Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032227
Status:
COMPLETED
Last Update Posted:
2013-05-07
First Post:
2002-03-12
Brief Title:
Carpal Tunnel Syndrome Diagnosis and Treatment Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Carpal Tunnel Syndrome Diagnosis and Treatment Trial
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-075 | US NIH GrantContract | None | httpsreporternihgovquickSearchP60AR048093 |
| P60AR048093 | NIH | None | None |