Morton NeuromaPhase 4NCT03046108
Blind and Ultrasound Guided Injection in Morton Neuroma
A Phase 4 study testing blind injection of Morton neuroma, blind injection of Mepivacaine and blind injection of Triamcinolone in people with Morton Neuroma, run by Complejo Hospitalario Universitario de Granada at 1 site in Spain.
Trial summary
The aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for Morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment 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?
- blind injection of Morton neuroma, blind injection of Mepivacaine and blind injection of Triamcinolone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of Morton neuroma confirmed in ultrasound scan
- Symptoms present more than six months
- The thickness of the nerve must be at least 2 mm in short axis and at least 5 mm in the longitudinal axis.
Who cannot join
- Contraindication for the use of corticosteroids or local anesthetics
- Presence of inflammatory arthropathy or neuropathy
- Skin lesions in the area
- diabetes mellitus
- Infiltration or previous surgery in the area
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario Universitario Granada
Granada, SPA, 18014
JUANA MARIA DE HARO CASTELLANO, +34958 020124, juanam.haro.exts@juntadeandalucia.es
JUAN MORALES ARCAS, +34 958 023136, juan.morales.sspa@juntadeandalucia.es
About this study
Official title: Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
The aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for Morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment
Read the detailed description
This is a evaluator-blinded randomized trial. The final sample size has been calculated to be 100 patients. 50 of group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. 50 of group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance.
The inclusion criteria are clinical suspicion of Morton neuroma confirmed in ultrasound scan. Included patients are assessed clinically by VAS score, the Manchester Foot Pain and Disability Schedule (MFPDS), and a generic quality-of-life instrument, the EQ-5D.
Injection includes 1 cc of 2% mepivacaine and 40 mg of triamcinolone in each web space with Morton Neuroma. According evolution until 4 injections were allowed the first 2 months of follow-up, Follow up was performed by phone calls and/or scheduled consultations at 15 days, 1 month, 45 days, 2 months, 3 months, 6 months and 1 year.
Statistical analysis was performed by unpaired Student's t test
- Conditions
- Morton Neuroma
- Being tested
- blind injection of Morton neuroma, blind injection of Mepivacaine, blind injection of Triamcinolone, ultrasound guided injection, guided injection of mepivacaine
- Medical subject headings
- Morton Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blind injection of Morton neuromaDevice
Also called Blind introduction of the needle
Introduction of a needle based in anatomical landmark
blind injection of MepivacaineDrug
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of TriamcinoloneDrug
Also called Blind introduction of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)
ultrasound guided injectionDevice
Also called guided introduction of the needle
Introduction of a needle based guided by ultrasound
guided injection of mepivacaineDrug
Also called guided perineural injection
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
guided injection of TriamcinoloneDrug
Also called guided perineural injection
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
| Study group | Role | What they receive |
|---|---|---|
| blind injection of Morton neuroma | Active comparator | Percoutaneous blind injection in Morton neuroma by subcutaneous needle group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. There is no internal control of the needle placement.
Mixture of 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up Receives: Device: blind injection of Morton neuroma; Drug: blind injection of Mepivacaine; Drug: blind injection of Triamcinolone |
| blind injection of Mepivacaine | Active comparator | 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up Receives: Device: blind injection of Morton neuroma; Drug: blind injection of Mepivacaine; Drug: blind injection of Triamcinolone |
| blind injection of Triamcinolone | Active comparator | 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up Receives: Device: blind injection of Morton neuroma; Drug: blind injection of Mepivacaine; Drug: blind injection of Triamcinolone |
| ultrasound guided injection | Experimental | US guided injection in Morton neuroma by subcutaneous needle. group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. There is internal control of needle placement by ultrasound. Receives: Device: ultrasound guided injection; Drug: guided injection of mepivacaine; Drug: guided injection of Triamcinolone |
| guided injection of mepivacaine | Experimental | 2% mepivacaine (Mepivacaina Normon 2%® ) in each of the web spaces affected with Morton neuroma is injected.
