- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491058
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
Conditions
Intervention / Treatment
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
- Name: Elise Robben, MD
- Phone Number: +3216338700
- Email: elise.robben@kuleuven.be
Study Locations
-
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgium, 3000
- UZ Leuven
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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
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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
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- S63134
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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