A Study Using Dynamic Ultrasound to Enhance the Understanding of Carpal Tunnel Syndrome
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003444
NCT ID: NCT02219555
Sponsor Protocol Number: 14-003444
About this study
The purpose of this study is to use ultrasound to detect variations in nerve, tendon and subsynovial connective tissue mobility in patients with carpal tunnel syndrome may be useful as functional biomarkers that serve as predictors for treatment response. To test this patients presenting for treatment of carpal tunnel syndrome will be monitored by ultrasound and by clinical assessment before and after non-surgical and surgical treatment. The clinical outcomes will be alined with the initial ultrasound motion patterns.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Has clinical symptoms of Carpal Tunnel Syndrome (CTS)
- Ages 21 to 80
- Has had 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
- Has a clinical diagnosis of carpal tunnel syndrome
- Has had an electrodiagnostic study or EMG? (Does not need to be positive)
- Able to understand and complete the study questionnaires and medical assessments in English
- Is clinically indicated for treatment with either a steroid injection or surgery as treatment for their CTS
EXCLUSION CRITERIA
- Has had previous carpal tunnel release or other volar wrist surgery on the hand
- Has a known tumor, mass or deformity of the study hand or wrist
- Has a previous history of steroid injection into the carpal tunnel (injection group only)
- Has any of the following diagnoses or conditions
- Cervical radiculopathy
- Rheumatoid arthritis or other inflammatory arthritis, including gout
- Osteoarthritis in the wrist
- Renal failure
- Sarcoidosis
- Peripheral nerve disease
- Diabetes
- Uncontrolled thyroid disease or other metabolic disorder
- Thyroid cancer does not exclude
- Pregnancy
- Amyloidosis
- Major trauma (fractures or complete ligamentous tears) to the study hand or wrist
- Is a prisoner, institutionalized individual or someone who could be considered a vulnerable person, such as an individual with dementia
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Peter Amadio, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available