Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: SSCT thickness measurement

• Registration Number: NCT04491058
• Lead Sponsor: KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-29
• Study Start: 2020-08-11
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	SSCT thickness measurement	Subjects without carpal tunnel syndrome
Carpal tunnel syndrome patients	SSCT thickness measurement	Subjects with unilateral or bilateral carpal tunnel syndrome

Primary Outcome Measures

Name	Time	Method
Baseline subsynovial connective tissue thickness	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.
Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound	baseline	To determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.
Change in subsynovial connective tissue thickness after treatment	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.
Change in subsynovial connective tissue thickness after 3, 6 and 12 months	3, 6, 12 months	To evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium