Blind and Ultrasound Guided Injection in Morton Neuroma

Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma

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

Study Overview

• Status: Unknown
• Conditions: Morton Neuroma
• Intervention / Treatment: 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

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: PABLO TOMAS MUÑOZ, PhD; Phone Number: +34617516708; Email: pablotomasm@gmail.com
• Study Contact Backup: Name: Ana María Del Valle Díaz De La Guardia, MD; Phone Number: +34958895414; Email: anam.valle.sspa@juntadeandalucia.es

Study Locations

• Spain
  • SPA
    • Granada, SPA, Spain, 18014
      • Recruiting
      • Complejo Hospitalario Universitario Granada
      • Contact: JUANA MARIA DE HARO CASTELLANO; Phone Number: +34958 020124; Email: juanam.haro.exts@juntadeandalucia.es
      • Contact: JUAN MORALES ARCAS; Phone Number: +34 958 023136; Email: juan.morales.sspa@juntadeandalucia.es
      • Sub-Investigator: NICOLAS PRADOS OLLETA, PhD
      • Sub-Investigator: PABLO TOMAS MUÑOZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Complejo Hospitalario Universitario de Granada
• Investigators: Study Director: FERNANDO RUIZ SANTIAGO, PhD, Complejo Hospitalario Universitario Granada

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: November 20, 2016
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Neuralgia; Nerve Sheath Neoplasms; Metatarsalgia; Neuroma; Morton Neuroma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Mepivacaine
• Other Study ID Numbers: 0565-N-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: our idea is to publish the short term results and the long term results in order to influence management of this pathology. Tables and statistical analysis will be available for review and metaanalysis.