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Completed

NCT Number: NCT03804008

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

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.

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Key information

Conditions

Plantar Fasciopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of occupational therapy and physiotherapy, Aalborg University Hospital

Hobrovej 18-22, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ultrasound-guided corticosteroid injection

Drug

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.

Heavy-slow resistance training

Other

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.

Fundamental advice and a silicone heel cup

Other

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.

Primary outcomes

  1. Change in Foot Health Status Questionnaire pain domain

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    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.

Secondary outcomes

  1. Change in Foot Health Status Questionnaire function domain

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    Ranging from 0 (poor foot health) to 100 (optimum foot health)

  2. Change in Foot Health Status Questionnaire footwear domain

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    Ranging from 0 (poor foot health) to 100 (optimum foot health)

  3. Change in Foot Health Status Questionnaire general foot health domain

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    Ranging from 0 (poor foot health) to 100 (optimum foot health)

  4. Global Rating of Change

    Time frame: At follow-ups after 12, 26 and 52 weeks

    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)

  5. Time to Patient Acceptable Symptom State

    Time frame: From 0 to 52 weeks

    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

  6. Change in Pain Self-Efficacy Questionnaire score

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    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

  7. Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents

    Time frame: Week 1 and Week 13 of the interventions

    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.

  8. Change in self-reported health state as measured by the EQ-5D-5L

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

Other outcomes

  1. Sick leave

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    Participants are asked how many days of sick leave they have had during the past 4 weeks due to their condition

  2. Condition-related expenses

    Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks

    Participants are asked which expenses and the size they have had during the past 4 weeks due to their condition

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study 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

Acronym: FIX-Heel

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2019
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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