的患者可接受症状状态（PASS）。在283例患者中，有145例被分配到标准水疗治疗，而138例被分配到Spa康复治疗。我们无法证明Spa康复疗法在主要终点指标上的非劣效性：应答者的差异为-0.08 [90％CI（-0.18至0.02），p  ＝ 0.14]。但是，两组之间的差异检验并不显着（p  = 0.18）。对于复合MCII在3个月时或在3个月和6个月时通过PASS，Spa康复疗法不逊于标准spa疗法。有症状的KOA患者可以合理地建议进行Spa康复治疗。该协议可能比标准的水疗疗法更具成本效益，并且避免住在中心附近的患者因工作和住宿而缺勤。