Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

February 8, 2024 updated by: Elise Robben, KU Leuven
The general aim of this research is to gain insight in the role of SSCT in the etiology and progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and biomechanical characteristics. This eventually may lead to damage of the median nerve. To examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used First, the reliability of the US technique to characterize morphology of the SSCT will be investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS patients to provide descriptive parameters and to describe differences between patients and controls. In the final part a prospective study will be conducted to look at changes of SSCT thickness over time and after treatment.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects with and without carpal tunnel syndrome

Description

Inclusion Criteria:

  • For CTS patients
  • Human adults, 18 years and older
  • Complaints compatible with CTS (Katz Hand Diagram[31] rating of 'classic', 'probable' or 'possible' or typical clinical signs)
  • Indication for electrodiagnostic testing
  • Informed consent to participate
  • For Healthy subjects
  • Human adults, 18 years and older
  • Negative electrodiagnostic testing and scoring 'unlikely' at Katz Hand diagram
  • Informed consent to participate

Exclusion Criteria:

  • Pregnancy
  • History of renal disease, diabetes, chemotherapy, tumors, other neurological diseases (e.g., polyneuropathy), thyroid disease
  • Problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout, tendinopathy at the wrist, acute trauma of the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Carpal tunnel syndrome patients
Subjects with unilateral or bilateral carpal tunnel syndrome
Thickness measurement with ultrasound
Healthy
Subjects without carpal tunnel syndrome
Thickness measurement with ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound
Time Frame: baseline
To determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.
baseline
Baseline subsynovial connective tissue thickness
Time Frame: Baseline
To determine correlations between SSCT thickness and participant characteristics (e.g., age, gender) in patients with carpal tunnel syndrome and healthy subjects. To obtain normative data for SSCT thickness in healthy subjects and patients with carpal tunnel syndrome.
Baseline
Change in subsynovial connective tissue thickness after 3, 6 and 12 months
Time Frame: 3, 6, 12 months
To evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).
3, 6, 12 months
Change in subsynovial connective tissue thickness after treatment
Time Frame: 3, 6, 12 months
To evaluate the effect of treatment (i.e., surgery or infiltration) on SSCT thickness in patients with carpal tunnel syndrome. Orthopedic surgeon decides independently if and which treatment is necessary for the patient. If possible, to subgroup patients according to the correlation between their response to treatment, assessed with electrodiagnostic testing and clinical variables, and (change in) SSCT thickness.
3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2020

Primary Completion (Estimated)

May 6, 2024

Study Completion (Estimated)

May 6, 2024

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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