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Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
carpal tunnel corticoanesthetic injection
Sponsored by
Rehabilitace MUDr. Hasan Mezian s.r.o.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel injection, corticosteroid, ultrasound-guided, musculoskeletal ultrasound

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary idiopathic CTS
  • symptoms of classic or probable CTS (numbness or tingling in at least 2 of the 4 radial fingers)
  • unsuccessful 1-month treatment with wrist splinting
  • nerve conduction test results that showed median neuropathy at the wrist

Exclusion Criteria:

  • previous steroid injection
  • diabetes mellitus,
  • thyroid disorder
  • inflammatory disease
  • polyneuropathy
  • current pregnancy
  • previous carpal tunnel surgery
  • severe illness
  • inability to respond to questionnaires

Sites / Locations

  • Kamal MezianRecruiting
  • Kamal MezianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

carpal tunnel corticoanesthetic injection between the flexor tendons

carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection

Outcomes

Primary Outcome Measures

Visual analogue scale
pain severity scale

Secondary Outcome Measures

Michigan Hand Outcomes Measure
Hand function status
Boston carpal tunnel questionnaire
Hand function status
Procedural CAS
discomfort during the internetion

Full Information

First Posted
September 10, 2016
Last Updated
April 17, 2018
Sponsor
Rehabilitace MUDr. Hasan Mezian s.r.o.
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1. Study Identification

Unique Protocol Identification Number
NCT02907671
Brief Title
Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome
Official Title
Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rehabilitace MUDr. Hasan Mezian s.r.o.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.
Detailed Description
Carpal tunnel syndrome (CTS) is the most common nerve entrapment neuropathy. Six placebo-controlled trials with 393 participants proved corticosteroid injection to be effective in symptom relief. However, all injections were palpation-guided. Therefore, the exact injection site was uncertain. Although three studies comparing palpation and ultrasound (US) guided CTS injection showed US superiority, the optimal injection site for the injectate delivery remains unclear. Some authors believe in thinning of the flexor tenosynovium as the mechanism of the median nerve decompression, and therefore recommend injection between the tendons, away from the nerve. Other authors stress the importance of hydrodissection and direct contact of the injectate with the nerve and suggest injection targeting the median nerve. According to our best knowledge, no study comparing different injection sites for a corticosteroid delivery in CTS has been published in English written literature. The objective of this study was to determine the optimal target site for the corticosteroid delivery in CTS injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel injection, corticosteroid, ultrasound-guided, musculoskeletal ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
carpal tunnel corticoanesthetic injection between the flexor tendons
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection
Intervention Type
Procedure
Intervention Name(s)
carpal tunnel corticoanesthetic injection
Other Intervention Name(s)
injetion with corticosteroid and local aneshtetics
Intervention Description
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
pain severity scale
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Michigan Hand Outcomes Measure
Description
Hand function status
Time Frame
up to 1 year
Title
Boston carpal tunnel questionnaire
Description
Hand function status
Time Frame
up to 1 year
Title
Procedural CAS
Description
discomfort during the internetion
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary idiopathic CTS symptoms of classic or probable CTS (numbness or tingling in at least 2 of the 4 radial fingers) unsuccessful 1-month treatment with wrist splinting nerve conduction test results that showed median neuropathy at the wrist Exclusion Criteria: previous steroid injection diabetes mellitus, thyroid disorder inflammatory disease polyneuropathy current pregnancy previous carpal tunnel surgery severe illness inability to respond to questionnaires
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamal Mezian, M.D.
Phone
00420603313207
Email
kamal.mezian@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Mezian, M.D.
Organizational Affiliation
Czech Technical University in Prague, Faculty of Biomedical Engineering, Department of Health Care Disciplines and Population Protection, Sportovců 2311, 272 01 Kladno city, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamal Mezian
City
Litoměřice
State/Province
Czech Republic
ZIP/Postal Code
41201
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal Mezian
Phone
603313207
Email
kamal.mezian@gmail.com
Facility Name
Kamal Mezian
City
Litomerice
ZIP/Postal Code
41201
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamal Mezian
Phone
00420603313207
Email
kamal.mezian@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication in the relevant journal
Citations:
PubMed Identifier
27144462
Citation
Mezian K, Bruthans J. Why do local corticosteroid injections work in carpal tunnel syndrome, But not in ulnar neuropathy at the elbow? Muscle Nerve. 2016 Aug;54(2):344. doi: 10.1002/mus.25171. Epub 2016 May 26. No abstract available.
Results Reference
result
PubMed Identifier
26506508
Citation
Podnar S, Omejec G. Why do local corticosteroid injections work in carpal tunnel syndrome, but not in ulnar neuropathy at the elbow? Muscle Nerve. 2016 Apr;53(4):662-3. doi: 10.1002/mus.24956. No abstract available.
Results Reference
result
PubMed Identifier
27144365
Citation
Bodor M, Rojo-Manaute JM, Podnar S. Reply. Muscle Nerve. 2016 Aug;54(2):344-5. doi: 10.1002/mus.25170. No abstract available.
Results Reference
result

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Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome

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