Carpal TunnelDUCATSNCT02219555
DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
An observational study of Carpal Tunnel, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Carpal Tunnel
- What is being tested?
- Steroid Injection and Carpel Tunnel surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 15 Aug 2020
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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?
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Carpal Tunnel
- Being tested
- Steroid Injection, Carpel Tunnel surgery
- Keywords
- Carpal tunnel
- Medical subject headings
- Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid InjectionDrug
volume and specific steroid drug will be based on the recommendation of the treating clinician
Carpel Tunnel surgeryProcedure or surgery
Standard of care carpel tunnel surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Steroid Injection | |
| Surgical treatment | When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician Receives: Procedure: Carpel Tunnel surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CTSAQ symptom score
A change from baseline scores will be used to assess outcome
Measured: Baseline - 12 months
Secondary outcomes (3)
Changes in Hand/wrist pain by VAS
A change from baseline will be used to assess outcome
Measured: Baseline - 12 month
Change in CTSAQ function score
A change from baseline will be used to assess outcome
Measured: Baseline - 12 month
Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring
CES-D questionnaire scoring will be used to assess outcomes
Measured: Baseline - 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal TunnelStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter C. Amadio, M.D., Mayo Clinic
- Investigators
- Peter Amadio, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219555
- Sponsor's protocol ID
- 14-003444
- Acronym
- DUCATS
- Status last verified
- May 2021
- First submitted
- 16 Aug 2014
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT02219555
- Acronym / sponsor ID
- DUCATS / 14-003444
- Conditions
- Carpal Tunnel
- Keywords
- Carpal tunnel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 19 Aug 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical treatment | – | Drug: Steroid InjectionWhen 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 |
| Surgical treatment | – | Procedure: Carpel Tunnel surgeryWhen clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroid Injectionvolume and specific steroid drug will be based on the recommendation of the treating clinician | Drug | Non-surgical treatment |
| Carpel Tunnel surgeryStandard of care carpel tunnel surgery | Procedure or surgery | Surgical treatment |
Primary outcome
Changes in CTSAQ symptom score
Time frame: Baseline - 12 months
A change from baseline scores will be used to assess outcome
3 secondary outcomes
Changes in Hand/wrist pain by VAS
Time frame: Baseline - 12 month
Change in CTSAQ function score
Time frame: Baseline - 12 month
Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring
Time frame: Baseline - 12 month
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 17 May 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Carpal Tunnel
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Peter Amadio, MD principal investigator
Mayo Clinic
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, run by Mayo Clinic 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?
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 17 May 2021. 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?
Changes in CTSAQ symptom score (time frame: Baseline - 12 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 17 May 2021.