NCT03264729

Brief Summary

This study investigates the acute effect of isotonic versus isometric exercise versus walking on pain in individuals with plantar heel pain and an ultrasound-diagnosed plantar fasciopathy. The hypothesis is that isometric exercise will induce greater participant rated pain relief than isotonic exercise and walking during aggravating activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

August 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

1 month

First QC Date

August 15, 2017

Last Update Submit

October 4, 2017

Conditions

Keywords

plantar heel pain

Outcome Measures

Primary Outcomes (1)

  • Change in pain

    This is measured during an aggravating task on a 100 mm VAS, where 0 mm is no pain and 100 mm is worst pain imaginable and is also referred to as exercise-induced hypoalgesia (EIH)

    Immediately before and after each exercise/walking

Secondary Outcomes (3)

  • Change in pressure pain threshold

    Immediately before and after each exercise/walking

  • Change in thickness of the plantar fascia

    Immediately before and after each exercise/walking

  • Pain

    During each exercise/walking

Study Arms (3)

Isometric exercise

EXPERIMENTAL
Other: Isometric exercise

Isotonic exercise

ACTIVE COMPARATOR
Other: Isotonic exercise

Walking

ACTIVE COMPARATOR
Other: Walking

Interventions

The isometric exercise is performed standing with the forefoot on a step. The participant is instructed to stand still with the ankle joint in neutral and hold this position. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 5 sets of 45-second isometric holds. The load used is the heaviest possible load that the participant is able to withstand for 1 minute. As with the isotonic exercise, if the participant's body weight is inadequate the participant is fitted with a backpack with books and/or weights.

Isometric exercise

The isotonic exercise is performed 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 a maximal plantar flexion in the ankle joint, and afterwards to lower the heel to maximal dorsi flexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 4 sets of 8 repetitions with a load of 8RM. The contraction time is 3s concentric, 2s isometric and 3s eccentric and will be guided by a metronome. If the participant's body weight is inadequate to reach sufficient loading during the exercises the participant is fitted with a backpack with books and/or weights.

Isotonic exercise
WalkingOTHER

The walking will be performed barefoot and the participant will be instructed in walking at a pace similar to the pace they would use when walking around in their home. The duration of the walking session will be four minutes to match the duration during the exercises.

Walking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Pain during at least one of three pain aggravating activities (static stance, half squat and heel raise)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice

Aalborg East, 9220, Denmark

Location

Related Publications (1)

  • Riel H, Vicenzino B, Jensen MB, Olesen JL, Holden S, Rathleff MS. The effect of isometric exercise on pain in individuals with plantar fasciopathy: A randomized crossover trial. Scand J Med Sci Sports. 2018 Dec;28(12):2643-2650. doi: 10.1111/sms.13296. Epub 2018 Oct 1.

MeSH Terms

Interventions

ExerciseWalking

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 29, 2017

Study Start

August 24, 2017

Primary Completion

October 3, 2017

Study Completion

October 3, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations