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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00655915 |
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:
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 |
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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 |
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 |
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Injection Patients
Those patients who receive corticosteroid injections for carpal tunnel syndrome
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients who present to Vanderbilt Hand Center with carpal tunnel syndrome
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Brandon Ramo, M.D. | Vanderbilt University |
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 |
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 |
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 |