目的:为了评估使用适应人字拖的定制鞋垫对疼痛强度的影响,足部功能,和功能性步行能力在短期和中期内持续足底足跟疼痛的个体。
方法:随机对照试验。
方法:翻板凉鞋治疗持续性足底足跟痛患者。
方法:参与者(n=80)在基线时进行评估,干预后6周和12周,干预后4周。
结果:对于主要结果,经过6周的干预,在晨痛或行走疼痛的强度方面没有观察到组间差异,平均差=-0.4(95%置信区间=-1.5至0.8)。同样,经过12周的干预,在晨痛或行走疼痛的强度方面没有观察到组间差异,平均差=-0.7(95%置信区间=-1.9至0.6)。最后,在干预结束后4周,晨间疼痛或行走疼痛没有组间差异,平均差=0.01(95%置信区间=-1.4至1.4)。所有差异和置信区间均小于疼痛的最小临床重要差异(2分)。两组之间的次要结局没有差异。此外,平均差异小于疼痛强度的最小临床重要差异,足部功能和功能性行走能力。
结论:适合人字拖的定制鞋垫在改善疼痛强度方面与带有假鞋垫的人字拖没有区别,持续足跟疼痛患者的足部功能和功能性行走能力。试验注册:ClinicalTrials.gov(标识符:NCT04784598)。注册数据:2023-01-20。
OBJECTIVE: To evaluate the use of custom-made insoles adapted to flip-flops on pain intensity, foot function, and functional walking ability in individuals with persistent plantar heel pain in the short and medium term.
METHODS: Randomised controlled trial.
METHODS: Flip-flop sandals in patients with persistent plantar heel pain.
METHODS: Participants (n = 80) were assessed at baseline, six and 12 weeks after the intervention, and 4 weeks post-intervention.
RESULTS: For the primary outcomes, after 6 weeks of intervention, no between-group difference was observed in the intensity of morning pain or pain with walking, mean difference = -0.4 (95% confidence intervals = -1.5 to 0.8). Similarly, after 12 weeks of intervention, no between-group difference was observed in the intensity of morning pain or pain with walking, mean difference = -0.7 (95% confidence intervals = -1.9 to 0.6). Finally, at 4 weeks after the end of the intervention, there was no between-group difference in morning pain or pain on walking, mean difference = 0.01 (95% confidence intervals = -1.4 to 1.4). All differences and confidence intervals were smaller than the minimum clinically important difference for pain (2 points). There were no differences between the groups for the secondary outcomes. In addition, the mean differences were smaller than the minimum clinically important differences for pain intensity, foot function and functional walking ability.
CONCLUSIONS: Custom-made insoles fitted to flip-flops did not differ from flip-flops with sham insoles in improving pain intensity, foot function and functional walking ability in people with persistent heel pain.Trial registration: ClinicalTrials.gov (Identifier: NCT04784598). Data of registration: 2023-01-20.