Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial)

TY - JOUR

T1 - Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy

T2 - protocol for a randomised clinical superiority trial (the FIX-Heel trial)

AU - Riel, Henrik

AU - Vicenzino, Bill

AU - Olesen, Jens Lykkegaard

AU - Jensen, Martin Bach

AU - Ehlers, Lars Holger

AU - Rathleff, Michael Skovdal

PY - 2020/1/2

Y1 - 2020/1/2

N2 - Background: Plantar fasciopathy has a lifetime prevalence of 10%. Patients experience sharp pain under the heel, often for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. A corticosteroid injection offers short-term pain relief but is no better than placebo in the longer term (> 8 weeks). Heavy-slow resistance training has shown potentially positive effects on long-term outcomes (> 3 months), and combining exercises with an injection may prove to be superior to exercises alone. However, the effect of heavy-slow resistance training compared with a simpler approach of patient advice (e.g., load management) and insoles is currently unknown. This trial compares the efficacy of patient advice with patient advice plus heavy-slow resistance training and with patient advice plus heavy-slow resistance training plus a corticosteroid injection in improving the Foot Health Status Questionnaire pain score after 12 weeks in patients with plantar fasciopathy. Methods: In this randomised superiority trial, we will recruit 180 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of three groups: (1) patient advice and an insole (n = 60); (2) patient advice, an insole, and self-dosed heavy-slow resistance training consisting of heel raises (n = 60); or (3) patient advice, an insole, heavy-slow resistance training, and an ultrasound-guided corticosteroid injection (n = 60). All participants will be followed for 1 year, with the 12-week follow-up considered the primary endpoint. The primary outcome is the Foot Health Status questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a 7-point Global Rating of Change, the Pain Self-Efficacy Questionnaire, physical activity level, health-related quality of life measured by the EQ-5D-5L, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment. Additionally, a health economic evaluation of the treatments will be carried out. Discussion: This trial will test if adding heavy-slow resistance training to fundamental patient advice and an insole improves outcomes and if a corticosteroid injection adds even further to that effect in patients with plantar fasciopathy. Trial registration: ClinicalTrials.gov, NCT03804008. Prospectively registered on January 15, 2019.

AB - Background: Plantar fasciopathy has a lifetime prevalence of 10%. Patients experience sharp pain under the heel, often for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. A corticosteroid injection offers short-term pain relief but is no better than placebo in the longer term (> 8 weeks). Heavy-slow resistance training has shown potentially positive effects on long-term outcomes (> 3 months), and combining exercises with an injection may prove to be superior to exercises alone. However, the effect of heavy-slow resistance training compared with a simpler approach of patient advice (e.g., load management) and insoles is currently unknown. This trial compares the efficacy of patient advice with patient advice plus heavy-slow resistance training and with patient advice plus heavy-slow resistance training plus a corticosteroid injection in improving the Foot Health Status Questionnaire pain score after 12 weeks in patients with plantar fasciopathy. Methods: In this randomised superiority trial, we will recruit 180 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of three groups: (1) patient advice and an insole (n = 60); (2) patient advice, an insole, and self-dosed heavy-slow resistance training consisting of heel raises (n = 60); or (3) patient advice, an insole, heavy-slow resistance training, and an ultrasound-guided corticosteroid injection (n = 60). All participants will be followed for 1 year, with the 12-week follow-up considered the primary endpoint. The primary outcome is the Foot Health Status questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a 7-point Global Rating of Change, the Pain Self-Efficacy Questionnaire, physical activity level, health-related quality of life measured by the EQ-5D-5L, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment. Additionally, a health economic evaluation of the treatments will be carried out. Discussion: This trial will test if adding heavy-slow resistance training to fundamental patient advice and an insole improves outcomes and if a corticosteroid injection adds even further to that effect in patients with plantar fasciopathy. Trial registration: ClinicalTrials.gov, NCT03804008. Prospectively registered on January 15, 2019.

U2 - 10.1186/s13063-019-3977-0

DO - 10.1186/s13063-019-3977-0

M3 - Journal article

C2 - 31898517

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 5

ER -