Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
Overview
- Phase
- Phase 4
- Intervention
- blind injection of Morton neuroma
- Conditions
- Morton Neuroma
- Sponsor
- Complejo Hospitalario Universitario de Granada
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain (VAS score)
- Last Updated
- 8 years ago
Overview
Brief 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
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
Investigators
FERNANDO RUIZ SANTIAGO
PhD, section chief musculoskeletal radiology
Complejo Hospitalario Universitario de Granada
Eligibility Criteria
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
Arms & Interventions
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
Intervention: blind injection of Morton neuroma
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
Intervention: blind injection of Mepivacaine
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
Intervention: blind injection of Triamcinolone
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
Intervention: blind injection of Morton neuroma
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
Intervention: blind injection of Mepivacaine
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
Intervention: blind injection of Triamcinolone
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
Intervention: blind injection of Morton neuroma
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
Intervention: blind injection of Mepivacaine
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
Intervention: blind injection of Triamcinolone
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.
Intervention: ultrasound guided injection
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.
Intervention: guided injection of mepivacaine
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.
Intervention: guided injection of Triamcinolone
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
Intervention: ultrasound guided injection
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
Intervention: guided injection of mepivacaine
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
Intervention: guided injection of Triamcinolone
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
Intervention: ultrasound guided injection
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
Intervention: guided injection of mepivacaine
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
Intervention: guided injection of Triamcinolone
Outcomes
Primary Outcomes
Pain (VAS score)
Time Frame: 1 year
Pain relieve
Secondary Outcomes
- Manchester foot pain and disability index(1 year)
- Generic quality-of-life instrument, the EQ-5D(1 year)