Clinical trial NCT03804008: Advice vs Advice + Exercise vs Advice + Exercise + Injection for Individuals With Plantar Fasciopathy
Official title: The Efficacy of Fundamental Advice and a Heel Cup Versus Fundamental Advice and a Heel Cup Plus eXercise Versus Fundamental Advice and a Heel Cup Plus Exercise and a Corticosteroid Injection in Individuals With Plantar Fasciopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciopathy
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Foot Health Status Questionnaire pain domain
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Secondary outcomes:
measure: Change in Foot Health Status Questionnaire function domain
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
measure: Change in Foot Health Status Questionnaire footwear domain
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
measure: Change in Foot Health Status Questionnaire general foot health domain
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
measure: Global Rating of Change
timeFrame: At follow-ups after 12, 26 and 52 weeks
measure: Time to Patient Acceptable Symptom State
timeFrame: From 0 to 52 weeks
measure: Change in Pain Self-Efficacy Questionnaire score
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
measure: Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents
timeFrame: Week 1 and Week 13 of the interventions
measure: Change in self-reported health state as measured by the EQ-5D-5L
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Other outcomes:
measure: Sick leave
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
measure: Condition-related expenses
timeFrame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Locations:
city: Hobrovej 18-22
country: Denmark
facility: Department of occupational therapy and physiotherapy, Aalborg University Hospital
Study officials:
affiliation: Aalborg University
name: Michael S Rathleff, PhD
role: STUDY_CHAIR
References:
citation: Riel H, Vicenzino B, Olesen JL, Jensen MB, Ehlers LH, Rathleff MS. 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). Trials. 2020 Jan 2;21(1):5. doi: 10.1186/s13063-019-3977-0.