Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Diagnostic Test: SSCT thickness measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carpal tunnel syndrome patients<br> | Diagnostic Test: SSCT thickness measurement<br>* Thickness measurement with ultrasound<br>|
| Healthy<br> | Diagnostic Test: SSCT thickness measurement<br>* Thickness measurement with ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal Tunnel Syndrome, Subsynovial Connective Tissue, Ultrasound