Plantar FasciopathyFIX-HeelNCT03804008
Advice vs Advice + Exercise vs Advice + Exercise + Injection for Individuals With Plantar Fasciopathy
A study testing Ultrasound-guided corticosteroid injection, Heavy-slow resistance training and Fundamental advice and a silicone heel cup in people with Plantar Fasciopathy, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this trial is to investigate the efficacy of fundamental patient advice and a heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an ultrasound-guided corticosteroid… 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?
- Ultrasound-guided corticosteroid injection, Heavy-slow resistance training and Fundamental advice and a silicone heel cup
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Feb 2019to 23 Sep 2021
- 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 as measured by ultrasonography
- mean heel pain of ≥30 mm on a 100 mm VAS during the previous week
Who cannot join
- below 18 years of age
- diabetes
- history of inflammatory systemic diseases
- pregnancy or breastfeeding
- corticosteroid injection for plantar fasciopathy within the previous six months
- pain or stiffness in the 1st metatarsophalangeal joint to an extent where the exercises cannot be performed
Show all 10Show fewer
- known hypersensitivity to corticosteroids or local anaesthetics
- skin or soft tissue infection near the injection site
- received treatment by a healthcare professional for plantar fasciopathy within the previous 12 weeks
- made any substantial changes to usual self-care of the condition in the last 4 weeks (e.g. started using insoles, started performing stretching, made a substantial decrease in physical activity level)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of occupational therapy and physiotherapy, Aalborg University Hospital
Hobrovej 18-22, 9000
About this study
Official title: The Efficacy of Fundamental Advice and a Heel Cup Versus Fundamental Advice and a Heel Cup Plus eXercise Versus Fundamental Advice and a Heel Cup Plus Exercise and a Corticosteroid Injection in Individuals With Plantar Fasciopathy
The purpose of this trial is to investigate the efficacy of fundamental patient advice and a heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy after 12 weeks.
Read the detailed description
This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a 3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial is done in accordance with the PREPARE Trial guide.
Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1) into 3 parallel groups of 60 participants using a random number generator on www.sealedenvelope.com. The block sizes will be random and concealed to the research assistants responsible of including participants. Group allocation will be coded, and the data analyst will be blinded to this code until after the analyses have been performed.
The investigators will only conclude superiority of one intervention over the other if the intention-to-treat analysis leads to mean between-group differences of the Foot Health Status Questionnaire pain domain ≥14 points (minimally important difference) and P-values <0.05 at the primary endpoint (12 weeks) after adjustment for the baseline value.
- Conditions
- Plantar Fasciopathy
- Being tested
- Ultrasound-guided corticosteroid injection, Heavy-slow resistance training, Fundamental advice and a silicone heel cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided corticosteroid injectionDrug
A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid 20mg/ml + 1 ml Lidocain 10 mg7ml. The skin is cleansed with Chlorhexidine alcohol 0.5 %. 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. Participants are asked to start performing the exercise as soon as they feel ready but not before 24 hours after the injection. Furthermore, they are asked not to progress the method used to achieve 8RM when they start to do the exercise after the injection until Week 3 of the exercise programme. If standing on both feet was sufficient to achieve 8RM at baseline, the participant must not perform the exercise single-legged or to wear a backpack with weights after the injection regardless of any pain reduction afforded by the injection.
Heavy-slow resistance trainingOther
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. Participants 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.
Fundamental advice and a silicone heel cupOther
Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.
| Study group | Role | What they receive |
|---|---|---|
| Fundamental advice and a heel cup | Active comparator | Not described Receives: Other: Fundamental advice and a silicone heel cup |
| Fundamental advice and a heel cup plus exercise | Active comparator | Not described Receives: Other: Heavy-slow resistance training; Other: Fundamental advice and a silicone heel cup |
| Fundamental advice and a heel cup plus exercise and injection | Active comparator | Not described Receives: Drug: Ultrasound-guided corticosteroid injection; Other: Heavy-slow resistance training; Other: Fundamental advice and a silicone heel cup |
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 validated Danish translation of the original questionnaire will be used.
