Blind and Ultrasound Guided Injection in Morton Neuroma

Complejo Hospitalario Universitario de Granada

Status and phase: Unknown; Phase 4

Conditions: Morton Neuroma

Treatments: Drug: blind injection of Triamcinolone; Drug: blind injection of Mepivacaine; Device: blind injection of Morton neuroma; Device: ultrasound guided injection; Drug: guided injection of Triamcinolone; Drug: guided injection of mepivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03046108

0565-N-16

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 6 patient groups

blind injection of Morton neuroma

Active Comparator group

Description:

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

Treatment:

Drug: blind injection of Mepivacaine

Device: blind injection of Morton neuroma

Drug: blind injection of Triamcinolone

blind injection of Mepivacaine

Active Comparator group

Description:

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

Treatment:

Drug: blind injection of Mepivacaine

Device: blind injection of Morton neuroma

Drug: blind injection of Triamcinolone

blind injection of Triamcinolone

Active Comparator group

Description:

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

Treatment:

Drug: blind injection of Mepivacaine

Device: blind injection of Morton neuroma

Drug: blind injection of Triamcinolone

ultrasound guided injection

Experimental group

Description:

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.

Treatment:

Drug: guided injection of mepivacaine

Drug: guided injection of Triamcinolone

Device: ultrasound guided injection

guided injection of mepivacaine

Experimental group

Description:

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

Treatment:

Drug: guided injection of mepivacaine

Drug: guided injection of Triamcinolone

Device: ultrasound guided injection

guided injection of Triamcinolone

Experimental group

Description:

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

Treatment:

Drug: guided injection of mepivacaine

Drug: guided injection of Triamcinolone

Device: ultrasound guided injection