Plantar FasciopathyNCT03264729
The Acute Effect of Isotonic Versus Isometric Exercise Versus Walking on Pain in Individuals With Plantar Fasciopathy
A study testing Isometric exercise, Isotonic exercise and Walking in people with Plantar Fasciopathy, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciopathy
- What is being tested?
- Isometric exercise, Isotonic exercise and Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Aug 2017to 3 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of Isotonic Versus Isometric Exercise Versus Walking on Pain in Individuals With Plantar Fasciopathy: a Randomised, Participant-blinded, Cross-over Trial
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.
Read the detailed description
Participants will be required to attend three sessions (isometric, isotonic, or walking) within a maximum of two weeks. The order in which the participant completes the sessions will be randomised.There will be a minimum of 48 hours between sessions. To account for potential time of day differences in terms of pain, all sessions will be performed within ±1 hour (e.g. if the first session is performed at 10 AM the remaining two sessions will be performed between 9 and 11 AM). After diagnosis, randomisation of the order of which the sessions will be performed, and have their pain during an aggravating activity examined (aggravating activities will be static stance, half squat or heel raise). Subsequently the participants will be instructed in performing either isotonic or isometric heel raise or walking, (determined according to the randomisation) by a physiotherapist.
All statistical analyses will be performed according to a pre-established analysis plan using STATA ver. 14. The assumption of negligible carryover effects is investigated with a preliminary test. The primary analysis will test the presence of a difference in EIH between isotonic and isometric exercise and walking and a 3 X 2 repeated measures ANOVA will be performed. Independent factors will be exercise type (isometric vs. isotonic vs. walking) and time (pre vs. post). If an interaction is found, post-hoc paired t-tests will be performed. The standardised mean difference (effect size) and its confidence intervals will be calculated and presented in a forest plot. Apriori it has been determined that no conclusions will be made favouring either of the exercises nor walking if pain is reduced less than the clinically important difference of 19 mm VAS. In addition, the proportion of clinically relevant pain reductions (i.e. a pain reduction of at least 19 mm VAS) will be calculated. EIH by pain experienced during the aggravating activity before the exercises and walking will also be presented in a plot.
Secondary analyses using a 3 X 2 repeated measures ANOVAs will test if there is a difference in the thickness of the plantar fascia and a difference in PPTs from before to after either of the exercises or walking and a difference in pain experienced during the exercises or walking. If interactions are found post-hoc paired t-tests will be performed. A paired t-test will be performed to investigate potential differences in plantar fascia thickness from before to after the initial PPT and pain aggravating activity are performed. Effect sizes will be calculated for the difference in pressure pain threshold and plantar fascia thickness. The association between thickness of the plantar fascia and the difference in pain from before to after the exercise activities will be investigated using Pearson's correlation coefficient.
- Conditions
- Plantar Fasciopathy
- Being tested
- Isometric exercise, Isotonic exercise, Walking
- Keywords
- plantar heel pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseOther
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.
Isotonic exerciseOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise | Experimental | Not described Receives: Other: Isometric exercise |
| Isotonic exercise | Active comparator | Not described Receives: Other: Isotonic exercise |
| Walking | Active comparator | Not described Receives: Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately before and after each exercise/walking
Secondary outcomes (3)
Change in pressure pain threshold
Measured on the tenderest spot under the heel by an algometer in kPa
Measured: Immediately before and after each exercise/walking
Change in thickness of the plantar fascia
Measured by ultrasonography in mm
Measured: Immediately before and after each exercise/walking
Pain
Measured on a 100 mm VAS, where 0 mm is no pain and 100 mm is worst pain imaginable.
Measured: During each exercise/walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start24 Aug 2017
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Riel, Aalborg University
- Investigators
- Henrik Riel, M.Sc., Principal investigator, Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264729
- Sponsor's protocol ID
- N-20170021
- Status last verified
- Oct 2017
- First submitted
- 15 Aug 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30203866
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Isotonic Versus Isometric Exercise Versus Walking on Pain in Individuals With Plantar Fasciopathy: a Randomised, Participant-blinded, Cross-over Trial
- ClinicalTrials.gov ID
- NCT03264729
- Acronym / sponsor ID
- N-20170021
- Conditions
- Plantar Fasciopathy
- Keywords
- plantar heel pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be required to attend three sessions (isometric, isotonic, or walking) within a maximum of two weeks. The order in which the participant completes the sessions will be randomised.There will be a minimum of 48 hours between sessions. To account for potential time of day differences in terms of pain, all sessions will be performed within ±1 hour (e.g. if the first session is performed at 10 AM the remaining two sessions will be performed between 9 and 11 AM). After diagnosis, randomisation of the order of which the sessions will be performed, and have their pain during an aggravating activity examined (aggravating activities will be static stance, half squat or heel raise). Subsequently the participants will be instructed in performing either isotonic or isometric heel raise or walking, (determined according to the randomisation) by a physiotherapist.
All statistical analyses will be performed according to a pre-established analysis plan using STATA ver. 14. The assumption of negligible carryover effects is investigated with a preliminary test. The primary analysis will test the presence of a difference in EIH between isotonic and isometric exercise and walking and a 3 X 2 repeated measures ANOVA will be performed. Independent factors will be exercise type (isometric vs. isotonic vs. walking) and time (pre vs. post). If an interaction is found, post-hoc paired t-tests will be performed. The standardised mean difference (effect size) and its confidence intervals will be calculated and presented in a forest plot. Apriori it has been determined that no conclusions will be made favouring either of the exercises nor walking if pain is reduced less than the clinically important difference of 19 mm VAS. In addition, the proportion of clinically relevant pain reductions (i.e. a pain reduction of at least 19 mm VAS) will be calculated. EIH by pain experienced during the aggravating activity before the exercises and walking will also be presented in a plot.
Secondary analyses using a 3 X 2 repeated measures ANOVAs will test if there is a difference in the thickness of the plantar fascia and a difference in PPTs from before to after either of the exercises or walking and a difference in pain experienced during the exercises or walking. If interactions are found post-hoc paired t-tests will be performed. A paired t-test will be performed to investigate potential differences in plantar fascia thickness from before to after the initial PPT and pain aggravating activity are performed. Effect sizes will be calculated for the difference in pressure pain threshold and plantar fascia thickness. The association between thickness of the plantar fascia and the difference in pain from before to after the exercise activities will be investigated using Pearson's correlation coefficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise | Experimental | Other: Isometric exercise |
| Isotonic exercise | Active comparator | Other: Isotonic exercise |
| Walking | Active comparator | Other: Walking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exerciseThe 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. | Other | Isometric exercise |
| Isotonic exerciseThe 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. | Other | Isotonic exercise |
| WalkingThe 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. | Other | Walking |
Primary outcome
Change in pain
Time frame: Immediately before and after each exercise/walking
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)
3 secondary outcomes
Change in pressure pain threshold
Time frame: Immediately before and after each exercise/walking
Change in thickness of the plantar fascia
Time frame: Immediately before and after each exercise/walking
Pain
Time frame: During each exercise/walking
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Derived from this study: PubMed 30203866Riel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Riel, M.Sc. principal investigator
Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise, Isotonic exercise and Walking in people with Plantar Fasciopathy, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain (time frame: Immediately before and after each exercise/walking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.