Measured: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Secondary outcomes (8)
Change in Foot Health Status Questionnaire function domain
Ranging from 0 (poor foot health) to 100 (optimum foot health)
Measured: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Change in Foot Health Status Questionnaire footwear domain
Ranging from 0 (poor foot health) to 100 (optimum foot health)
Measured: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Change in Foot Health Status Questionnaire general foot health domain
Ranging from 0 (poor foot health) to 100 (optimum foot health)
Measured: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
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 follow-ups after 12, 26 and 52 weeks
Time to Patient Acceptable Symptom State
This will be used as a measure of when participants achieve a self-evaluated satisfactory result and feels no further treatment is needed; hence, it is not necessarily a measure of complete recovery
Measured: From 0 to 52 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: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents
Participants will be wearing a wrist-worn accelerometer ((ActiGraph wGT3X-BT (ActiGraph LLC, Pensacola, FL, USA)) during the first three weeks after baseline and again during the first three weeks after the 12-week follow-up.
Measured: Week 1 and Week 13 of the interventions
Change in self-reported health state as measured by the EQ-5D-5L
Measured: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start7 Feb 2019
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Riel, Aalborg University
- Investigators
- Michael S Rathleff, PhD, Study chair, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804008
- Sponsor's protocol ID
- N-20180066
- Acronym
- FIX-Heel
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Riel H, Vicenzino B, Olesen JL, Bach Jensen M, Ehlers LH, Rathleff MS. Does a corticosteroid injection plus exercise or exercise alone add to the effect of patient advice and a heel cup for patients with plantar fasciopathy? A randomised clinical trial. Br J Sports Med. 2023 Sep;57(18):1180-1186. doi: 10.1136/bjsports-2023-106948. Epub 2023 Jul 6.
PubMed 37414460Riel H, Vicenzino B, Olesen JL, Jensen MB, Ehlers LH, Rathleff MS. Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial). Trials. 2020 Jan 2;21(1):5. doi: 10.1186/s13063-019-3977-0.
PubMed 31898517
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Fundamental Advice and a Heel Cup Versus Fundamental Advice and a Heel Cup Plus eXercise Versus Fundamental Advice and a Heel Cup Plus Exercise and a Corticosteroid Injection in Individuals With Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT03804008
- Acronym / sponsor ID
- FIX-Heel / N-20180066
- Conditions
- Plantar Fasciopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 15 Jan 2019 (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 the efficacy of fundamental patient advice and a heel cup versus fundamental patient advice and a heel cup plus heavy-slow resistance training versus fundamental patient advice and a heel cup plus heavy-slow resistance training and an ultrasound-guided corticosteroid injection in improving the Foot Health Status Questionnaire pain domain score in individuals with plantar fasciopathy after 12 weeks.
Detailed description
This trial will be designed as a randomised, data analyst-blinded, superiority trial, with a 3-group parallel design to be conducted in Aalborg, Denmark. Reporting of the trial will follow CONSORT guidelines and TIDieR for intervention description. Reporting of the protocol will follow the SPIRIT statement. The planning of the trial is done in accordance with the PREPARE Trial guide.
Participants will be stratified by sex and block randomised in block sizes of 3 to 12 (1:1:1) into 3 parallel groups of 60 participants using a random number generator on www.sealedenvelope.com. The block sizes will be random and concealed to the research assistants responsible of including participants. Group allocation will be coded, and the data analyst will be blinded to this code until after the analyses have been performed.
