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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
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 con...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10579183/ https://www.ncbi.nlm.nih.gov/pubmed/37414460 http://dx.doi.org/10.1136/bjsports-2023-106948 |
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author | Riel, Henrik Vicenzino, Bill Olesen, Jens Lykkegaard Bach Jensen, Martin Ehlers, Lars Holger Rathleff, Michael Skovdal |
author_facet | Riel, Henrik Vicenzino, Bill Olesen, Jens Lykkegaard Bach Jensen, Martin Ehlers, Lars Holger Rathleff, Michael Skovdal |
author_sort | Riel, Henrik |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10579183 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-105791832023-10-18 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 Riel, Henrik Vicenzino, Bill Olesen, Jens Lykkegaard Bach Jensen, Martin Ehlers, Lars Holger Rathleff, Michael Skovdal Br J Sports Med Original Research 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. BMJ Publishing Group 2023-09 2023-07-06 /pmc/articles/PMC10579183/ /pubmed/37414460 http://dx.doi.org/10.1136/bjsports-2023-106948 Text en © 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. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Riel, Henrik Vicenzino, Bill Olesen, Jens Lykkegaard Bach Jensen, Martin Ehlers, Lars Holger Rathleff, Michael Skovdal 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10579183/ https://www.ncbi.nlm.nih.gov/pubmed/37414460 http://dx.doi.org/10.1136/bjsports-2023-106948 |
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