Up to 4 injections are allow in the first three months of follow-up Receives: Device: ultrasound guided injection; Drug: guided injection of mepivacaine; Drug: guided injection of Triamcinolone |
| guided injection of Triamcinolone | Experimental | 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up Receives: Device: ultrasound guided injection; Drug: guided injection of mepivacaine; Drug: guided injection of Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS score)
Pain relieve
Measured: 1 year
Secondary outcomes (2)
Manchester foot pain and disability index
Disability measurement
Measured: 1 year
Generic quality-of-life instrument, the EQ-5D
Quality of life measurement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startJan 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERNANDO RUIZ SANTIAGO, Complejo Hospitalario Universitario de Granada
- Investigators
- FERNANDO RUIZ SANTIAGO, PhD, Study director, COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046108
- Sponsor's protocol ID
- 0565-N-16
- Status last verified
- Oct 2017
- First submitted
- 20 Nov 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.
Publications
Saygi B, Yildirim Y, Saygi EK, Kara H, Esemenli T. Morton neuroma: comparative results of two conservative methods. Foot Ankle Int. 2005 Jul;26(7):556-9. doi: 10.1177/107110070502600711.
PubMed 16045848Thomson CE, Beggs I, Martin DJ, McMillan D, Edwards RT, Russell D, Yeo ST, Russell IT, Gibson JN. Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial. J Bone Joint Surg Am. 2013 May 1;95(9):790-8, S1. doi: 10.2106/JBJS.I.01780.
PubMed 23636185Mahadevan D, Attwal M, Bhatt R, Bhatia M. Corticosteroid injection for Morton's neuroma with or without ultrasound guidance: a randomised controlled trial. Bone Joint J. 2016 Apr;98-B(4):498-503. doi: 10.1302/0301-620X.98B4.36880.
PubMed 27037432Hassouna H, Singh D, Taylor H, Johnson S. Ultrasound guided steroid injection in the treatment of interdigital neuralgia. Acta Orthop Belg. 2007 Apr;73(2):224-9.
PubMed 17515235
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
- ClinicalTrials.gov ID
- NCT03046108
- Acronym / sponsor ID
- 0565-N-16
- Conditions
- Morton Neuroma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Complejo Hospitalario Universitario de GranadaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 8 Feb 2017 (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.
The aim of this work trial is to compare the effectiveness of blind and ultrasound guided injection for Morton neuroma in order to determine which is more appropriate as the initial procedure in conservative treatment
Detailed description
This is a evaluator-blinded randomized trial. The final sample size has been calculated to be 100 patients. 50 of group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. 50 of group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance.
The inclusion criteria are clinical suspicion of Morton neuroma confirmed in ultrasound scan. Included patients are assessed clinically by VAS score, the Manchester Foot Pain and Disability Schedule (MFPDS), and a generic quality-of-life instrument, the EQ-5D.
Injection includes 1 cc of 2% mepivacaine and 40 mg of triamcinolone in each web space with Morton Neuroma. According evolution until 4 injections were allowed the first 2 months of follow-up, Follow up was performed by phone calls and/or scheduled consultations at 15 days, 1 month, 45 days, 2 months, 3 months, 6 months and 1 year.
Statistical analysis was performed by unpaired Student's t test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| blind injection of Morton neuroma | Active comparator | Device: blind injection of Morton neuroma, Drug: blind injection of Mepivacaine, Drug: blind injection of TriamcinolonePercoutaneous blind injection in Morton neuroma by subcutaneous needle group 1 are going to be injected by an experimented orthopaedic surgeon based on anatomic landmark. There is no internal control of the needle placement. Mixture of 1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up |
| blind injection of Mepivacaine | Active comparator | Device: blind injection of Morton neuroma, Drug: blind injection of Mepivacaine, Drug: blind injection of Triamcinolone1 cc of 2% mepivacaine (Mepivacaina Normon 2%® )+ 40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up |
| blind injection of Triamcinolone | Active comparator | Device: blind injection of Morton neuroma, Drug: blind injection of Mepivacaine, Drug: blind injection of Triamcinolone40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up |
| ultrasound guided injection | Experimental | Device: ultrasound guided injection, Drug: guided injection of mepivacaine, Drug: guided injection of TriamcinoloneUS guided injection in Morton neuroma by subcutaneous needle. group 2 are going to be injected by an experimented musculoskeletal radiologist under ultrasound guidance. There is internal control of needle placement by ultrasound. |
| guided injection of mepivacaine | Experimental | Device: ultrasound guided injection, Drug: guided injection of mepivacaine, Drug: guided injection of Triamcinolone2% mepivacaine (Mepivacaina Normon 2%® ) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up |
| guided injection of Triamcinolone | Experimental | Device: ultrasound guided injection, Drug: guided injection of mepivacaine, Drug: guided injection of Triamcinolone40 mg of triamcinolone (Trigon Depot®) in each of the web spaces affected with Morton neuroma is injected. Up to 4 injections are allow in the first three months of follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical suspicion of Morton neuroma confirmed in ultrasound scan
- Symptoms present more than six months
- The thickness of the nerve must be at least 2 mm in short axis and at least 5 mm in the longitudinal axis.
