Advice vs Advice + Exercise vs Advice + Exercise + Injection for Individuals With Plantar Fasciopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Plantar Fasciopathy

Intervention / Treatment
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* Drug: Ultrasound-guided corticosteroid injection
* Other: Heavy-slow resistance training
* Other: Fundamental advice and a silicone heel cup


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fundamental advice and a heel cup<br> | Other: Fundamental advice and a silicone heel cup<br>* Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.<br>|
| Active Comparator: Fundamental advice and a heel cup plus exercise<br> | Other: Heavy-slow resistance training<br>* Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. Participants are instructed in performing the exercise with a load as heavy as possible but no higher than 8RM and for as many sets as possible every other day.<br>Other: Fundamental advice and a silicone heel cup<br>* Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.<br>|
| Active Comparator: Fundamental advice and a heel cup plus exercise and injection<br> | Drug: Ultrasound-guided corticosteroid injection<br>* A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid 20mg/ml + 1 ml Lidocain 10 mg7ml. The skin is cleansed with Chlorhexidine alcohol 0.5 %. The needle is inserted with a medial approach under ultrasound-guidance aligned to the long axis of the ultrasound transducer. The injection is placed anterior to the plantar fascia insertion on the calcaneal bone in the region of maximal fascia thickness. Participants are asked to start performing the exercise as soon as they feel ready but not before 24 hours after the injection. Furthermore, they are asked not to progress the method used to achieve 8RM when they start to do the exercise after the injection until Week 3 of the exercise programme. If standing on both feet was sufficient to achieve 8RM at baseline, the participant must not perform the exercise single-legged or to wear a backpack with weights after the injection regardless of any pain reduction afforded by the injection.<br>Other: Heavy-slow resistance training<br>* Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. Participants are instructed in performing the exercise with a load as heavy as possible but no higher than 8RM and for as many sets as possible every other day.<br>Other: Fundamental advice and a silicone heel cup<br>* Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot Health Status Questionnaire pain domain | The Foot Health Status Questionnaire is a self-report questionnaire ranging from 0 (poor foot health) to 100 (optimum foot health) that assesses multiple dimensions of foot health and function. A validated Danish translation of the original questionnaire will be used. | During baseline and at follow-ups after 4, 12, 26 and 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot Health Status Questionnaire function domain | Ranging from 0 (poor foot health) to 100 (optimum foot health) | During baseline and at follow-ups after 4, 12, 26 and 52 weeks | 
| Change in Foot Health Status Questionnaire footwear domain | Ranging from 0 (poor foot health) to 100 (optimum foot health) | During baseline and at follow-ups after 4, 12, 26 and 52 weeks | 
| Change in Foot Health Status Questionnaire general foot health domain | Ranging from 0 (poor foot health) to 100 (optimum foot health) | During baseline and at follow-ups after 4, 12, 26 and 52 weeks | 
| Global Rating of Change | This will be used to measure the participants' self-reported recovery on a 7-point Likert scale ranging from much improved to much worse. Participants are categorised as improved if they rate themselves as much improved or improved (category 6-7) and categorised as not improved if they rate themselves from slightly improved to much worse (category 1-5) | At follow-ups after 12, 26 and 52 weeks | 
| Time to Patient Acceptable Symptom State | This will be used as a measure of when participants achieve a self-evaluated satisfactory result and feels no further treatment is needed; hence, it is not necessarily a measure of complete recovery | From 0 to 52 weeks | 
| Change in Pain Self-Efficacy Questionnaire score | The Pain Self-Efficacy Questionnaire ranges from 0 (not at all confident) to 60 (completely confident) with lower scores indicating lower self-efficacy. A Danish translation of the original questionnaire, which has been validated in a Danish chronic pain population, will be used | During baseline and at follow-ups after 4, 12, 26 and 52 weeks | 
| Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents | Participants will be wearing a wrist-worn accelerometer ((ActiGraph wGT3X-BT (ActiGraph LLC, Pensacola, FL, USA)) during the first three weeks after baseline and again during the first three weeks after the 12-week follow-up. | Week 1 and Week 13 of the interventions | 
| Change in self-reported health state as measured by the EQ-5D-5L |  | During baseline and at follow-ups after 4, 12, 26 and 52 weeks |