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Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

This study has been terminated.
(Study was terminated by principal investigator)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655915
First Posted: April 10, 2008
Last Update Posted: March 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose

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).


Condition Intervention
Carpal Tunnel Syndrome Other: Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Estimated Enrollment: 200
Study Start Date: December 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655915


Locations
United States, Tennessee
Vanderbilt Hand & Upper Extremity Center
Nashville, Tennessee, United States, 37232-8828
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Jeffry T Watson, M.D. Vanderbilt University
  More Information

Responsible Party: Jeffry T. Watson, MD / Assistant Professor of Orthopaedic Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00655915     History of Changes
Other Study ID Numbers: 071107
First Submitted: March 28, 2008
First Posted: April 10, 2008
Last Update Posted: March 9, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Lidocaine
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones