NCT00987571

Brief Summary

Carpal tunnel syndrome is caused by compression of the median nerve at the wrist. The hypothesis is that ultrasound imaging can be used to visualize nerve compression in carpal tunnel patients during hand activity, and normal subjects will not demonstrate any nerve compression.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

September 29, 2009

Last Update Submit

September 30, 2009

Conditions

Keywords

carpal tunnel syndromemedian nerveultrasoundelectrodiagnosisNormal subjects

Outcome Measures

Primary Outcomes (1)

  • Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients

    5 months

Secondary Outcomes (1)

  • No median nerve compressive narrowing in normal subjects

    5 months

Study Arms (2)

Carpal Tunnel patients

These patients have documented carpal tunnel syndrome

Normal Subjects

These individuals have no carpal tunnel syndrome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with upper extremity symptoms of pain, numbness, and tingling; Adult subjects with no upper extremity pain, numbness, or tingling

You may qualify if:

  • Patients must have symptoms consistent with carpal tunnel syndrome and electrodiagnostic testing that demonstrates abnormal median nerve function at the wrist, consistent with carpal tunnel syndrome.
  • Normal subjects must have no upper limb symptoms to support carpal tunnel syndrome and normal nerve testing.

You may not qualify if:

  • Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
  • Normals excluded if nerve testing demonstrated any median nerve abnormality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Benjamin M Sucher, DO

    EMG Labs of AARA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2009

First Posted

October 1, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 1, 2009

Record last verified: 2009-09