Serum GDF-15 in Carpal Tunnel Syndrome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

This observational study aims to evaluate serum Growth Differentiation Factor-15 (GDF-15) levels in patients with idiopathic carpal tunnel syndrome compared with asymptomatic controls. The study will also assess the associations between serum GDF-15 levels and clinical and electrophysiological characteristics of carpal tunnel syndrome.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-65 years.

Written informed consent.

For the patient group: idiopathic carpal tunnel syndrome confirmed by clinical and electrophysiological evaluation.

For the control group: asymptomatic individuals without a previous diagnosis of carpal tunnel syndrome and without clinical signs of carpal tunnel syndrome.

Disqualifiers

Diabetes mellitus.

Hypothyroidism.

Rheumatoid arthritis or other inflammatory rheumatic diseases.

Pregnancy.

Trial population

Adults aged 18-65 years, including patients with clinically and electrophysiologically confirmed idiopathic carpal tunnel syndrome and asymptomatic controls.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Carpal Tunnel Syndrome Group
Group B: Control Group

Trial outcomes

Primary outcomes

1

Serum Growth Differentiation Factor-15 (GDF-15) Concentration

Serum Growth Differentiation Factor-15 (GDF-15) concentration will be quantitatively measured from serum samples using a sandwich enzyme-linked immunosorbent assay (ELISA). GDF-15 concentration will be reported in picograms per milliliter (pg/mL).

Time frame
At baseline

Secondary outcomes

1

Correlation Between Serum GDF-15 Concentration and Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score

The correlation between serum Growth Differentiation Factor-15 (GDF-15) concentration, measured in pg/mL using ELISA, and symptom severity will be assessed using the Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire (BCTQ). The Symptom Severity Scale consists of 11 items scored from 1 to 5, with a final score ranging from 1 to 5. Higher scores indicate greater symptom severity.

Time frame
At baseline
2

Correlation Between Serum GDF-15 Concentration and Boston Carpal Tunnel Questionnaire Functional Status Scale Score

The correlation between serum Growth Differentiation Factor-15 (GDF-15) concentration, measured in pg/mL using ELISA, and functional status will be assessed using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ). The Functional Status Scale consists of 8 items scored from 1 to 5, with a final score ranging from 1 to 5. Higher scores indicate greater functional impairment.

Time frame
At baseline
3

Correlation of Serum GDF-15 With Hand Grip Strength

Correlation between serum GDF-15 (pg/mL) and hand grip strength measured in kilograms (kg) using a Jamar hand dynamometer.

Time frame
At baseline
4

Serum GDF-15 Concentration According to Electrophysiological Severity of Carpal Tunnel Syndrome

Serum GDF-15 concentration (pg/mL) will be compared among mild, moderate, and severe carpal tunnel syndrome groups classified by nerve conduction studies.

Time frame
At baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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