Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.
La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia; Discipline of Physiotherapy, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria, 3086, Australia.
Osteoarthritis Cartilage. 2021 Apr;29(4):480-490. doi: 10.1016/j.joca.2021.02.002. Epub 2021 Feb 12.
To evaluate the efficacy of carbon-fibre shoe-stiffening inserts in individuals with first metatarsophalangeal joint osteoarthritis.
This was a randomised, sham-controlled, participant- and assessor-blinded trial. One hundred participants with first metatarsophalangeal joint osteoarthritis received rehabilitation therapy and were randomised to receive either carbon fibre shoe-stiffening inserts (n = 49) or sham inserts (n = 51). The primary outcome measure was the Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks.
All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women) were included in the analysis of the primary outcome. At the 12 week primary endpoint, there were 13 drop-outs (7 in the sham insert group and 6 in the shoe-stiffening insert group), giving completion rates of 86 and 88%, respectively. Both groups demonstrated improvements in the FHSQ pain domain score at each follow-up period, and there was a significant between-group difference in favour of the shoe-stiffening insert group (adjusted mean difference of 6.66 points, 95% CI 0.65 to 12.67, P = 0.030). There were no between-group differences for the secondary outcomes, although global improvement was more common in the shoe-stiffening insert group compared to the sham insert group (61 vs 34%, RR 1.73, 95% CI 1.05 to 2.88, P = 0.033; number needed to treat 4, 95% CI 2 to 16).
Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks. These results support the use of shoe-stiffening inserts for the management of this condition, although due to the uncertainty around the effect on the primary outcome, some individuals may not experience a clinically worthwhile improvement.
评估碳纤维鞋跟加强垫在第一跖趾关节骨关节炎患者中的疗效。
这是一项随机、假对照、参与者和评估者双盲试验。100 例第一跖趾关节骨关节炎患者接受康复治疗，并随机分为碳纤维鞋跟加强垫组（n=49）或假垫组（n=51）。主要结局测量指标为 12 周时足部健康状况问卷（FHSQ）疼痛域评分。
所有 100 名随机参与者（平均年龄 57.5（10.3）岁；55 名（55%）女性）均纳入主要结局分析。在 12 周的主要终点，有 13 名脱落者（假垫组 7 名，鞋跟加强垫组 6 名），完成率分别为 86%和 88%。两组在每个随访期间 FHSQ 疼痛域评分均有改善，鞋跟加强垫组有显著的组间差异（调整后的平均差异为 6.66 分，95%CI 0.65 至 12.67，P=0.030）。次要结局无组间差异，但与假垫组相比，鞋跟加强垫组的整体改善更为常见（61%比 34%，RR 1.73，95%CI 1.05 至 2.88，P=0.033；需要治疗的人数为 4，95%CI 2 至 16）。
在 12 周时，碳纤维鞋跟加强垫比假垫更能有效减轻足部疼痛。这些结果支持使用鞋跟加强垫来治疗这种疾病，尽管由于主要结局的效果存在不确定性，一些人可能不会经历有临床意义的改善。
