Carpal Tunnel SyndromeNCT00987571
Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression
An observational study of Carpal Tunnel Syndrome, run by EMG Labs of Arizona Arthritis & Rheumatology Associates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with upper extremity symptoms of pain, numbness, and tingling; Adult subjects with no upper extremity pain, numbness, or tingling
Who may be able to join
- 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.
Who cannot join
- Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
- Normals excluded if nerve testing demonstrated any median nerve abnormality.
About this study
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.
Read the detailed description
Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, median nerve, ultrasound, electrodiagnosis, Normal subjects
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel patients | These patients have documented carpal tunnel syndrome | |
| Normal Subjects | These individuals have no carpal tunnel syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients
Measured: 5 months
Secondary outcomes (1)
No median nerve compressive narrowing in normal subjects
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMG Labs of Arizona Arthritis & Rheumatology Associates
- Sponsor type
- University, hospital or other
- Investigators
- Benjamin M Sucher, DO, Principal investigator, EMG Labs of AARA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987571
- Sponsor's protocol ID
- CTS-US Med N JAOA
- Status last verified
- Sep 2009
- First submitted
- 29 Sep 2009
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Syndrome: Case Reports and Analysis - Ultrasound Imaging and Pathomechanics of Median Nerve Compression
- ClinicalTrials.gov ID
- NCT00987571
- Acronym / sponsor ID
- CTS-US Med N JAOA
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, median nerve, ultrasound, electrodiagnosis, Normal subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- EMG Labs of Arizona Arthritis & Rheumatology AssociatesUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Two patients with carpal tunnel syndrome underwent nerve testing to document that they had median nerve abnormality at the wrist. They subsequently had ultrasound imaging of the wrist at rest and during a stress test using hand activity. Two control subjects had nerve testing to prove that they had no nerve abnormality at the carpal tunnel. The carpal tunnel syndrome patients demonstrated nerve compression on the ultrasound images during the stress tests and the normal subjects showed no nerve compression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel patients | – | –These patients have documented carpal tunnel syndrome |
| Normal Subjects | – | –These individuals have no carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with upper extremity symptoms of pain, numbness, and tingling; Adult subjects with no upper extremity pain, numbness, or tingling
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients excluded if nerve testing was not consistent with carpal tunnel syndrome.
- Normals excluded if nerve testing demonstrated any median nerve abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients
Time frame: 5 months
1 secondary outcome
No median nerve compressive narrowing in normal subjects
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin M Sucher, DO principal investigator
EMG Labs of AARA
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by EMG Labs of Arizona Arthritis & Rheumatology Associates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median nerve compressive narrowing on ultrasound imaging in carpal tunnel syndrome patients (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009.