Blind and Ultrasound Guided Injection in Morton Neuroma
Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 20, 2016
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 18, 2017
October 1, 2017
2.6 years
November 20, 2016
October 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pain (VAS score)
Pain relieve
1 year
Secondary Outcomes (2)
Manchester foot pain and disability index
1 year
Generic quality-of-life instrument, the EQ-5D
1 year
Study Arms (6)
blind injection of Morton neuroma
ACTIVE COMPARATORPercoutaneous 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
blind injection of Mepivacaine
ACTIVE COMPARATOR1 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
blind injection of Triamcinolone
ACTIVE COMPARATOR40 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
ultrasound guided injection
EXPERIMENTALUS 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.
guided injection of mepivacaine
EXPERIMENTAL2% 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
guided injection of Triamcinolone
EXPERIMENTAL40 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
Interventions
Introduction of a needle based in anatomical landmark
blind injection of 1 cc of Mepivacaine Normon 2% ®
blind injection of 40 mg of triamcinolone (trigon depot ®)
Introduction of a needle based guided by ultrasound
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Complejo Hospitalario Universitario Granada
Granada, SPA, 18014, Spain
Related Publications (4)
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.
PMID: 16045848RESULTThomson 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.
PMID: 23636185RESULTMahadevan 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.
PMID: 27037432RESULTHassouna 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.
PMID: 17515235RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
FERNANDO RUIZ SANTIAGO, PhD
COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, section chief musculoskeletal radiology
Study Record Dates
First Submitted
November 20, 2016
First Posted
February 8, 2017
Study Start
January 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
October 18, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
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.