Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial
| Autor: | Shannon E. Munteanu, Jodie A. McClelland, Alan Shiell, Karl B Landorf, Maria Auhl, Edward Roddy, Andrew K. Buldt, Hylton B. Menz, Flavia M. Cicuttini, Jamie J. Allan |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Adult Male Metatarsophalangeal Joint medicine.medical_specialty medicine.medical_treatment Biomedical Engineering Foot Orthoses Osteoarthritis 03 medical and health sciences Young Adult 0302 clinical medicine Primary outcome RC925 Rheumatology Carbon Fiber Surveys and Questionnaires Clinical endpoint medicine Humans Orthopedics and Sports Medicine Aged Pain Measurement 030203 arthritis & rheumatology Aged 80 and over Rehabilitation business.industry R735 Mean age Middle Aged medicine.disease Foot health status questionnaire 030104 developmental biology Treatment Outcome Physical therapy Number needed to treat Female business RA Foot (unit) |
| Zdroj: | Osteoarthritis and cartilage. 29(4) |
| ISSN: | 1522-9653 |
| Popis: | OBJECTIVE: To evaluate the efficacy of carbon-fibre shoe-stiffening inserts in individuals with first metatarsophalangeal joint osteoarthritis. \ud \ud DESIGN: 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. \ud \ud RESULTS: 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). \ud \ud CONCLUSION: 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. |
| Databáze: | OpenAIRE |
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