Plantar FasciopathyNCT03304353
Efficacy of a Self-managed Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy
A study testing Self-managed protocol and Predetermined protocol in people with Plantar Fasciopathy, run by Aalborg University at 1 site in Denmark.
Trial 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. 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?
- Self-managed protocol and Predetermined protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Oct 2017to 17 May 2018
- 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
- 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.
Denmark1 site
Research Unit for General Practice
Aalborg, Northern Jutland, 9220
About this study
Official title: The Efficacy of a Self-managed Resistance Training Protocol Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy During a 12-week Intervention: a Randomised Controlled Superiority Trial
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.
Read the detailed description
This trial will be designed as a randomised, participant-blinded, superiority trial, with a 2-group parallel design to be conducted in Denmark. Reporting of the trial will follow CONSORT guidelines for reporting non-pharmacologic treatments and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial was done in accordance with the PREPARE Trial guide (25).
In addition to the exercises, both groups receive patient education on their condition. They will be informed about what is known about the condition in terms of risk factors and aetiology, the pathology, activity modification, and the rationale for why their specific exercise programme (self-managed or predetermined) could lead to recovery. The participants of the predetermined group will be informed that this specific exercise and exercise programme has been found to be superior to stretching but it is important to follow the protocol as closely as possible. The participants of the self-managed group will be informed that this specific exercise has been found to be superior to stretching but based on previous research of other tendinopathies we believe that doing the exercise as heavy as possible but not heavier than 8RM and with as many sets as possible will increase the odds of recovery. Both groups are told that compliance to their protocol is very important and that compliance to the exercises are associated with their recovery. They are also informed about other types of evidence-based treatments however, they are asked to refrain from seeking other treatments during the course of the study. A silicone heel cup will be given to all participants. If the participant already uses an insole or any other type of foot orthosis they will be allowed to continue wearing this if they do not want to use the heel cup.
All statistical analyses will be performed according to a pre-established analysis plan in consultation with a statistician. STATA ver. 14 will be used as statistical software. The primary intention-to-treat analysis will test the between-group difference in the FHSQ pain domain at the 12-week follow-up. In addition to this, between-group comparisons of the other FHSQ domains, PSEQ, IPAQ, and plantar fascia thickness will be performed using a repeated measures ANCOVA with the outcome as the dependent variable, time (baseline, 4 weeks and 12 weeks) as the within-subjects factor, group allocation as the between-subjects factor and the baseline value as the covariate. If any interactions are found, post hoc Bonferroni adjustments for multiple comparisons will be made. The between-group difference in time to PASS among participants who report PASS, and the number of training sessions performed during the trial using independent t-tests. The relative risk (RR) will be calculated for the dichotomized GROC to determine the probability of being improved and for the dichotomized PASS (Yes/No) to determine the probability of achieving a satisfactory result within the 12 weeks of intervention. The difference in mean training sessions performed per week from before to after PASS among participants who report PASS no later than during week 11 of the intervention will be investigated using a paired t-test. The number needed to treat will be calculated as 1/risk difference for the primary outcome. The association between the PSEQ score and compliance will be investigated using Pearson's correlation coefficient.
- Conditions
- Plantar Fasciopathy
- Being tested
- Self-managed protocol, Predetermined protocol
- Keywords
- Plantar heel pain, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-managed protocolOther
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.
Predetermined protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-managed protocol | Experimental | Not described Receives: Other: Self-managed protocol |
| Predetermined protocol | Active comparator | Not described Receives: Other: Predetermined protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and at the 4- and 12-week follow-ups.
Secondary outcomes (8)
Change in Foot Health Status Questionnaire function domain
Ranging from 0 (poor foot health) to 100 (optimum foot health)
Measured: At baseline and at the 4- and 12-week follow-ups.
Change in Foot Health Status Questionnaire footwear domain
Ranging from 0 (poor foot health) to 100 (optimum foot health)
Measured: At baseline and at the 4- and 12-week follow-ups.
Change in Foot Health Status Questionnaire general foot health domain
Ranging from 0 (poor foot health) to 100 (optimum foot health)
Measured: At baseline and at the 4- and 12-week follow-ups.
Global Rating of Change
This will be used to measure the participants' self-reported recovery on a 7-point Likert scale ranging from "much improved" to "much worse". Participants are categorised as improved if they rate themselves as "much improved" or "improved" (category 6-7) and categorised as not improved if they rate themselves from "slightly improved" to "much worse" (category 1-5).
Measured: At the 12-week follow-up.
Change in plantar fascia thickness
Measured in millimeters using ultrasonography
Measured: At baseline and at the 4- and 12-week follow-ups.
Time to Patient Acceptable Symptom State
This will be used as a measure of when the participant achieves a self-reported satisfactory result and is therefore not necessarily a measure of complete recovery. After the participant has reported PASS he or she is still instructed to continue performing the exercise as prescribed.
Measured: From 0 to 12 weeks.
Change in Pain Self-Efficacy Questionnaire score
The Pain Self-Efficacy Questionnaire ranges from 0 (not at all confident) to 60 (completely confident) with lower scores indicating lower self-efficacy. A Danish translation of the original questionnaire, which has been validated in a Danish chronic pain population, will be used.
Measured: At baseline and at the 4- and 12-week follow-ups.
