Blind and Ultrasound Guided Injection in Morton Neuroma

Morton Neuroma Clinical Trial

Official title:

Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03046108
• Other study ID #: 0565-N-16
• Status: Recruiting
• Phase: Phase 4
• First received: November 20, 2016
• Last updated: October 17, 2017
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2017
• Source: Complejo Hospitalario Universitario de Granada
• Contact: PABLO TOMAS MUÑOZ, PhD
• Phone: +34617516708
• Email: pablotomasm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Morton Neuroma
• Neuroma

Intervention

Device:
• blind injection of Morton neuroma
Introduction of a needle based in anatomical landmark

Drug:
• blind injection of Mepivacaine
blind injection of 1 cc of Mepivacaine Normon 2% ®
• blind injection of Triamcinolone
blind injection of 40 mg of triamcinolone (trigon depot ®)

Device:
• ultrasound guided injection
Introduction of a needle based guided by ultrasound

Drug:
• guided injection of mepivacaine
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
• guided injection of Triamcinolone
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario Granada	Granada	SPA

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario Universitario de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VAS score)	Pain relieve	1 year
Secondary	Manchester foot pain and disability index	Disability measurement	1 year
Secondary	Generic quality-of-life instrument, the EQ-5D	Quality of life measurement	1 year