Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

March 8, 2011 updated by: Vanderbilt University

This study will investigate whether symptomatic improvement following carpal tunnel corticosteroid injection can be correlated to symptomatic improvement following carpal tunnel release and therefore serve as a prognostic indicator.

Clinical question: Does response to corticosteroid injection in CTS predict outcomes of surgical treatment?

Secondary Questions:

  1. Can we confirm previous retrospectively collected data that a certain percentage of conservatively managed patients with steroid injection will avoid surgery, and that patients who undergo surgery will have better outcomes than those who do not.
  2. Are there differences between worker's compensation and non-worker's compensation patients with regard to the primary clinical question?
  3. What are Carpal Tunnel Release outcomes for the subset of patients with negative electrophysiologic studies?
  4. What are the outcomes of patients who undergo carpal tunnel release vs. those who choose not to undergo carpal tunnel release?

A prospective cohort design study is the appropriate study design in order to measure the association between a predictor (response to injection) and outcome (response to surgery).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Carpal Tunnel Syndrome is a painful condition that is caused by compression of the median nerve in the wrist. Symptoms usually are pain, weakness, or numbness in the hand and wrist, radiating up the arm. Corticosteroid injections have been utilized in the conservative management of carpal tunnel syndrome for several decades. They have been shown to be relatively safe with a very low reported complication rate. Recent efforts in the literature have shown they are efficacious for a majority of patients although their effects are usually transient. Several studies have attempted to show a predictive value of corticosteroid injection with regard to who will ultimately benefit from carpal tunnel release. There is a trend towards positive predictability with several retrospective studies showing that patients who have a clinical benefit from steroid injection are more likely to have a successful outcome from carpal tunnel release. Carpal tunnel release remains the definitive treatment option for carpal tunnel syndrome, and a clinical test which could give the practitioner and patient additional information regarding likelihood of successful outcome of surgery would be a valuable prognostic tool.

Study Type

Observational

Enrollment (Anticipated)

200

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

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8828
        • Vanderbilt Hand & Upper Extremity Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome

Description

Inclusion Criteria:

  • Patients with a clinical diagnosis of carpal tunnel syndrome
  • English speaking patients only

Exclusion Criteria:

  • Patients less than 18 years old
  • Patients who are pregnant by patient report or intending to become pregnant during the study
  • Patients unwilling or unable to return for follow-up visits prescribed by the study protocol.
  • Patients who qualify for inclusion in the study, but refuse to participate.
  • Patients with evidence of thenar atrophy on exam
  • Patients with a diagnosis of peripheral neuropathy or other neuropathy.
  • Patients with previous ipsilateral carpal tunnel injection or release.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Injection Patients
Those patients who receive corticosteroid injections for carpal tunnel syndrome
Other: Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine
Patients will receive a carpal tunnel injection of 1 mg of betamethasone and 1 mL of 1% lidocaine will be infiltrated by small gauge (ie. 25- or 27-gauge) needle via attending surgeon preference. These are routinely performed by injecting 1cm proximal to distal wrist crease just ulnar to palmaris longus tendon although multiple techniques have been described. Elicitation of median nerve symptoms during needle placement requires redirecting needle prior to injection to avoid median nerve infiltration.

Collaborators and Investigators

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

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Jeffry T Watson, M.D., Vanderbilt University

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

December 1, 2007

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (ESTIMATE)

April 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2011

Last Update Submitted That Met QC Criteria

March 8, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 071107

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.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe