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Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release
This study is currently recruiting participants.
Verified by Vanderbilt University, April 2009
First Received: March 28, 2008   Last Updated: April 10, 2009   History of Changes
Sponsored by: Vanderbilt University
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00655915
  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: Cohort, 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:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 200
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655915

Locations
United States, Tennessee
Vanderbilt Hand & Upper Extremity Center Recruiting
Nashville, Tennessee, United States, 37232-8828
Contact: Julie Daniels     615-322-4506     Julie.M.Daniels@vanderbilt.edu    
Principal Investigator: Brandon S Ramo, MD            
Sub-Investigator: Jeffry T Watson, MD            
Sub-Investigator: Douglas R Weikert, MD            
Sub-Investigator: Donald H Lee, MD            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Brandon Ramo, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Vanderbilt University Medical Center ( Brandon Ramo, MD / Orthopaedic Resident )
Study ID Numbers: 071107
Study First Received: March 28, 2008
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00655915     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Roussy Levy Hereditary Areflexic Dystasia
Carpal Tunnel Syndrome
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Disorders of Environmental Origin
Mononeuropathies
Hormones
Neuromuscular Diseases
Hereditary Motor and Sensory Neuropathies
Anti-Arrhythmia Agents
Betamethasone
Charcot Marie Tooth Disease
Betamethasone sodium phosphate
Charcot-Marie-Tooth Disease
Wounds and Injuries
Lidocaine
Central Nervous System Depressants
Anti-Asthmatic Agents
Cardiovascular Agents
Tomaculous Neuropathy
Glucocorticoids
Anesthetics, Local
Nerve Compression Syndromes
Sodium phosphate
Peripheral Nervous System Diseases
Peripheral Nervous System Agents
Sprains and Strains

Additional relevant MeSH terms:
Betamethasone-17,21-dipropionate
Anti-Inflammatory Agents
Respiratory System Agents
Carpal Tunnel Syndrome
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Disorders of Environmental Origin
Mononeuropathies
Hormones
Pathologic Processes
Neuromuscular Diseases
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Arrhythmia Agents
Betamethasone
Median Neuropathy
Disease
Betamethasone sodium phosphate
Nervous System Diseases
Wounds and Injuries
Lidocaine
Central Nervous System Depressants
Anti-Asthmatic Agents
Cardiovascular Agents
Glucocorticoids
Anesthetics, Local
Pharmacologic Actions
Nerve Compression Syndromes

ClinicalTrials.gov processed this record on September 09, 2009