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DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome (DUCATS)

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ClinicalTrials.gov Identifier: NCT02219555
Recruitment Status : Recruiting
First Posted : August 19, 2014
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Peter C. Amadio, M.D., Mayo Clinic

Brief Summary:
We hypothesize that the ultrasound detectable variations in nerve, tendon and SSCT mobility in patients with CTS may be useful clinically, not to diagnose CTS, but instead as functional biomarkers that correlate with, and thereby serve as predictors for, treatment response. To test this hypothesis, we propose a longitudinal clinical study in which patients presenting for treatment of CTS will be monitored by ultrasound and by clinical assessment before and after non-surgical and surgical treatment. We will correlate the clinical outcomes with the initial ultrasound motion patterns that we have found to be most variable in CTS patients. We will also test the hypothesis that successful treatment results in a change towards normal in the affected ultrasound variables.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Drug: NaCl and lidocaine placebo/salt water Drug: triamcinolone acetonide, lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome
Study Start Date : September 2014
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Placebo Comparator: Randomized Placebo/salt water injection
1ml of 0.9% NaCl and 2 ml of 1% lidocaine placebo/salt water injection at the time of enrollment into the study. If patient had an injection but continues to have ongoing symptoms, they and their doctor will be free to choose any treatment for carpal tunnel syndrome, including either a second injection which would be the active drug, surgery or any other choice that they and their doctor agree to
Drug: NaCl and lidocaine placebo/salt water
1ml of 0.9% NaCl and 2 ml of 1% lidocaine placebo/salt water injection at the time of enrollment into the study. If patient had an injection but continues to have ongoing symptoms, they and their doctor will be free to choose any treatment for carpal tunnel syndrome, including either a second injection which would be the active drug, surgery or any other choice that they and their doctor agree to
Other Name: Placebo/salt water injection

Active Comparator: Randomized Active medication injection
a mixture of one ml of triamcinolone acetonide, 240 mg/ml, and 2 ml of 1% lidocaine, active medication injection. If patient had an injection but continues to have ongoing symptoms, they and their doctor will be free to choose any treatment for carpal tunnel syndrome, including either a second injection which would be the active drug, surgery or any other choice that they and their doctor agree to
Drug: triamcinolone acetonide, lidocaine
a mixture of one ml of triamcinolone acetonide, 240 mg/ml, and 2 ml of 1% lidocaine, active medication injection. If patient had an injection but continues to have ongoing symptoms, they and their doctor will be free to choose any treatment for carpal tunnel syndrome, including either a second injection which would be the active drug, surgery or any other choice that they and their doctor agree to
Other Names:
  • Active medication injection
  • Steroid Injection
  • Triamcinolone acetonide

No Intervention: None Randomized observational medication injection
Observational: Active medication injection Patients without randomization where any type of injection as prescribed by the physician is accepted If patient had an injection but continues to have ongoing symptoms, they and their doctor will be free to choose any treatment for carpal tunnel syndrome, including either a second injection, surgery or any other choice that they and their doctor agree to
No Intervention: Observational: Surgical

Patients who are going to have carpel tunnel release surgery are eligible for this arm.

If patient has ongoing symptoms, they and their doctor will be free to choose any treatment for carpal tunnel syndrome.




Primary Outcome Measures :
  1. Changes in CTSAQ symptom score [ Time Frame: Baseline - 12 months ]
    A change from baseline scores will be used to assess outcome


Secondary Outcome Measures :
  1. Changes in Hand/wrist pain by VAS [ Time Frame: Baseline - 12 month ]
    A change from baseline will be used to assess outcome

  2. Change in CTSAQ function score [ Time Frame: Baseline - 12 month ]
    A change from baseline will be used to assess outcome

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The following criteria must be answered yes to be enrolled:

  1. Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)?
  2. Is the patient an adult between the ages of 21 and 80?
  3. 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?
  4. Does the patient have a clinical diagnosis of carpal tunnel syndrome?
  5. Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be positive>)
  6. Is the patient able to understand and complete the study questionnaires and medical assessments in English?
  7. 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.

  1. Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery on the hand?
  2. Does the patient have a known tumor, mass or deformity of the study hand or wrist?
  3. Does the patient have a previous history of steroid injection into the carpal tunnel (injection group only)?
  4. Does the patient have any of the following diagnoses or conditions:

    1. cervical radiculopathy
    2. rheumatoid arthritis or other inflammatory arthritis, including gout
    3. osteoarthritis in the wrist
    4. renal failure
    5. morbid obesity (body mass index >40)
    6. sarcoidosis
    7. peripheral nerve disease
    8. Diabetes
    9. thyroid disease or other metabolic disorder
    10. pregnancy
    11. amyloidosis
    12. major trauma (fractures or complete ligamentous tears) to the study hand or wrist?
  5. Is the patient a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219555


Contacts
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Contact: Peter C. Amadio, M.D. 507-284-2511
Contact: Jonathan D Furuseth 507-293-7393 furuseth.jonathan@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Peter C. Amadio, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Peter Amadio, MD Mayo Clinic

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Responsible Party: Peter C. Amadio, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02219555     History of Changes
Other Study ID Numbers: 14-003444
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Keywords provided by Peter C. Amadio, M.D., Mayo Clinic:
Carpal tunnel
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Anti-Inflammatory Agents
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists