Dainese Paolo, Stautemas Jan, De Mits Sophie, Wittoek Ruth, Van Ginckel Ans, Huysse Wouter, Demeyer Heleen, Mahieu Hanne, Calders Patrick
Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Ghent, Belgium.
Department of Rheumatology, Ghent University Hospital, Ghent, Belgium.
Rheumatol Adv Pract. 2024 Oct 30;8(4):rkae133. doi: 10.1093/rap/rkae133. eCollection 2024.
This randomized controlled trial (RCT) investigated whether adding daily use of flat flexible footwear (FFF) to a strengthening and aerobic exercise program improved short- and longer-term outcomes compared with adding stable supportive shoes (SSS) in people with medial tibiofemoral OA.
Participants ( = 97) with medial tibiofemoral OA were randomly assigned (1:1) to the FFF ( = 50) or SSS ( = 47) group. Participants in both groups received a 9-month intervention (3 months supervised followed by 6 months unsupervised exercise). The primary outcome was the change in knee pain on walking at 3 months measured using an 11-point numeric rating scale (NRS). Secondary outcomes included the change from baseline to 3 and 9 months in the severity of knee pain overall (NRS), physical function (WOMAC subscale), habitual physical activity level (Physical Activity Scale for the Elderly), quality of life (QoL) (European Quality of Life 5-Dimensions 5-Levels questionnaire) and markers of inflammation (effusion and Hoffa synovitis) and structural disease progression (bone marrow lesions).
There were no significant differences between the groups in the change in pain on walking [between-group difference -0.67 (95% CI -1.62, 0.29)] at 3 months. Knee pain on walking and overall knee pain significantly decreased in both groups at 3 and 9 months. Physical function and QoL improved in both groups at 3 and 9 months. We found no between-group differences in any secondary outcome at any time.
FFF added to exercise therapy did not provide additional better symptom nor structure-modification benefit compared with conventional SSS and exercise in people with medial tibiofemoral OA.
ClinicalTrials.gov (http://clinicaltrials.gov), NCT03796832.
本随机对照试验（RCT）研究了在胫股内侧骨关节炎患者中，在强化和有氧运动计划中每日添加扁平柔性鞋（FFF）与添加稳定支撑鞋（SSS）相比，是否能改善短期和长期疗效。
97名胫股内侧骨关节炎患者被随机（1:1）分配至FFF组（n = 50）或SSS组（n = 47）。两组参与者均接受为期9个月的干预（3个月有监督，随后6个月无监督运动）。主要结局是使用11点数字评定量表（NRS）测量的3个月时行走时膝关节疼痛的变化。次要结局包括从基线到3个月和9个月时膝关节总体疼痛严重程度（NRS）、身体功能（WOMAC子量表）、习惯性身体活动水平（老年人身体活动量表）、生活质量（QoL）（欧洲生活质量5维度5水平问卷）以及炎症标志物（积液和 Hoffa 滑膜炎）和结构疾病进展（骨髓病变）的变化。
3个月时，两组间行走时疼痛变化无显著差异[组间差异 -0.67（95%CI -1.62，0.29）]。两组在3个月和9个月时行走时膝关节疼痛和总体膝关节疼痛均显著降低。两组在3个月和9个月时身体功能和生活质量均有所改善。我们在任何时间的任何次要结局中均未发现组间差异。
对于胫股内侧骨关节炎患者，在运动疗法中添加FFF与传统的SSS和运动相比，并未提供额外更好的症状缓解或结构改善益处。
ClinicalTrials.gov（http://clinicaltrials.gov），NCT03796832。
