Serum GDF-15 in Carpal Tunnel Syndrome

Evaluation of the Association of Serum Growth Differentiation Factor-15 Levels With Clinical Findings and Electrophysiological Severity in Patients With Carpal Tunnel Syndrome

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07791316

Enrollment

Registered

2026-08-27

Start date

2026-08-30

Completion date

2026-11-15

Last updated

2026-08-27

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

Conditions

Carpal Tunnel Syndrome

Brief summary

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.

Detailed description

This is a single-center observational study including patients with idiopathic carpal tunnel syndrome and asymptomatic controls. Serum GDF-15 levels will be evaluated and their associations with clinical and electrophysiological characteristics will be assessed.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* Diabetes mellitus. * Hypothyroidism. * Rheumatoid arthritis or other inflammatory rheumatic diseases. * Pregnancy. * Cervical radiculopathy or polyneuropathy. * Previous carpal tunnel or wrist surgery. * History of wrist trauma or fracture. * Corticosteroid injection into the carpal tunnel within the previous 3 months. * Malignancy. * Chronic kidney or liver disease. * Active infection or autoimmune disease. * Serious systemic conditions that may affect serum GDF-15 levels.

Design outcomes

Primary

Measure	Time frame	Description
Serum Growth Differentiation Factor-15 (GDF-15) Concentration	At baseline	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).

Secondary

Measure	Time frame	Description
Correlation Between Serum GDF-15 Concentration and Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score	At baseline	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.
Correlation Between Serum GDF-15 Concentration and Boston Carpal Tunnel Questionnaire Functional Status Scale Score	At baseline	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.
Correlation of Serum GDF-15 With Hand Grip Strength	At baseline	Correlation between serum GDF-15 (pg/mL) and hand grip strength measured in kilograms (kg) using a Jamar hand dynamometer.
Serum GDF-15 Concentration According to Electrophysiological Severity of Carpal Tunnel Syndrome	At baseline	Serum GDF-15 concentration (pg/mL) will be compared among mild, moderate, and severe carpal tunnel syndrome groups classified by nerve conduction studies.
Correlation of Serum GDF-15 With Pain Severity	At baseline	Correlation between serum GDF-15 concentration (pg/mL) and pain severity assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity.
Correlation of Serum GDF-15 With Numbness Severity	At baseline	Correlation between serum GDF-15 concentration (pg/mL) and numbness severity assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no numbness and 10 indicates the worst imaginable numbness. Higher scores indicate greater numbness severity.

Outcome results