Carpal Tunnel SyndromeNCT02038205
Ultrasonographic Measurements of the Median Nerve Before and After Splinting for Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by University of California, Davis at 1 site in United States.
Trial summary
A prospective cohort follow-up study design is undertaken. Both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. Controls will also be seen for a one time visit. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those with diagnosis of carpal tunnel syndrome, and healthy control subjects with no symptoms of CTS.
Who may be able to join
- 18 years or older and;
- Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing
- Control subjects without symptoms of carpal tunnel syndrome.
Who cannot join
- Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
- Untreated hypothyroidism, Rheumatologic disorders
- Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
- Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.
- Currently pregnant or < 3 months post partum
- History of wrist, hand fracture or severe trauma to affected hand and/or wrist
Show all 13Show fewer
- Known tumor, mass or deformity of the hand/wrist
- Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
- History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
- Diagnosed neuromuscular disorders which may complicate CTS diagnosis
- Implanted electronic device (pacemaker, intrathecal pump/stimulator)
- Any illness that makes it unsafe for the patient to participate in the study
- Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome
A prospective cohort follow-up study design is undertaken. Both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. Controls will also be seen for a one time visit.
- Conditions
- Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross sectional area of median nerve using ultrasound
Measured: 6 weeks
Secondary outcomes (3)
Patient-reported outcome measures using NeuroQOL and CTSAQ
Measured: 6 weeks
Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study
Measured: 6 weeks
cross sectional area, electrodiagnostic study, age, gender, height, weight, BMI, wrist circumference, wrist width. smoking and handedness as predictors of improvement (or no improvement) in the NeuroQOL and CTSAQ-measured clinical severity scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionNov 2016
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanette Joyce, DO, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038205
- Sponsor's protocol ID
- 336315
- Status last verified
- Feb 2017
- First submitted
- 7 Jan 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02038205
- Acronym / sponsor ID
- 336315
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Jan 2014 (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.
A prospective cohort follow-up study design is undertaken. Both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. Controls will also be seen for a one time visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those with diagnosis of carpal tunnel syndrome, and healthy control subjects with no symptoms of CTS.
Key inclusion criteria (3 listed)
- 18 years or older and;
- Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing
- Control subjects without symptoms of carpal tunnel syndrome.
Key exclusion criteria (13 listed)
- Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
- Untreated hypothyroidism, Rheumatologic disorders
- Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
- Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.
- Currently pregnant or < 3 months post partum
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
Cross sectional area of median nerve using ultrasound
Time frame: 6 weeks
3 secondary outcomes
Patient-reported outcome measures using NeuroQOL and CTSAQ
Time frame: 6 weeks
Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study
Time frame: 6 weeks
cross sectional area, electrodiagnostic study, age, gender, height, weight, BMI, wrist circumference, wrist width. smoking and handedness as predictors of improvement (or no improvement) in the NeuroQOL and CTSAQ-measured clinical severity scale.
Time frame: 6 weeks
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 23 Feb 2017.
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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.
Nanette Joyce, DO principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by University of California, Davis at 1 site in United States.
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 3 inclusion and 13 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cross sectional area of median nerve using ultrasound (time frame: 6 weeks). 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 23 Feb 2017.