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Blind and Ultrasound Guided Injection in Morton Neuroma

Primary Purpose

Morton Neuroma

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
blind injection of Morton neuroma
blind injection of Mepivacaine
blind injection of Triamcinolone
ultrasound guided injection
guided injection of mepivacaine
guided injection of Triamcinolone
Sponsored by
Complejo Hospitalario Universitario de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morton Neuroma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Complejo Hospitalario Universitario GranadaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

blind injection of Morton neuroma

blind injection of Mepivacaine

blind injection of Triamcinolone

ultrasound guided injection

guided injection of mepivacaine

guided injection of Triamcinolone

Arm Description

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

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

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

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.

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

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

Outcomes

Primary Outcome Measures

Pain (VAS score)
Pain relieve

Secondary Outcome Measures

Manchester foot pain and disability index
Disability measurement
Generic quality-of-life instrument, the EQ-5D
Quality of life measurement

Full Information

First Posted
November 20, 2016
Last Updated
October 17, 2017
Sponsor
Complejo Hospitalario Universitario de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03046108
Brief Title
Blind and Ultrasound Guided Injection in Morton Neuroma
Official Title
Comparison Between Blind and Ultrasound Guided Injection in Morton Neuroma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complejo Hospitalario Universitario de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morton Neuroma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
blind injection of Morton neuroma
Arm Type
Active Comparator
Arm Description
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
Arm Title
blind injection of Mepivacaine
Arm Type
Active Comparator
Arm Description
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
Arm Title
blind injection of Triamcinolone
Arm Type
Active Comparator
Arm Description
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
Arm Title
ultrasound guided injection
Arm Type
Experimental
Arm Description
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.
Arm Title
guided injection of mepivacaine
Arm Type
Experimental
Arm Description
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
Arm Title
guided injection of Triamcinolone
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
blind injection of Morton neuroma
Other Intervention Name(s)
Blind introduction of the needle
Intervention Description
Introduction of a needle based in anatomical landmark
Intervention Type
Drug
Intervention Name(s)
blind injection of Mepivacaine
Intervention Description
blind injection of 1 cc of Mepivacaine Normon 2% ®
Intervention Type
Drug
Intervention Name(s)
blind injection of Triamcinolone
Other Intervention Name(s)
Blind introduction of Triamcinolone
Intervention Description
blind injection of 40 mg of triamcinolone (trigon depot ®)
Intervention Type
Device
Intervention Name(s)
ultrasound guided injection
Other Intervention Name(s)
guided introduction of the needle
Intervention Description
Introduction of a needle based guided by ultrasound
Intervention Type
Drug
Intervention Name(s)
guided injection of mepivacaine
Other Intervention Name(s)
guided perineural injection
Intervention Description
ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
Intervention Type
Drug
Intervention Name(s)
guided injection of Triamcinolone
Other Intervention Name(s)
guided perineural injection
Intervention Description
ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
Primary Outcome Measure Information:
Title
Pain (VAS score)
Description
Pain relieve
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Manchester foot pain and disability index
Description
Disability measurement
Time Frame
1 year
Title
Generic quality-of-life instrument, the EQ-5D
Description
Quality of life measurement
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PABLO TOMAS MUÑOZ, PhD
Phone
+34617516708
Email
pablotomasm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ANA MARIA DEL VALLE DIAZ DE LA GUARDIA, MD
Phone
+34958895414
Email
anam.valle.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FERNANDO RUIZ SANTIAGO, PhD
Organizational Affiliation
COMPLEJO HOSPITALARIO UNIVERSITARIO GRANADA
Official's Role
Study Director
Facility Information:
Facility Name
Complejo Hospitalario Universitario Granada
City
Granada
State/Province
SPA
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JUANA MARIA DE HARO CASTELLANO
Phone
+34958 020124
Email
juanam.haro.exts@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
JUAN MORALES ARCAS
Phone
+34 958 023136
Email
juan.morales.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
NICOLAS PRADOS OLLETA, PhD
First Name & Middle Initial & Last Name & Degree
PABLO TOMAS MUÑOZ

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
16045848
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.
Results Reference
result
PubMed Identifier
23636185
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.
Results Reference
result
PubMed Identifier
27037432
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.
Results Reference
result
PubMed Identifier
17515235
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.
Results Reference
result

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Blind and Ultrasound Guided Injection in Morton Neuroma

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