Corticosteroid Injection as a Predictor of Outcome in Carpal Tunnel Release

NCT00655915 | Terminated

• 1 other identifier: 071107
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Are there differences between worker's compensation and non-worker's compensation patients with regard to the primary clinical question?
3. 3.What are Carpal Tunnel Release outcomes for the subset of patients with negative electrophysiologic studies?
4. 4.What are the outcomes of patients who undergo carpal tunnel release vs. those who choose not to undergo carpal tunnel release?

Conditions

Carpal Tunnel Syndrome

Study Arms (1)

Injection Patients

Those patients who receive corticosteroid injections for carpal tunnel syndrome

Other: Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine

Interventions

Corticosteroid Injection- 1ml of Betamethasone and 1 ml of 1% Lidocaine OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome

You may qualify if:

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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Hand & Upper Extremity Center

Nashville, Tennessee, 37232-8828, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Adrenal Cortex Hormones; Betamethasone; Lidocaine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jeffry T Watson, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 10, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 9, 2011

Record last verified: 2011-03

Locations

US (1)