Clinical trial NCT03046108: Blind and Ultrasound Guided Injection in Morton Neuroma
Official title: Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Morton Neuroma
Lead sponsor: Complejo Hospitalario Universitario de Granada
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Pain (VAS score)
timeFrame: 1 year
Secondary outcomes:
measure: Manchester foot pain and disability index
timeFrame: 1 year
measure: Generic quality-of-life instrument, the EQ-5D
timeFrame: 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario Granada
state: SPA
Study officials:
affiliation: COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA
name: FERNANDO RUIZ SANTIAGO, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.