Advice vs Advice + Exercise vs Advice + Exercise + Injection for Individuals With Plantar Fasciopathy (FIX-Heel)

Aalborg University

Status: Completed

Conditions: Plantar Fasciopathy

Treatments: Other: Fundamental advice and a silicone heel cup; Other: Heavy-slow resistance training; Drug: Ultrasound-guided corticosteroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03804008

N-20180066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of inferior heel pain for at least three months before enrolment
• pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia
• thickness of the plantar fascia of 4.0 mm or greater as measured by ultrasonography
• mean heel pain of ≥30 mm on a 100 mm VAS during the previous week

Exclusion criteria

• below 18 years of age
• diabetes
• history of inflammatory systemic diseases
• pregnancy or breastfeeding
• corticosteroid injection for plantar fasciopathy within the previous six months
• pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
• known hypersensitivity to corticosteroids or local anaesthetics
• skin or soft tissue infection near the injection site
• received treatment by a healthcare professional for plantar fasciopathy within the previous 12 weeks
• made any substantial changes to usual self-care of the condition in the last 4 weeks (e.g. started using insoles, started performing stretching, made a substantial decrease in physical activity level)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Fundamental advice and a heel cup

Active Comparator group

Treatment:

Other: Fundamental advice and a silicone heel cup

Fundamental advice and a heel cup plus exercise

Active Comparator group

Treatment:

Other: Fundamental advice and a silicone heel cup

Other: Heavy-slow resistance training

Fundamental advice and a heel cup plus exercise and injection

Active Comparator group

Treatment:

Drug: Ultrasound-guided corticosteroid injection

Other: Fundamental advice and a silicone heel cup

Other: Heavy-slow resistance training