Morton NeuromaNCT03511677
Insole on Morton's Neuroma
A study testing Insole in people with Morton Neuroma, run by Federal University of São Paulo.
Trial summary
Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morton Neuroma
- What is being tested?
- Insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 31 Mar 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
- Patient with clinical and radiological diagnosis (magnetic resonance or ultrasound) of Morton's neuroma.
- Pain in the foot with VAS between 3-8 cm to walk.
- Over 18 years.
- No distinction of sex
- Agree to participate of the study and sign the informed consent form.
Who cannot join
- Other symptomatic musculoskeletal diseases in MMII.
- Symptomatic diseases of the central and peripheral nervous system.
- Diabetes Mellitus.
- Rigid deformities on foot.
- Use of insoles in the last three months.
- Physiotherapy in the last three months.
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- Infiltrations on foot and ankles in the last three months.
- Previous or expected surgery in the next twelve months.
- Allergy to the material of the insole.
- Mental deficiency.
- Geographic inaccessibility .- Use of corticosteroids or NSAIDs in the last month
About this study
Official title: Effectiveness of Insole on Morton's Neuroma
Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use.
Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.
- Conditions
- Morton Neuroma
- Being tested
- Insole, Placebo Insole
- Keywords
- Insole, Morton Neuroma, Pain, Function
- Medical subject headings
- Morton Neuroma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsoleDevice
Customized insole
Placebo InsoleDevice
Placebo flat insole
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Customized insole with metatarsal support Receives: Device: Insole |
| Control Group | Placebo comparator | Placebo flat insole Receives: Device: Placebo Insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Measured by visual analogue scale from 0 cm to 10 cm
Measured: Baseline, after 6, 12 and 24 weeks
Secondary outcomes (4)
Change in function and foot health
Measured by Foot function index questionnaire
Measured: Baseline, after 6, 12 and 24 weeks
Change in function, foot healt and quality of life
Measured by Foot Health Status questionnaire
Measured: Baseline, after 6, 12 and 24 weeks
Change in function
Measured by the distance in the six minute walking test
Measured: Baseline, after 6, 12 and 24 weeks
Quality of life
Measured by the Short Form -36 questionnaire
Measured: Baseline, after 6, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Jun 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morton NeuromaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Hilda Alcantara Veiga de Oliveira, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511677
- Sponsor's protocol ID
- 20634013.9.0000.5505.
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Insole on Morton's Neuroma
- ClinicalTrials.gov ID
- NCT03511677
- Acronym / sponsor ID
- 20634013.9.0000.5505.
- Conditions
- Morton Neuroma
- Keywords
- Insole, Morton Neuroma, Pain, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 30 Apr 2018 (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.
Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use.
Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: InsoleCustomized insole with metatarsal support |
| Control Group | Placebo comparator | Device: Placebo InsolePlacebo flat insole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with clinical and radiological diagnosis (magnetic resonance or ultrasound) of Morton's neuroma.
- Pain in the foot with VAS between 3-8 cm to walk.
- Over 18 years.
- No distinction of sex
- Agree to participate of the study and sign the informed consent form.
Key exclusion criteria (11 listed)
- Other symptomatic musculoskeletal diseases in MMII.
- Symptomatic diseases of the central and peripheral nervous system.
- Diabetes Mellitus.
- Rigid deformities on foot.
- Use of insoles in the last three 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 |
|---|---|---|
| InsoleCustomized insole | Device | Intervention Group |
| Placebo InsolePlacebo flat insole | Device | Control Group |
Primary outcome
Change in pain
Time frame: Baseline, after 6, 12 and 24 weeks
Measured by visual analogue scale from 0 cm to 10 cm
4 secondary outcomes
Change in function and foot health
Time frame: Baseline, after 6, 12 and 24 weeks
Change in function, foot healt and quality of life
Time frame: Baseline, after 6, 12 and 24 weeks
Change in function
Time frame: Baseline, after 6, 12 and 24 weeks
Quality of life
Time frame: Baseline, after 6, 12 and 24 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 30 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Insole in people with Morton Neuroma, run by Federal University of São Paulo.
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 11 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 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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: Baseline, after 6, 12 and 24 weeks). 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 30 Apr 2018.