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

NCT03804008 | Completed

• 1 other identifier: N-20180066
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Foot Health Status Questionnaire function domain

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

• Change in Foot Health Status Questionnaire footwear domain

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

• Change in Foot Health Status Questionnaire general foot health domain

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

• Global Rating of Change

  At follow-ups after 12, 26 and 52 weeks

• Time to Patient Acceptable Symptom State

  From 0 to 52 weeks

Other Outcomes (2)

• Sick leave

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

• Condition-related expenses

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

Study Arms (3)

Fundamental advice and a heel cup

ACTIVE COMPARATOR

Other: Fundamental advice and a silicone heel cup

Fundamental advice and a heel cup plus exercise

ACTIVE COMPARATOR

Other: Heavy-slow resistance training; Other: Fundamental advice and a silicone heel cup

Fundamental advice and a heel cup plus exercise and injection

ACTIVE COMPARATOR

Drug: Ultrasound-guided corticosteroid injection; Other: Heavy-slow resistance training; Other: Fundamental advice and a silicone heel cup

Interventions

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.

Fundamental advice and a heel cup plus exercise and 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 heel cup plus exercise; Fundamental advice and a heel cup plus exercise and injection

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.

Fundamental advice and a heel cup; Fundamental advice and a heel cup plus exercise; Fundamental advice and a heel cup plus exercise and injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Department of occupational therapy and physiotherapy, Aalborg University Hospital

Hobrovej 18-22, 9000, Denmark

Location

Related Publications (2)

• Riel H, Vicenzino B, Olesen JL, Bach Jensen M, Ehlers LH, Rathleff MS. Does a corticosteroid injection plus exercise or exercise alone add to the effect of patient advice and a heel cup for patients with plantar fasciopathy? A randomised clinical trial. Br J Sports Med. 2023 Sep;57(18):1180-1186. doi: 10.1136/bjsports-2023-106948. Epub 2023 Jul 6.

  PMID: 37414460 DERIVED

• 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.

  PMID: 31898517 DERIVED

Study Officials

• Michael S Rathleff, PhD

  Aalborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Analyses will be carried out by a blinded data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: February 7, 2019
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

DK (1)