Blind and Ultrasound Guided Injection in Morton Neuroma
NCT ID: NCT03046108
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2016-01-31
2018-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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blind injection of Morton neuroma
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
blind injection of Morton neuroma
Introduction of a needle based in anatomical landmark
blind injection of Mepivacaine
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)
blind injection of Mepivacaine
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 Morton neuroma
Introduction of a needle based in anatomical landmark
blind injection of Mepivacaine
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)
blind injection of Triamcinolone
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 Morton neuroma
Introduction of a needle based in anatomical landmark
blind injection of Mepivacaine
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)
ultrasound guided injection
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.
ultrasound guided injection
Introduction of a needle based guided by ultrasound
guided injection of mepivacaine
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
guided injection of Triamcinolone
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
guided injection of mepivacaine
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
ultrasound guided injection
Introduction of a needle based guided by ultrasound
guided injection of mepivacaine
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
guided injection of Triamcinolone
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
guided injection of Triamcinolone
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
ultrasound guided injection
Introduction of a needle based guided by ultrasound
guided injection of mepivacaine
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
guided injection of Triamcinolone
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
Interventions
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blind injection of Morton neuroma
Introduction of a needle based in anatomical landmark
blind injection of Mepivacaine
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)
ultrasound guided injection
Introduction of a needle based guided by ultrasound
guided injection of mepivacaine
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
guided injection of Triamcinolone
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Complejo Hospitalario Universitario de Granada
OTHER
Responsible Party
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FERNANDO RUIZ SANTIAGO
PhD, section chief musculoskeletal radiology
Principal Investigators
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FERNANDO RUIZ SANTIAGO, PhD
Role: STUDY_DIRECTOR
COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA
Locations
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Complejo Hospitalario Universitario Granada
Granada, SPA, Spain
Countries
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Central Contacts
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ANA MARIA DEL VALLE DIAZ DE LA GUARDIA, MD
Role: CONTACT
Phone: +34958895414
Email: [email protected]
Facility Contacts
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JUANA MARIA DE HARO CASTELLANO
Role: primary
JUAN MORALES ARCAS
Role: backup
References
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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.
Thomson 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.
Mahadevan 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.
Hassouna 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.
Other Identifiers
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0565-N-16
Identifier Type: -
Identifier Source: org_study_id