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Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491058
Enrollment
92
Registered
2020-07-29
Start date
2020-08-11
Completion date
2024-05-06
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, Subsynovial Connective Tissue, Ultrasound

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.

Interventions

DIAGNOSTIC_TESTSSCT thickness measurement

Thickness measurement with ultrasound

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasoundbaselineTo determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.
Baseline subsynovial connective tissue thicknessBaselineTo 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.
Change in subsynovial connective tissue thickness after 3, 6 and 12 months3, 6, 12 monthsTo evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).
Change in subsynovial connective tissue thickness after treatment3, 6, 12 monthsTo 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026