Serum GDF-15 in Carpal Tunnel Syndrome

NCT07791316 | Not Yet Recruiting

• 1 other identifier: KTS-GDF15-2026-01
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

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).

  At baseline

Secondary Outcomes (6)

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

  At baseline

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

  At baseline

• Correlation of Serum GDF-15 With Hand Grip Strength

  At baseline

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

  At baseline

• Correlation of Serum GDF-15 With Pain Severity

  At baseline

Study Arms (2)

Carpal Tunnel Syndrome Group

Patients with idiopathic carpal tunnel syndrome confirmed by clinical and electrophysiological evaluation.

Control Group

Asymptomatic participants without clinical signs or symptoms of carpal tunnel syndrome.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples collected from participants for measurement of GDF-15 levels.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 27, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share