Key exclusion criteria (6 listed)
- Contraindication for the use of corticosteroids or local anesthetics
- Presence of inflammatory arthropathy or neuropathy
- Skin lesions in the area
- diabetes mellitus
- Infiltration or previous surgery in the area
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 |
|---|---|---|
| blind injection of Morton neuromaAlso: Blind introduction of the needleIntroduction of a needle based in anatomical landmark | Device | blind injection of Mepivacaine, blind injection of Morton neuroma, blind injection of Triamcinolone |
| blind injection of Mepivacaineblind injection of 1 cc of Mepivacaine Normon 2% ® | Drug | blind injection of Mepivacaine, blind injection of Morton neuroma, blind injection of Triamcinolone |
| blind injection of TriamcinoloneAlso: Blind introduction of Triamcinoloneblind injection of 40 mg of triamcinolone (trigon depot ®) | Drug | blind injection of Mepivacaine, blind injection of Morton neuroma, blind injection of Triamcinolone |
| ultrasound guided injectionAlso: guided introduction of the needleIntroduction of a needle based guided by ultrasound | Device | guided injection of Triamcinolone, guided injection of mepivacaine, ultrasound guided injection |
| guided injection of mepivacaineAlso: guided perineural injectionultrasound guided injection of 1 cc of Mepivacaine Normon 2% ® | Drug | guided injection of Triamcinolone, guided injection of mepivacaine, ultrasound guided injection |
| guided injection of TriamcinoloneAlso: guided perineural injectionultrasound guided injection of 40 mg of triamcinolone (trigon depot ®) | Drug | guided injection of Triamcinolone, guided injection of mepivacaine, ultrasound guided injection |
Primary outcome
Pain (VAS score)
Time frame: 1 year
Pain relieve
2 secondary outcomes
Manchester foot pain and disability index
Time frame: 1 year
Generic quality-of-life instrument, the EQ-5D
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Results publication: PubMed 16045848Saygi B, Yildirim Y, Saygi EK, Kara H, Esemenli T. Morton neuroma: comparative results of two conservative methods. Foot Ankle Int. 2005 Jul;26(7):556-9. doi: 10.1177/107110070502600711.
- Results publication: PubMed 23636185Thomson CE, Beggs I, Martin DJ, McMillan D, Edwards RT, Russell D, Yeo ST, Russell IT, Gibson JN. Methylprednisolone injections for the treatment of Morton neuroma: a patient-blinded randomized trial. J Bone Joint Surg Am. 2013 May 1;95(9):790-8, S1. doi: 10.2106/JBJS.I.01780.
- Results publication: PubMed 27037432Mahadevan D, Attwal M, Bhatt R, Bhatia M. Corticosteroid injection for Morton's neuroma with or without ultrasound guidance: a randomised controlled trial. Bone Joint J. 2016 Apr;98-B(4):498-503. doi: 10.1302/0301-620X.98B4.36880.
- Results publication: PubMed 17515235Hassouna H, Singh D, Taylor H, Johnson S. Ultrasound guided steroid injection in the treatment of interdigital neuralgia. Acta Orthop Belg. 2007 Apr;73(2):224-9.
- Individual participant dataSharing planned: Yes. our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.
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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.
FERNANDO RUIZ SANTIAGO, PhD study director
COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing blind injection of Morton neuroma, blind injection of Mepivacaine and blind injection of Triamcinolone in people with Morton Neuroma, run by Complejo Hospitalario Universitario de Granada 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 6 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 18 Oct 2017. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PABLO TOMAS MUÑOZ, PhD (+34617516708, pablotomasm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VAS score) (time frame: 1 year). 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 NCT03046108, which also lists 4 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 18 Oct 2017.