Heavy-slow Resistance Training and Ultrasound-guided Corticosteroid Injection in Plantar Fasciopathy

NCT03535896 | Completed

• 1 other identifier: 2018-521-0008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the feasibility of combining heavy-slow resistance training with an ultrasound-guided corticosteroid injection to reduce pain in individuals with plantar fasciopathy. Feasibility will be evaluated using the acceptability of the combined interventions and exercise compliance.

Conditions

Plantar Heel Pain; Plantar Fasciopathy

Outcome Measures

Primary Outcomes (4)

• Acceptability

  Acceptability of the combined interventions measured by a participant acceptability questionnaire that includes a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the participant's symptoms have improved to a point where they are recovered or feel close to recovery but if it matches their expectations to the content of the intervention and acceptability of performing exercise after receiving an injection. This will be clearly stated on the questionnaire to emphasise that improvement is not to be considered. The combined interventions are categorised as "unacceptable" if they are rated as "very unacceptable" or "unacceptable" (category 1-2) and categorised as "acceptable" if they are rated from "slightly unacceptable" to "very acceptable" (category 3-7).

  At the 8-week follow-up

• Compliance

  Compliance to the exercises as measured by the mean number of training sessions performed per week throughout the intervention measured by a training diary that each participant is handed out at baseline. The participants will be instructed in filling out the number of repetitions and sets performed and the day on which they performed the exercise

  From baseline to the 8-week follow-up

• Recruitment rate

  Mean number of participants recruited per week

  From start of recruitment until the 20th participant has been recruited, assessed up to 12 months

• Exercise start

  Mean days until the participant starts to perform the exercises from the two days after the injection based on training diary data. Participants are asked to start performing the exercise as soon as they feel ready but not before two days after the injection.

  From date of injection to exercise start assessed up to 8 weeks

Secondary Outcomes (6)

• Change in Foot Health Status Questionnaire

  At baseline and at the 4- and 8-week follow-ups

• Change in mean daily heel pain measured on an 11-point Numerical Rating Scale (NRS)

  From baseline to one week after injection

• Global Rating of Change

  At the 8-week follow-up

• Change in plantar fascia thickness

  At baseline and at the 8-week follow-up

• Change in Pain Self-Efficacy Questionnaire score

  At baseline and at the 4- and 8-week follow-ups

Study Arms (1)

HSR and injection

EXPERIMENTAL

HSR and corticosteroid injection

Other: HSR; Drug: Corticosteroid injection

Interventions

HSR OTHER

Participants will complete a heel raise standing with the forefoot on a step. The toes are maximally dorsiflexed by placing a towel underneath them. The heel raise is performed with a raise to maximal plantar flexion and to maximal dorsi flexion. The exercise is performed with a load as heavy as possible but no heavier than 8RM and for as many sets as possible every other day.

HSR and injection

Corticosteroid injection DRUG

Participants receive an ultrasound-guided corticosteroid injection between 5 and 8 days after baseline. A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid (Lederspan, Meda) + 1 ml Lidocain 10 mg7ml (Xylocain, AstraZeneca). The skin is cleansed with Chlorhexidine alcohol 0.5 % (Medic). 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.

HSR 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 mm or greater
• Mean heel pain of 30 mm or above on a 0 to 100 mm VAS during the previous week

You may not qualify if:

• Below 18 years of age
• History of inflammatory systemic diseases
• Prior heel surgery
• Pregnancy
• Pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
• Corticosteroid injection for plantar fasciopathy within the previous six months
• Known hypersensitivity to corticosteroids or local anaesthetics
• Skin or soft tissue infection near the injection site

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (1)

• Riel H, Olesen JL, Jensen MB, Vicenzino B, Rathleff MS. Heavy-slow resistance training in addition to an ultrasound-guided corticosteroid injection for individuals with plantar fasciopathy: a feasibility study. Pilot Feasibility Stud. 2019 Aug 24;5:105. doi: 10.1186/s40814-019-0489-3. eCollection 2019.

  PMID: 31463078 DERIVED

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Henrik Riel, MSc

  Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 24, 2018
• Study Start: June 8, 2018
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

DK (1)