Heel PainPhase 4EPOPLAPAINNCT00888394
Effectiveness of Podiatry on Plantar Pain
A Phase 4 study testing chiropody, basic orthesis and advantage orthesis in people with Heel Pain and Plantar Fasciitis, run by University of Malaga at 2 sites in Spain.
Trial summary
MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the heel pain. SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heel Pain, Plantar Fasciitis, Plantar Pain
- What is being tested?
- chiropody, basic orthesis and advantage orthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2009to Feb 2013
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heel and plantar pain
Who cannot join
- Inflammatory infections and specific organic disease of foot
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Clinica Podologia de la Universidad de malaga
Málaga, Malaga, 29071
Health Science School , University of Malaga
Málaga, Malaga, 29071
About this study
Official title: Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial
MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the heel pain.
SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. To analyze the state of general health and of quality of the patients' life in all the treatment groups. To analyze the study cost-effectiveness of each one of the experimental interventions. DESIGN: randomized controled trial, prospective.
Read more
SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U. Sciences of the Health with footpain like consultation reason.
INTERVENTION: Establishment of four experimental groups with intervention varied podológica. He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24 months, by means of pain scales and function of the foot (FHSQ), the index postural of the foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health (SF-12) and quality of life (Euroqol).
VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry, of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of general health (SF12) and quality of life (Euroqol). Variables of characterization of the sample.
ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the study variables. They will be carried out statistical inferenciales between the main variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon, according to types and normality of variables). Likewise, measures of the size of the effect will settle down in the main variables of result, by means of the relative reduction of the risk, absolute risk and odds ratio, with their respective intervals of trust.
- Conditions
- Heel Pain, Plantar Fasciitis, Plantar Pain
- Being tested
- chiropody, basic orthesis, advantage orthesis, chiropody and advantage orthesis
- Keywords
- chiropody, podiatry, insoles, foot orthesis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiropodyProcedure or surgery
basic procedure of chiropody in podiatry
basic orthesisProcedure or surgery
individual basic orthesis of foot
advantage orthesisProcedure or surgery
advantage orthesis of foot with special material and design
chiropody and advantage orthesisProcedure or surgery
chiropody and advantage orthesis of foot
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: chiropody |
| 2 | Experimental | Not described Receives: Procedure: basic orthesis |
| 3 | Experimental | Not described Receives: Procedure: advantage orthesis |
| 4 | Experimental | Not described Receives: Procedure: chiropody and advantage orthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health state and pain of foot with FHSQ
Measured: total score, pre and post intervention and 6 and 12 months of follow up
Secondary outcomes (2)
quality of life with EuroQoL 5D (Spanish Version)
Measured: scale 0-100, pre and post intervention and follow up 6 and 12 months
biomechanical parameters with Biofoot applications (instrumental systme of dinamic pressure inside shoes)
Measured: Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heel PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888394
- Sponsor's protocol ID
- 173908909-8909-4-9
- Acronym
- EPOPLAPAIN
- Status last verified
- Jan 2013
- First submitted
- 22 Apr 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Quiropodiatry and Orthesis on Heel and Plantar Pain: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00888394
- Acronym / sponsor ID
- EPOPLAPAIN / 173908909-8909-4-9
- Conditions
- Heel Pain, Plantar Fasciitis, Plantar Pain
- Keywords
- chiropody, podiatry, insoles, foot orthesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Apr 2009 (estimated)
- 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.
MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the heel pain.
SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front of each one of the other experimental technologies. To analyze the state of general health and of quality of the patients' life in all the treatment groups. To analyze the study cost-effectiveness of each one of the experimental interventions. DESIGN: randomized controled trial, prospective.
SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U. Sciences of the Health with footpain like consultation reason.
INTERVENTION: Establishment of four experimental groups with intervention varied podológica. He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24 months, by means of pain scales and function of the foot (FHSQ), the index postural of the foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health (SF-12) and quality of life (Euroqol).
VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry, of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of general health (SF12) and quality of life (Euroqol). Variables of characterization of the sample.
ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the study variables. They will be carried out statistical inferenciales between the main variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon, according to types and normality of variables). Likewise, measures of the size of the effect will settle down in the main variables of result, by means of the relative reduction of the risk, absolute risk and odds ratio, with their respective intervals of trust.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: chiropody |
| 2 | Experimental | Procedure: basic orthesis |
| 3 | Experimental | Procedure: advantage orthesis |
| 4 | Experimental | Procedure: chiropody and advantage orthesis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Heel and plantar pain
Key exclusion criteria (1 listed)
- Inflammatory infections and specific organic disease of foot
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 |
|---|---|---|
| chiropodybasic procedure of chiropody in podiatry | Procedure or surgery | 1 |
| basic orthesisindividual basic orthesis of foot | Procedure or surgery | 2 |
| advantage orthesisadvantage orthesis of foot with special material and design | Procedure or surgery | 3 |
| chiropody and advantage orthesischiropody and advantage orthesis of foot | Procedure or surgery | 4 |
Primary outcome
Health state and pain of foot with FHSQ
Time frame: total score, pre and post intervention and 6 and 12 months of follow up
2 secondary outcomes
quality of life with EuroQoL 5D (Spanish Version)
Time frame: scale 0-100, pre and post intervention and follow up 6 and 12 months
biomechanical parameters with Biofoot applications (instrumental systme of dinamic pressure inside shoes)
Time frame: Kp in 68 sensors of plantar foot, changes pre-post intervention and 6 and 12 months of follow up
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 24 Jul 2013.
- University of MalagaLink provided by the sponsor.
- Health Science SchoolLink provided by the sponsor.
- Ethics Comite AndaluciaLink provided by the sponsor.
- R+D SpainLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing chiropody, basic orthesis and advantage orthesis in people with Heel Pain and Plantar Fasciitis, run by University of Malaga at 2 sites 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 1 inclusion and 1 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 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Health state and pain of foot with FHSQ (time frame: total score, pre and post intervention and 6 and 12 months of follow up). 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 24 Jul 2013.