- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219555
DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome (DUCATS)
May 13, 2021 updated by: Peter C. Amadio, M.D., Mayo Clinic
The purpose of this study is to learn if researchers can identify through ultrasound images and clinical assessment which subjects with carpel tunnel syndrome will do better following standard of care non-surgical or surgical treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
204
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be identified among those presenting to the Hand Clinic with a referral diagnosis of CTS, and from those referred for EDS with a referral diagnosis of CTS, who are clinically indicated for either a steroid injection or surgery.
Those who meet these and the inclusion criteria, do not meet the exclusion criteria, and who consent to participate will be entered in the study.
Description
The following criteria must be answered yes to be enrolled:
- Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)?
- Is the patient an adult between the ages of 21 and 80?
- Has the patient had symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long or radial border of ring finger?
- Does the patient have a clinical diagnosis of carpal tunnel syndrome?
- Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be positive>)
- Is the patient able to understand and complete the study questionnaires and medical assessments in English?
- Is the patient clinically indicated for treatment with either a steroid injection or surgery as treatment for their CTS?
EXCLUSION CRITERIA The following questions if answered yes will exclude the patient from participation in the study.
- Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand?
- Does the patient have a known tumor, mass or deformity of the study hand or wrist?
- Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)?
Does the patient have any of the following diagnoses or conditions:
- cervical radiculopathy
- rheumatoid arthritis or other inflammatory arthritis, including gout
- osteoarthritis in the wrist
- renal failure
- morbid obesity (body mass index >40)
- sarcoidosis
- peripheral nerve disease
- Diabetes
- thyroid disease or other metabolic disorder
- pregnancy
- amyloidosis
- major trauma (fractures or complete ligamentous tears) to the study hand or wrist?
- Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Non-surgical treatment
When clinically indicated, subjects will receive a standard of care carpal tunnel injection whose volume and specific steroid drug will be based on the recommendation of the treating clinician
|
volume and specific steroid drug will be based on the recommendation of the treating clinician
|
Surgical treatment
When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician
|
Standard of care carpel tunnel surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in CTSAQ symptom score
Time Frame: Baseline - 12 months
|
A change from baseline scores will be used to assess outcome
|
Baseline - 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Hand/wrist pain by VAS
Time Frame: Baseline - 12 month
|
A change from baseline will be used to assess outcome
|
Baseline - 12 month
|
Change in CTSAQ function score
Time Frame: Baseline - 12 month
|
A change from baseline will be used to assess outcome
|
Baseline - 12 month
|
Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring
Time Frame: Baseline - 12 month
|
CES-D questionnaire scoring will be used to assess outcomes
|
Baseline - 12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Amadio, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
August 15, 2020
Study Completion (Actual)
August 15, 2020
Study Registration Dates
First Submitted
August 16, 2014
First Submitted That Met QC Criteria
August 18, 2014
First Posted (Estimate)
August 19, 2014
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 13, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-003444
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
Stanford UniversityMayo Clinic; Brown University; Duke University; Harvard University; University of...CompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
CMC Ambroise ParéCompletedCarpal Tunnel ReleaseFrance
-
Vanderbilt UniversityOrthopedic Research and Education FoundationCompleted
-
Istituto Ortopedico RizzoliCompletedEntrapment Neuropathy, Carpal Tunnel | Compression Neuropathy, Carpal Tunnel | Median Neuropathy, Carpal TunnelItaly
-
University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
University of Split, School of MedicineCompletedCarpal Tunnel Syndrome BilateralCroatia
-
Ohio State UniversityCompletedBilateral Carpal Tunnel Syndrome (Diagnosis)United States
-
Centre Hospitalier Saint Joseph Saint Luc de LyonRecruitingCarpal Tunnel Syndrome BilateralFrance
-
Hospital Italiano de Buenos AiresWithdrawn
Clinical Trials on Steroid Injection
-
Johns Hopkins UniversityWithdrawn
-
Blackpool Teaching Hospitals NHS Foundation TrustNot yet recruitingShoulder Subacromial Pain SyndromeUnited Kingdom
-
Istanbul Medeniyet UniversityMarmara UniversityRecruitingLumbosacral RadiculopathyTurkey
-
Franklin Pierce UniversityUniversity of Colorado, DenverCompletedLumbar Spinal StenosisUnited States
-
Samsung Medical CenterCompletedTrigger FingerKorea, Republic of
-
National Taiwan University HospitalCompletedSwallowing FunctionTaiwan
-
Seoul National University Bundang HospitalCompletedIncidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large PopulationKorea, Republic of
-
Gangnam Severance HospitalCompletedAutoimmune Bullous DiseaseKorea, Republic of
-
Columbia UniversityCompleted
-
Seoul National University Bundang HospitalCompleted