Carpal Tunnel Syndrome Diagnosis and Treatment Trial

Completed

• Conditions: Carpal tunnel syndrome; Musculoskeletal Diseases

• Registration Number: ISRCTN84286481
• Lead Sponsor: ational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients with mild to moderate carpal tunnel syndrome confirmed by electrodiagnostic study (EDS) testing
2. Must have symptoms in at least 2 digits
3. Must have completed at least a 2 week trial of standard therapy without improvement as documented by at least one of the following:
a. Improvement less than 0.75 in the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ) functional scale
b. Unable to achieve satisfactory level of work
c. Patient defined symptoms as being same or worse over the last two weeks
4. EDS CRITERIA:
i. Median motor latency (wrist) =4.4 ms
ii. Sensory: Medial-radial (10 cm thumb to wrist) difference >0.5 ms
iii. Sensory: Midpalm median-ulnar (8 cm) difference >0.3 ms
iv. Sensory: Median-ulnar (14 cm digit IV to wrist) difference >0.4 ms
v. Sensory: Combined Sensory Index =1.0 ms
5. Or normal EDS with night pain that wakes patient AND Positive Flick Test
6. Other inclusion criteria:
Classic, probable or possible hand diagram
7. Willing to schedule surgery within one week of randomisation

Exclusion Criteria

Patients with evidence of severe CTS on EDS, EMG, or clinical findings are excluded from the study. Severe CTS is defined as a median motor amplitude of </= 3.8 mV, EMG evidence of denervation, or thenar atrophy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified