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NCT Number: NCT07791316

Serum GDF-15 in Carpal Tunnel Syndrome

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Correlation of Serum GDF-15 With Hand Grip Strength

    Time frame: At baseline

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

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

    Time frame: 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.

  5. Correlation of Serum GDF-15 With Pain Severity

    Time frame: 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.

  6. Correlation of Serum GDF-15 With Numbness Severity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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