Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

This study has been terminated.
(Study was terminated by principal investigator)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00655915
First received: March 28, 2008
Last updated: March 8, 2011
Last verified: March 2011

March 28, 2008
March 8, 2011
December 2007
March 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00655915 on ClinicalTrials.gov Archive Site
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Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release
Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome

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.
Injection Patients
Those patients who receive corticosteroid injections for carpal tunnel syndrome
Intervention: Other: Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00655915
071107
No
Jeffry T. Watson, MD / Assistant Professor of Orthopaedic Surgery, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Jeffry T Watson, M.D. Vanderbilt University
Vanderbilt University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP