Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
Summary
The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.
Description
While there is good evidence that patients with severe CTS benefit from surgery, there is less evidence of a benefit for patients with mild to moderate disease. However, mild to moderate disease still accounts for important disability. Electrodiagnostic studies (EDS) have not been shown to accurately predict outcomes for patients with CTS. Recent advances in MR permit high-resolution neurographic imaging of the median nerve, and pilot data suggest that wrist MRI might be a better predictor of outcome than EDS. Thus, wrist MRI has the potential for playing a major role in the treatment of patients with CTS. We will test two main hypotheses: 1) that select patients with early, mild or moderate CTS benefit more from early surgery than with conservative therapy; and, 2) that wrist MRI accurately identifies those patients more likely to benefit from surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Carpal Tunnel Syndrome
Intervention
Early Carpal Tunnel Release for Mild or Moderate CTS, MR Nerve Imaging for CTS
Location
University of Washington Medical Center
Seattle
Washington
United States
98104
Status
Completed
Source
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00032227
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Carpal Tunnel Syndrome
Entrapment of the MEDIAN NERVE in the carpal tunnel, which is formed by the flexor retinaculum and the CARPAL BONES. This syndrome may be associated with repetitive occupational trauma (CUMULATIVE TRAUMA DISORDERS); wrist injuries; AMYLOID NEUROPATHIES; rheumatoid arthritis (see ARTHRITIS, RHEUMATOID); ACROMEGALY; PREGNANCY; and other conditions. Symptoms include burning pain and paresthesias involving the ventral surface of the hand and fingers which may radiate proximally. Impairment of sensation in the distribution of the median nerve and thenar muscle atrophy may occur. (Joynt, Clinical Neurology, 1995, Ch51, p45)
Median Neuropathy
Disease involving the median nerve, from its origin at the BRACHIAL PLEXUS to its termination in the hand. Clinical features include weakness of wrist and finger flexion, forearm pronation, thenar abduction, and loss of sensation over the lateral palm, first three fingers, and radial half of the ring finger. Common sites of injury include the elbow, where the nerve passes through the two heads of the pronator teres muscle (pronator syndrome) and in the carpal tunnel (CARPAL TUNNEL SYNDROME).
Amyloid Neuropathies
Disorders of the peripheral nervous system associated with the deposition of AMYLOID in nerve tissue. Familial, primary (nonfamilial), and secondary forms have been described. Some familial subtypes demonstrate an autosomal dominant pattern of inheritance. Clinical manifestations include sensory loss, mild weakness, autonomic dysfunction, and CARPAL TUNNEL SYNDROME. (Adams et al., Principles of Neurology, 6th ed, p1349)
Tarsal Tunnel Syndrome
Entrapment of the distal branches of the posterior TIBIAL NERVE (which divides into the medial plantar, lateral plantar, and calcanial nerves) in the tarsal tunnel, which lies posterior to the internal malleolus and beneath the retinaculum of the flexor muscles of the foot. Symptoms include ankle pain radiating into the foot which tends to be aggravated by walking. Examination may reveal Tinel's sign (radiating pain following nerve percussion) over the tibial nerve at the ankle, weakness and atrophy of the small foot muscles, or loss of sensation in the foot. (From Foot Ankle 1990;11(1):47-52)
Molecular Imaging
The use of molecularly targeted imaging probes to localize and/or monitor biochemical and cellular processes via various imaging modalities that include RADIONUCLIDE IMAGING; ULTRASONOGRAPHY; MAGNETIC RESONANCE IMAGING; fluorescence imaging; and MICROSCOPY.
Clinical Trials
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment. Diagnosis is based on symptoms, clinical findings and electrophysiological examination. Several conservative an...
Nerve Entrapment in Diabetic Patients
The aim of this study is in a prospective, consecutive series of diabetic patients with carpal tunnel syndrome, who are then age and gender matched with non-diabetic patients having idiopa...
Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
To investigate the efficacy of acupuncture compared with steroid treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve conducti...
Post-operative Mobilization for Carpal Tunnel Syndrome
This study will investigate the effect of one week of immobilization following carpal tunnel release surgery versus no immobilization.
Early Motion Following Carpal Tunnel Release
To objectively and subjectively assess two modes of commonly employed rehabilitation and confirm a superior method to treat patients following carpal tunnel release. One of the problems f...
PubMed Articles
Carpal tunnel pressure measurement during two-portal endoscopic carpal tunnel release.
BACKGROUND: Although there remain concerns of median nerve damage during endoscopic carpal tunnel release for carpal tunnel syndrome, carpal tunnel pressure variations during Chow's two-portal techini...
Bilateral carpal tunnel syndrome with anomalous palmaris profundus tendons.
Abstract This report presents the case of a 44-year-old man who presented with elective bilateral carpal tunnel decompression. At the operation, he was found to have bilateral palmaris profundus tendo...
Limited portal carpal tunnel release : An alternative to classic open release?
The aim of this study was to determine the significance of limited portal carpal tunnel release compared to the classic open approach. We present a retrospective comparative clinical trial including 1...
Ultrasound-guided carpal tunnel release using the manos CTR system.
PURPOSE: Ultrasound (US) has been used in the management of carpal tunnel syndrome since the 1980s. The first report of US-guided carpal tunnel release (CTR) was published in 1997, with cadaver and cl...
PURPOSE: The purpose of this study was to evaluate the effects of epineurotomy on the post-surgical median nerve volume and clinical outcomes in carpal tunnel syndrome (CTS) patients with a prominent...