Efficacy of a Self-managed Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy

NCT03304353 | Completed

• 1 other identifier: N-20170051
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to investigate whether a self-managed resistance training protocol is more effective than a predetermined resistance training protocol in improving the Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy after a 12-week intervention.

Conditions

Plantar Fasciopathy

Keywords

Plantar heel pain; Resistance training

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 Danish translation of the original questionnaire will be used. The translation was made using a dual panel approach.

  At baseline and at the 4- and 12-week follow-ups.

Secondary Outcomes (8)

• Change in Foot Health Status Questionnaire function domain

  At baseline and at the 4- and 12-week follow-ups.

• Change in Foot Health Status Questionnaire footwear domain

  At baseline and at the 4- and 12-week follow-ups.

• Change in Foot Health Status Questionnaire general foot health domain

  At baseline and at the 4- and 12-week follow-ups.

• Global Rating of Change

  At the 12-week follow-up.

• Change in plantar fascia thickness

  At baseline and at the 4- and 12-week follow-ups.

Study Arms (2)

Self-managed protocol

EXPERIMENTAL

Other: Self-managed protocol

Predetermined protocol

ACTIVE COMPARATOR

Other: Predetermined protocol

Interventions

Self-managed protocol 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. The participants in the self-managed group 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.

Self-managed protocol

Predetermined protocol 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. The participants in the predetermined group are instructed in performing the exercise at a 12RM for three sets during week 1 and 2, at a 10RM for four sets during week 3 and 4, and at an 8RM for five sets from week 5 and onwards.

Predetermined protocol

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
• Mean heel pain of ≥ 20 mm on a 100 mm VAS \[0mm = no pain, 100mm = worst pain imaginable\] during the past week

You may not qualify if:

• Below 18 years of age
• History of inflammatory systemic diseases
• Pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
• Prior heel surgery
• Pregnancy
• Pain medication
• Corticosteroid injection for plantar fasciopathy within the past six months

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Research Unit for General Practice

Aalborg, Northern Jutland, 9220, Denmark

Location

Related Publications (1)

• Riel H, Jensen MB, Olesen JL, Vicenzino B, Rathleff MS. Self-dosed and pre-determined progressive heavy-slow resistance training have similar effects in people with plantar fasciopathy: a randomised trial. J Physiother. 2019 Jul;65(3):144-151. doi: 10.1016/j.jphys.2019.05.011. Epub 2019 Jun 13.

  PMID: 31204294 DERIVED

Study Officials

• Henrik Riel, M.Sc.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 9, 2017
• Study Start: October 12, 2017
• Primary Completion: May 17, 2018
• Study Completion: May 17, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

DK (1)