The investigators will only conclude superiority of one intervention over the other if the intention-to-treat analysis leads to mean between-group differences of the Foot Health Status Questionnaire pain domain ≥14 points (minimally important difference) and P-values <0.05 at the primary endpoint (12 weeks) after adjustment for the baseline value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fundamental advice and a heel cup | Active comparator | Other: Fundamental advice and a silicone heel cup |
| Fundamental advice and a heel cup plus exercise | Active comparator | Other: Heavy-slow resistance training, Other: Fundamental advice and a silicone heel cup |
| Fundamental advice and a heel cup plus exercise and injection | Active comparator | Drug: Ultrasound-guided corticosteroid injection, Other: Heavy-slow resistance training, Other: Fundamental advice and a silicone heel cup |
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 as measured by ultrasonography
- mean heel pain of ≥30 mm on a 100 mm VAS during the previous week
Key exclusion criteria (10 listed)
- below 18 years of age
- diabetes
- history of inflammatory systemic diseases
- pregnancy or breastfeeding
- corticosteroid injection for plantar fasciopathy within the previous six months
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 |
|---|---|---|
| Ultrasound-guided corticosteroid injectionA 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid 20mg/ml + 1 ml Lidocain 10 mg7ml. The skin is cleansed with Chlorhexidine alcohol 0.5 %. 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. Participants are asked to start performing the exercise as soon as they feel ready but not before 24 hours after the injection. Furthermore, they are asked not to progress the method used to achieve 8RM when they start to do the exercise after the injection until Week 3 of the exercise programme. If standing on both feet was sufficient to achieve 8RM at baseline, the participant must not perform the exercise single-legged or to wear a backpack with weights after the injection regardless of any pain reduction afforded by the injection. | Drug | Fundamental advice and a heel cup plus exercise and injection |
| Heavy-slow resistance trainingParticipants 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. Participants 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 | Fundamental advice and a heel cup plus exercise, Fundamental advice and a heel cup plus exercise and injection |
| Fundamental advice and a silicone heel cupParticipants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup. | Other | Fundamental advice and a heel cup, Fundamental advice and a heel cup plus exercise, Fundamental advice and a heel cup plus exercise and injection |
Primary outcome
Change in Foot Health Status Questionnaire pain domain
Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
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 validated Danish translation of the original questionnaire will be used.
8 secondary outcomes
Change in Foot Health Status Questionnaire function domain
Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Change in Foot Health Status Questionnaire footwear domain
Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Change in Foot Health Status Questionnaire general foot health domain
Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Global Rating of Change
Time frame: At follow-ups after 12, 26 and 52 weeks
Time to Patient Acceptable Symptom State
Time frame: From 0 to 52 weeks
Change in Pain Self-Efficacy Questionnaire score
Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
Change in weekly light, moderate and vigorous physical activity level expressed as Metabolic Equivalents
Time frame: Week 1 and Week 13 of the interventions
Change in self-reported health state as measured by the EQ-5D-5L
Time frame: During baseline and at follow-ups after 4, 12, 26 and 52 weeks
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 11 Jan 2022.
- Derived from this study: PubMed 37414460Riel H, Vicenzino B, Olesen JL, Bach Jensen M, Ehlers LH, Rathleff MS. Does a corticosteroid injection plus exercise or exercise alone add to the effect of patient advice and a heel cup for patients with plantar fasciopathy? A randomised clinical trial. Br J Sports Med. 2023 Sep;57(18):1180-1186. doi: 10.1136/bjsports-2023-106948. Epub 2023 Jul 6.
- Derived from this study: PubMed 31898517Riel H, Vicenzino B, Olesen JL, Jensen MB, Ehlers LH, Rathleff MS. Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial). Trials. 2020 Jan 2;21(1):5. doi: 10.1186/s13063-019-3977-0.
- 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.
Michael S Rathleff, PhD study chair
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 Ultrasound-guided corticosteroid injection, Heavy-slow resistance training and Fundamental advice and a silicone heel cup 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 10 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 11 Jan 2022. 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: During baseline and at follow-ups after 4, 12, 26 and 52 weeks). 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 NCT03804008, which also lists 2 linked publications.
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 11 Jan 2022.