Abstract
ObjectiveTo compare the effectiveness of patient advice plus heel cup alone (PA) versus PA and lower limb exercise (PAX) versus PAX plus corticosteroid injection (PAXI) to improve self-reported pain in patients with plantar fasciopathy.MethodsWe recruited 180 adults with plantar fasciopathy confirmed by ultrasonography for this prospectively registered three-armed, randomised, single-blinded superiority trial. Patients were randomly allocated to PA (n=62), PA plus self-dosed lower limb heavy–slow resistance training consisting of heel raises (PAX) (n=59), or PAX plus an ultrasound-guided injection of 1 mL triamcinolone 20 mg/mL (PAXI) (n=59). The primary outcome was changed in the pain domain of the Foot Health Status Questionnaire (ranging from 0 ‘worst’ to 100 ‘best’) from baseline to the 12-week follow-up. The minimal important difference in the pain domain is 14.1 points. The outcome was collected at baseline and at 4, 12, 26, and 52 weeks.ResultsThe primary analysis found a statistically significant difference between PA and PAXI after 12 weeks favouring PAXI (adjusted mean difference: −9.1 (95% CI −16.8 to −1.3; p=0.023)) and over 52 weeks (adjusted mean difference: −5.2 (95% CI −10.4 to −0.1; p=0.045)). At no follow-up did the mean difference between groups exceed the pre-specified minimal important difference. No statistically significant difference was found between PAX and PAXI or between PA and PAX at any time.ConclusionNo clinically relevant between-group differences were found after 12 weeks. The results indicate that combining a corticosteroid injection with exercise is not superior to exercise or no exercise.Trial registration numberNCT03804008.
Funder
Danmarks Frie Forskningsfond
Danish Committee of Multipractice Studies in General Practice
The Danish General Practice Foundation
Foundation for Professional Development in Specialty Doctoral Practices
Subject
Physical Therapy, Sports Therapy and Rehabilitation,Orthopedics and Sports Medicine,General Medicine
Cited by
2 articles.
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