Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04491058
• Other study ID #: S63134
• Status: Active, not recruiting
• Start date: August 11, 2020
• Est. completion date: May 6, 2024

Study information

• Verified date: February 2024
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 92
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• SSCT thickness measurement
Thickness measurement with ultrasound

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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