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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| ultrasound guided injection | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blind injection of Morton neuroma | Device | Introduction of a needle based in anatomical landmark |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain (VAS score) | Pain relieve | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Manchester foot pain and disability index | Disability measurement | 1 year |
| Generic quality-of-life instrument, the EQ-5D | Quality of life measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PABLO TOMAS MUÑOZ, PhD | Contact | +34617516708 | pablotomasm@gmail.com | |
| ANA MARIA DEL VALLE DIAZ DE LA GUARDIA, MD | Contact | +34958895414 | anam.valle.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| FERNANDO RUIZ SANTIAGO, PhD | COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario Granada | Recruiting | Granada | SPA | 18014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16045848 | Result | 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. | |
| 23636185 | Result | 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. |
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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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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.
|
| 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 |
|
| 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 |
|
|
| blind injection of Mepivacaine | Drug | blind injection of 1 cc of Mepivacaine Normon 2% ® |
|
| blind injection of Triamcinolone | Drug | blind injection of 40 mg of triamcinolone (trigon depot ®) |
|
|
| ultrasound guided injection | Device | Introduction of a needle based guided by ultrasound |
|
|
| guided injection of mepivacaine | Drug | ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ® |
|
|
| guided injection of Triamcinolone | Drug | ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®) |
|
|
| 1 year |
| 27037432 | Result | 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. |
| 17515235 | Result | 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. |
| ID | Term |
|---|---|
| D000070607 | Morton Neuroma |
| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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