Blind and Ultrasound Guided Injection in Morton Neuroma

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma

Conditions
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Morton Neuroma

Intervention / Treatment
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* Device: blind injection of Morton neuroma
* Drug: blind injection of Mepivacaine
* Drug: blind injection of Triamcinolone
* Device: ultrasound guided injection
* Drug: guided injection of mepivacaine
* Drug: guided injection of Triamcinolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: blind injection of Morton neuroma<br>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 | Device: blind injection of Morton neuroma<br>* Introduction of a needle based in anatomical landmark<br>* Other names: Blind introduction of the needle;Drug: blind injection of Mepivacaine<br>* blind injection of 1 cc of Mepivacaine Normon 2% ®<br>Drug: blind injection of Triamcinolone<br>* blind injection of 40 mg of triamcinolone (trigon depot ®)<br>* Other names: Blind introduction of Triamcinolone;|
| Active Comparator: blind injection of Mepivacaine<br>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 | Device: blind injection of Morton neuroma<br>* Introduction of a needle based in anatomical landmark<br>* Other names: Blind introduction of the needle;Drug: blind injection of Mepivacaine<br>* blind injection of 1 cc of Mepivacaine Normon 2% ®<br>Drug: blind injection of Triamcinolone<br>* blind injection of 40 mg of triamcinolone (trigon depot ®)<br>* Other names: Blind introduction of Triamcinolone;|
| Active Comparator: blind injection of Triamcinolone<br>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 | Device: blind injection of Morton neuroma<br>* Introduction of a needle based in anatomical landmark<br>* Other names: Blind introduction of the needle;Drug: blind injection of Mepivacaine<br>* blind injection of 1 cc of Mepivacaine Normon 2% ®<br>Drug: blind injection of Triamcinolone<br>* blind injection of 40 mg of triamcinolone (trigon depot ®)<br>* Other names: Blind introduction of Triamcinolone;|
| Experimental: ultrasound guided injection<br>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. | Device: ultrasound guided injection<br>* Introduction of a needle based guided by ultrasound<br>* Other names: guided introduction of the needle;Drug: guided injection of mepivacaine<br>* ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®<br>* Other names: guided perineural injection;Drug: guided injection of Triamcinolone<br>* ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)<br>* Other names: guided perineural injection;|
| Experimental: guided injection of mepivacaine<br>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 | Device: ultrasound guided injection<br>* Introduction of a needle based guided by ultrasound<br>* Other names: guided introduction of the needle;Drug: guided injection of mepivacaine<br>* ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®<br>* Other names: guided perineural injection;Drug: guided injection of Triamcinolone<br>* ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)<br>* Other names: guided perineural injection;|
| Experimental: guided injection of Triamcinolone<br>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 | Device: ultrasound guided injection<br>* Introduction of a needle based guided by ultrasound<br>* Other names: guided introduction of the needle;Drug: guided injection of mepivacaine<br>* ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®<br>* Other names: guided perineural injection;Drug: guided injection of Triamcinolone<br>* ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)<br>* Other names: guided perineural injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (VAS score) | Pain relieve | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 year |