Calcaneal ApophysitisNCT03960086
Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
A study testing Podoactiva cutom-made foot orthoses and Podoactiva heel lifts in people with Calcaneal Apophysitis and Sever's Disease, run by Fundacion Podoactiva at 1 site in Spain.
Trial summary
The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Calcaneal Apophysitis, Sever's Disease
- What is being tested?
- Podoactiva cutom-made foot orthoses and Podoactiva heel lifts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2019to 14 Feb 2020
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed radiologically with calcaneal osteochondritis
- diagnosed radiologically with calcaneal osteochondritis
- have signed informed consent
Who cannot join
- had suffered some trauma on the heel in the past 2 months
- had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
- had presented physical or neurological impairment
- were not interested
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.
It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.
- Conditions
- Calcaneal Apophysitis, Sever's Disease
- Being tested
- Podoactiva cutom-made foot orthoses, Podoactiva heel lifts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podoactiva cutom-made foot orthosesOther
Children had to use the orthotics daily during the intervention period
Podoactiva heel liftsOther
Children had to use the orthotics daily during the intervention period
| Study group | Role | What they receive |
|---|---|---|
| Custom-made foot orthoses | Experimental | Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.
Treatment period of 12 weeks Receives: Other: Podoactiva cutom-made foot orthoses |
| Heel Lifts | Active comparator | Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.
Treatment period of 12 weeks Receives: Other: Podoactiva heel lifts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogical scale (VAS)
Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS)
Measured: At baseine and after the intervention period
Algometry
Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention
Measured: At baseine and after the intervention period
Sport activity pain perception
Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention
Measured: At baseine and after the intervention period
Secondary outcomes (2)
Foot Posture Index (FPI)
values of Foot Posture Index (FPI) test in children with calcaneal apophysistis
Measured: At baseline
lunge test values
values of lunge test in children with calcaneal apophysistis
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start12 Jun 2019
- Primary completion10 Dec 2019
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcaneal ApophysitisStudies 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
- Model description
- The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Podoactiva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960086
- Sponsor's protocol ID
- Sever insoles-heel lifts
- Status last verified
- Oct 2020
- First submitted
- 15 May 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, participants in this study were not adults and in the informed consent signed there was not indiated this statment
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03960086
- Acronym / sponsor ID
- Sever insoles-heel lifts
- Conditions
- Calcaneal Apophysitis, Sever's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Fundacion PodoactivaUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 22 May 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 study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.
It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
| Arm | Type | Receives |
|---|---|---|
| Custom-made foot orthoses | Experimental | Other: Podoactiva cutom-made foot orthosesChildren in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity. Treatment period of 12 weeks |
| Heel Lifts | Active comparator | Other: Podoactiva heel liftsChildren in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity. Treatment period of 12 weeks |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosed radiologically with calcaneal osteochondritis
- diagnosed radiologically with calcaneal osteochondritis
- have signed informed consent
Key exclusion criteria (4 listed)
- had suffered some trauma on the heel in the past 2 months
- had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
- had presented physical or neurological impairment
- were not interested
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 |
|---|---|---|
| Podoactiva cutom-made foot orthosesChildren had to use the orthotics daily during the intervention period | Other | Custom-made foot orthoses |
| Podoactiva heel liftsChildren had to use the orthotics daily during the intervention period | Other | Heel Lifts |
Primary outcome
Visual analogical scale (VAS)
Time frame: At baseine and after the intervention period
Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS)
Algometry
Time frame: At baseine and after the intervention period
Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention
Sport activity pain perception
Time frame: At baseine and after the intervention period
Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention
2 secondary outcomes
Foot Posture Index (FPI)
Time frame: At baseline
lunge test values
Time frame: At baseline
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 19 Oct 2020.
- Individual participant dataSharing planned: No. No, participants in this study were not adults and in the informed consent signed there was not indiated this statment
Related trials for Calcaneal Apophysitis
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Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
Recruiting
Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes
Osgood-Schlatter Disease, Sever's Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Podoactiva cutom-made foot orthoses and Podoactiva heel lifts in people with Calcaneal Apophysitis and Sever's Disease, run by Fundacion Podoactiva at 1 site in Spain.
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 3 inclusion and 4 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 19 Oct 2020. 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 Spain. 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?
Visual analogical scale (VAS) (time frame: At baseine and after the intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2020.