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

Plantar Fasciopathy Clinical Trial

— FIX-Heel  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804008
• Other study ID #: N-20180066
• Status: Completed
• Phase: N/A
• Start date: February 7, 2019
• Est. completion date: September 23, 2021

Study information

• Verified date: January 2022
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 23, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Plantar Fasciopathy

Intervention

Drug:
• Ultrasound-guided corticosteroid injection
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.

Other:
• Heavy-slow resistance training
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
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.

Locations

Country	Name	City	State
Denmark	Department of occupational therapy and physiotherapy, Aalborg University Hospital	Hobrovej 18-22

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University	Center for General Practice at Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sick leave	Participants are asked how many days of sick leave they have had during the past 4 weeks due to their condition	During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Other	Condition-related expenses	Participants are asked which expenses and the size they have had during the past 4 weeks due to their condition	During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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