Change in physical activity level
This will be measured using the International Physical Activity Questionnaire short form (IPAQ). A Danish translation of the original questionnaire will be used. The IPAQ is the most commonly used questionnaire for measuring physical activity among adults and consists of 9 items that provide information on the time spent performing vigorous and moderate activities, the time spent walking, and time spent sedentary during the past week. The IPAQ gives an estimate of the total weekly physical activity measured in MET-minutes per week and total minutes spent sitting
Measured: At baseline and at the 4- and 12-week follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start12 Oct 2017
- Primary completion17 May 2018
- Study completion17 May 2018
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 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
- NCT03304353
- Sponsor's protocol ID
- N-20170051
- Status last verified
- May 2018
- First submitted
- 4 Oct 2017
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31204294
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Self-managed Resistance Training Protocol Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy During a 12-week Intervention: a Randomised Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT03304353
- Acronym / sponsor ID
- N-20170051
- Conditions
- Plantar Fasciopathy
- Keywords
- Plantar heel pain, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 9 Oct 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.
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.
Detailed description
This trial will be designed as a randomised, participant-blinded, superiority trial, with a 2-group parallel design to be conducted in Denmark. Reporting of the trial will follow CONSORT guidelines for reporting non-pharmacologic treatments and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial was done in accordance with the PREPARE Trial guide (25).
In addition to the exercises, both groups receive patient education on their condition. They will be informed about what is known about the condition in terms of risk factors and aetiology, the pathology, activity modification, and the rationale for why their specific exercise programme (self-managed or predetermined) could lead to recovery. The participants of the predetermined group will be informed that this specific exercise and exercise programme has been found to be superior to stretching but it is important to follow the protocol as closely as possible. The participants of the self-managed group will be informed that this specific exercise has been found to be superior to stretching but based on previous research of other tendinopathies we believe that doing the exercise as heavy as possible but not heavier than 8RM and with as many sets as possible will increase the odds of recovery. Both groups are told that compliance to their protocol is very important and that compliance to the exercises are associated with their recovery. They are also informed about other types of evidence-based treatments however, they are asked to refrain from seeking other treatments during the course of the study. A silicone heel cup will be given to all participants. If the participant already uses an insole or any other type of foot orthosis they will be allowed to continue wearing this if they do not want to use the heel cup.
All statistical analyses will be performed according to a pre-established analysis plan in consultation with a statistician. STATA ver. 14 will be used as statistical software. The primary intention-to-treat analysis will test the between-group difference in the FHSQ pain domain at the 12-week follow-up. In addition to this, between-group comparisons of the other FHSQ domains, PSEQ, IPAQ, and plantar fascia thickness will be performed using a repeated measures ANCOVA with the outcome as the dependent variable, time (baseline, 4 weeks and 12 weeks) as the within-subjects factor, group allocation as the between-subjects factor and the baseline value as the covariate. If any interactions are found, post hoc Bonferroni adjustments for multiple comparisons will be made. The between-group difference in time to PASS among participants who report PASS, and the number of training sessions performed during the trial using independent t-tests. The relative risk (RR) will be calculated for the dichotomized GROC to determine the probability of being improved and for the dichotomized PASS (Yes/No) to determine the probability of achieving a satisfactory result within the 12 weeks of intervention. The difference in mean training sessions performed per week from before to after PASS among participants who report PASS no later than during week 11 of the intervention will be investigated using a paired t-test. The number needed to treat will be calculated as 1/risk difference for the primary outcome. The association between the PSEQ score and compliance will be investigated using Pearson's correlation coefficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-managed protocol | Experimental | Other: Self-managed protocol |
| Predetermined protocol | Active comparator | Other: Predetermined protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
- 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 |
|---|---|---|
| Self-managed protocolParticipants 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. | Other | Self-managed protocol |
| Predetermined protocolParticipants 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. | Other | Predetermined protocol |
Primary outcome
Change in Foot Health Status Questionnaire pain domain
Time frame: At baseline and at the 4- and 12-week follow-ups.
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.
8 secondary outcomes
Change in Foot Health Status Questionnaire function domain
Time frame: At baseline and at the 4- and 12-week follow-ups.
Change in Foot Health Status Questionnaire footwear domain
Time frame: At baseline and at the 4- and 12-week follow-ups.
Change in Foot Health Status Questionnaire general foot health domain
Time frame: At baseline and at the 4- and 12-week follow-ups.
Global Rating of Change
Time frame: At the 12-week follow-up.
Change in plantar fascia thickness
Time frame: At baseline and at the 4- and 12-week follow-ups.
Time to Patient Acceptable Symptom State
Time frame: From 0 to 12 weeks.
Change in Pain Self-Efficacy Questionnaire score
Time frame: At baseline and at the 4- and 12-week follow-ups.
Change in physical activity level
Time frame: At baseline and at the 4- and 12-week follow-ups.
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 23 May 2018.
- Derived from this study: PubMed 31204294Riel 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.
- Individual participant dataSharing planned: Undecided
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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 Self-managed protocol and Predetermined protocol 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 4 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 23 May 2018. 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 Foot Health Status Questionnaire pain domain (time frame: At baseline and at the 4- and 12-week follow-ups.). 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 NCT03304353, 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 23 May 2018.