Bartholdy Cecilie, Døssing Anna, Stisen Zara R, Nielsen Sabrina M, Christensen Robin, Danneskiold-Samsøe Bente, Bliddal Henning, Henriksen Marius, Ellegaard Karen
The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Copenhagen, Denmark
The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Copenhagen, Denmark.
BMJ. 2024 Dec 17;387:e078222. doi: 10.1136/bmj-2023-078222.
To assess the effect of electrically heated mittens on physical hand function in people with osteoarthritis of the hands compared with control mittens.
Randomised controlled trial.
Osteoarthritis outpatient clinic, Copenhagen, Denmark.
200 people with hand osteoarthritis aged 42-90 years. 100 participants were assigned to the intervention group and 100 to the control group.
Electrically heated mittens or control mittens (heating elements disconnected) worn for at least 15 minutes daily for six weeks.
The primary outcome was change in hand function measured on the function subscale of the Australian/Canadian hand osteoarthritis index (AUSCAN; score 0-100 points) at six weeks. Key secondary outcomes included changes in the AUSCAN hand pain subscale (score 0-100 points), global rating of hand osteoarthritis related problems (0-100 visual analogue scale), and grip strength (newtons) at six weeks. Analysis of secondary outcomes was performed using a hierarchical gatekeeping approach.
91 participants in the intervention group and 95 in the control group completed the trial. The mean age of participants was 71 years, 87% (n=173) were women, and mean body mass index was 24.9 (SD 4.4). Median disease duration was 10 years (interquartile range 5-15 years). The between group difference for change in AUSCAN function at week 6 was 3.0 points (95% confidence interval (CI) -0.4 to 6.3; P=0.09) in favour of heated mittens. For the key secondary outcome, change in AUSCAN hand pain score from baseline, a group difference was observed of 5.9 points (95% CI 2.2 to 9.5) in favour of heated mittens. Changes in global rating of hand osteoarthritis related problems and grip strength did not differ between the groups with an observed difference between groups of 2.8 points (95% CI -3.7 to 9.2) and 2.3 newtons (95% CI -16.3 to 21.0) in favour of heated mittens, respectively.
Use of electrically heated mittens for six weeks was not related to a positive change in physical hand function compared with control mittens. Heated mittens provided no additional benefits on global rating of hand osteoarthritis related problems and grip strength. A small benefit was detected for hand pain, but this could have been overestimated.
ClinicalTrials.gov NCT04576403.
与对照手套相比,评估电加热手套对手部骨关节炎患者手部物理功能的影响。
随机对照试验。
丹麦哥本哈根的骨关节炎门诊。
200名年龄在42 - 90岁的手部骨关节炎患者。100名参与者被分配到干预组,100名被分配到对照组。
每天佩戴电加热手套或对照手套(加热元件断开)至少15分钟,持续六周。
主要结局是六周时根据澳大利亚/加拿大手部骨关节炎指数(AUSCAN;评分0 - 100分)功能子量表测量的手部功能变化。关键次要结局包括六周时AUSCAN手部疼痛子量表(评分0 - 100分)的变化、手部骨关节炎相关问题的总体评分(0 - 100视觉模拟量表)以及握力(牛顿)。次要结局的分析采用分层把关方法。
干预组91名参与者和对照组95名参与者完成了试验。参与者的平均年龄为71岁,87%(n = 173)为女性,平均体重指数为24.9(标准差4.4)。疾病中位持续时间为10年(四分位间距5 - 15年)。第6周时,AUSCAN功能变化的组间差异为3.0分(95%置信区间(CI)-0.4至6.3;P = 0.09),电加热手套组更优。对于关键次要结局,即AUSCAN手部疼痛评分相对于基线的变化,观察到组间差异为5.9分(95% CI 2.2至9.5),电加热手套组更优。手部骨关节炎相关问题总体评分和握力的变化在两组间无差异,观察到的组间差异分别为2.8分(95% CI -3.7至9.2)和2.3牛顿(95% CI -16.3至21.0),均为电加热手套组更优。
与对照手套相比