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Clinical Trial Summary

The purpose of this trial is to investigate the efficacy of fundamental patient advice and a heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy after 12 weeks.


Clinical Trial Description

This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a 3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial is done in accordance with the PREPARE Trial guide. Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1) into 3 parallel groups of 60 participants using a random number generator on www.sealedenvelope.com. The block sizes will be random and concealed to the research assistants responsible of including participants. Group allocation will be coded, and the data analyst will be blinded to this code until after the analyses have been performed. The investigators will only conclude superiority of one intervention over the other if the intention-to-treat analysis leads to mean between-group differences of the Foot Health Status Questionnaire pain domain ≥14 points (minimally important difference) and P-values <0.05 at the primary endpoint (12 weeks) after adjustment for the baseline value. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03804008
Study type Interventional
Source Aalborg University
Contact
Status Completed
Phase N/A
Start date February 7, 2019
Completion date September 23, 2021

See also
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Completed NCT03304353 - Efficacy of a Self-managed Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy N/A
Completed NCT03535896 - Heavy-slow Resistance Training and Ultrasound-guided Corticosteroid Injection in Plantar Fasciopathy N/A
Terminated NCT01588730 - Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy Phase 4
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