TY - JOUR
T1 - Does a corticosteroid injection plus exercise or exercise alone add to the effect of patient advice and a heel cup for patients with plantar fasciopathy? A randomised clinical trial
AU - Riel, Henrik
AU - Vicenzino, Bill
AU - Olesen, Jens Lykkegaard
AU - Jensen, Martin Bach
AU - Ehlers, Lars Holger
AU - Rathleff, Michael Skovdal
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/9
Y1 - 2023/9
N2 - Objective: To 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. Methods: We 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. Results: The 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. Conclusion: No 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 number: NCT03804008.
AB - Objective: To 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. Methods: We 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. Results: The 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. Conclusion: No 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 number: NCT03804008.
UR - http://www.scopus.com/inward/record.url?scp=85166401303&partnerID=8YFLogxK
U2 - 10.1136/bjsports-2023-106948
DO - 10.1136/bjsports-2023-106948
M3 - Journal article
C2 - 37414460
SN - 0306-3674
VL - 57
SP - 1180
EP - 1186
JO - British Journal of Sports Medicine
JF - British Journal of Sports Medicine
IS - 18
ER -