Postgraduate Program in Rehabilitation Sciences, School of Health Sciences of Trairi, Universidade Federal do Rio Grande do Norte, Santa Cruz, RN, Brazil.
Universidade Cidade de São Paulo, São Paulo, SP, Brazil.
Clin Rehabil. 2024 Nov;38(11):1466-1480. doi: 10.1177/02692155241267991. Epub 2024 Aug 2.
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.
Randomised controlled trial.
Flip-flop sandals in patients with persistent plantar heel pain.
Participants (n = 80) were assessed at baseline, six and 12 weeks after the intervention, and 4 weeks post-intervention.
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.
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. ClinicalTrials.gov (Identifier: NCT04784598). Data of registration: 2023-01-20.
评估在短期内和中期内，将定制的适合人字拖的鞋垫应用于人字拖在缓解持续性足跟痛患者的疼痛强度、足部功能和功能性步行能力方面的效果。
随机对照试验。
在患有持续性足跟痛的患者中使用人字拖。
参与者（n=80）在基线、干预后 6 周和 12 周以及干预后 4 周进行评估。
对于主要结局，在干预 6 周后，两组间早晨疼痛或行走时疼痛的强度没有差异，平均差异=-0.4（95%置信区间=-1.5 至 0.8）。同样，在干预 12 周后，两组间早晨疼痛或行走时疼痛的强度没有差异，平均差异=-0.7（95%置信区间=-1.9 至 0.6）。最后，在干预结束后 4 周，两组间早晨疼痛或行走时疼痛的强度没有差异，平均差异=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）。两组间在次要结局方面没有差异。此外，平均差异小于疼痛强度、足部功能和功能性步行能力的最小临床重要差异。
与人字拖内置假鞋垫相比，定制的适合人字拖的鞋垫在改善持续性足跟痛患者的疼痛强度、足部功能和功能性步行能力方面没有差异。ClinicalTrials.gov（标识符：NCT04784598）。注册数据：2023 年 1 月 20 日。
