Morton NeuromaREQUIEMNCT05550831
Radiofrequency Before to Surgical Removal of a Recalcitrant Morton´s Neuroma
A study testing Radiofrequency in people with Morton Neuroma and Radriofrequency, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
The purpose of this study is to perform a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morton Neuroma, Radriofrequency
- What is being tested?
- Radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2022to 15 May 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged between 18 and 70 years
- Patient with neuroma of morton of more than 1 year of evolution
- Patient treated by conservative treatments, stencils, various infiltrations, stretching and with symptomatology that limits his daily activities.
- Healthy patients without previous systemic pathologies (diabetes, coagulation or immunological disorders), ASA I or II that require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
- freely accept and sign the informed consent for participation in the study.
Who cannot join
- Allergy to local anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to perform a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact.
- Conditions
- Morton Neuroma, Radriofrequency
- Being tested
- Radiofrequency
- Keywords
- Foot, Morton Neuroma, Radiofrequency
- Medical subject headings
- Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofrequencyProcedure or surgery
Peripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by an electrode.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Radiofrequency procedure prior to the removal of morton's neuroma.
* Radiofrequency Machine: Multilesion Generator 3 Channels TLG-10 STP.
* Temperature: 80-85ºC
* Time: 90 seconds
* Active needle size: 1 cm
* Number of Applications: 3
* Impedance: less than 550
* Ultrasound. General Electric Logic R7 with 12 Mgh probe. Receives: Procedure: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve Damage
Anatomopathology of the nerve
Measured: 1 week
Quality of Life, FFI
FFI Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Oct 2022
- Primary completion15 Nov 2022
- Study completion15 May 2023 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Model description
- Performing a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact. * Step 1: Visualize the needle on the long axis of the probe. * Step 2: Neurostimulate * Step 3: Deposit of 1-2cc of anesthetic and wait about 2 minutes. * Step 4: we apply the continuous radiofrequency at that point and once done we change the position of the needle to more dorsal planes anatomically and we made 2 more applications (in this case we will no longer have neurostimulation because the patient will be anesthetized).
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Martínez Nova, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550831
- Sponsor's protocol ID
- REQUIEM
- Acronym
- REQUIEM
- Status last verified
- May 2023
- First submitted
- 19 Sep 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Before to Surgical Removal of a Recalcitrant Morton´s Neuroma
- ClinicalTrials.gov ID
- NCT05550831
- Acronym / sponsor ID
- REQUIEM / REQUIEM
- Conditions
- Morton Neuroma, Radriofrequency
- Keywords
- Foot, Morton Neuroma, Radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 22 Sep 2022 (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 study is to perform a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Performing a radiofrequency procedure prior to the removal of morton's neuroma. This procedure would be performed to check in which percentage of the nerve ablation has been performed, and whether the current protocol is performed correctly or parts of the nerve remain intact. * Step 1: Visualize the needle on the long axis of the probe. * Step 2: Neurostimulate * Step 3: Deposit of 1-2cc of anesthetic and wait about 2 minutes. * Step 4: we apply the continuous radiofrequency at that point and once done we change the position of the needle to more dorsal planes anatomically and we made 2 more applications (in this case we will no longer have neurostimulation because the patient will be anesthetized).
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Procedure: RadiofrequencyRadiofrequency procedure prior to the removal of morton's neuroma. * Radiofrequency Machine: Multilesion Generator 3 Channels TLG-10 STP. * Temperature: 80-85ºC * Time: 90 seconds * Active needle size: 1 cm * Number of Applications: 3 * Impedance: less than 550 * Ultrasound. General Electric Logic R7 with 12 Mgh probe. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged between 18 and 70 years
- Patient with neuroma of morton of more than 1 year of evolution
- Patient treated by conservative treatments, stencils, various infiltrations, stretching and with symptomatology that limits his daily activities.
- Healthy patients without previous systemic pathologies (diabetes, coagulation or immunological disorders), ASA I or II that require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
- freely accept and sign the informed consent for participation in the study.
Key exclusion criteria (1 listed)
- Allergy to local anesthesia.
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 |
|---|---|---|
| RadiofrequencyPeripheral ablation of affected Morton´s Neuroma nerve endings by thermal dissipation by an electrode. | Procedure or surgery | Radiofrequency |
Primary outcome
Nerve Damage
Time frame: 1 week
Anatomopathology of the nerve
Quality of Life, FFI
Time frame: 6 months
FFI Questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- 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.
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 Radiofrequency in people with Morton Neuroma and Radriofrequency, run by Universidad de Extremadura 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 5 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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?
Results are not available in the source record.
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?
Nerve Damage (time frame: 1 week). The study lists 2 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 10 May 2023.