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Completed

NCT Number: NCT02219555

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

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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Steroid Injection

Drug

volume and specific steroid drug will be based on the recommendation of the treating clinician

Carpel Tunnel surgery

Procedure

Standard of care carpel tunnel surgery

Primary outcomes

  1. Changes in CTSAQ symptom score

    Time frame: Baseline - 12 months

    A change from baseline scores will be used to assess outcome

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Acronym: DUCATS

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2014
Registry last updated
May 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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