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
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
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
NCT ID
NCT02907671
First Posted
September 10, 2016
Last Updated
April 17, 2018
Sponsor
Rehabilitace MUDr. Hasan Mezian s.r.o.
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
Learn more about this trial
Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome
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