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

NCT02219555 | Completed

• 1 other identifier: 14-003444
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel

Keywords

Carpal tunnel

Outcome Measures

Primary Outcomes (1)

• Changes in CTSAQ symptom score

  A change from baseline scores will be used to assess outcome

  Baseline - 12 months

Secondary Outcomes (3)

• Changes in Hand/wrist pain by VAS

  Baseline - 12 month

• Change in CTSAQ function score

  Baseline - 12 month

• Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring

  Baseline - 12 month

Study Arms (2)

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

Drug: Steroid Injection

Surgical treatment

When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician

Procedure: Carpel Tunnel surgery

Interventions

Steroid Injection DRUG

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

Non-surgical treatment

Carpel Tunnel surgery PROCEDURE

Standard of care carpel tunnel surgery

Surgical treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Median Neuropathy

Interventions

Steroids

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Peter Amadio, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 19, 2014
• Study Start: September 1, 2014
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

US (1)