Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome

April 17, 2018 updated by: Rehabilitace MUDr. Hasan Mezian s.r.o.

Effectiveness of Ultrasound Guided Corticoanesthetic Injection in Carpal Tunnel Syndrome Comparing Two Different Injection Sites

Effectiveness of ultrasound guided corticoanesthetic injection in carpal tunnel syndrome treatment comparing two different injection sites. Single-blind randomized trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Litomerice, Czechia, 41201
    • Czech Republic
      • Litoměřice, Czech Republic, Czechia, 41201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
carpal tunnel corticoanesthetic injection between the flexor tendons
Procedure: carpal tunnel corticoanesthetic injection
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
Other Names:
  • injetion with corticosteroid and local aneshtetics
Active Comparator: Group B
carpal tunnel corticoanesthetic injection next to the median nerve with hydrodissection
Procedure: carpal tunnel corticoanesthetic injection
Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
Other Names:
  • injetion with corticosteroid and local aneshtetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale
Time Frame: up to 1 year
pain severity scale
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michigan Hand Outcomes Measure
Time Frame: up to 1 year
Hand function status
up to 1 year
Boston carpal tunnel questionnaire
Time Frame: up to 1 year
Hand function status
up to 1 year
Procedural CAS
Time Frame: up to 1 year
discomfort during the internetion
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehabilitace MUDr. Hasan Mezian s.r.o.

Investigators

  • Principal Investigator: Kamal Mezian, M.D., 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 10, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111 (Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication in the relevant journal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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