NCT03804008

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plantar Fasciopathy

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2019-02-07
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2019-01-15
• Last updated: 2022-01-11

Locations

1 site across 1 country: Denmark