Carpal Tunnel SyndromeNCT07791316
Serum GDF-15 in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18-65 years, including patients with clinically and electrophysiologically confirmed idiopathic carpal tunnel syndrome and asymptomatic controls.
Who may be able to join
- 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.
Who cannot join
- Diabetes mellitus.
- Hypothyroidism.
- Rheumatoid arthritis or other inflammatory rheumatic diseases.
- Pregnancy.
- Cervical radiculopathy or polyneuropathy.
- Previous carpal tunnel or wrist surgery.
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- 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.
About this study
Official title: Evaluation of the Association of Serum Growth Differentiation Factor-15 Levels With Clinical Findings and Electrophysiological Severity in Patients With 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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline
Secondary outcomes (6)
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.
Measured: At baseline
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.
Measured: At baseline
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.
Measured: At baseline
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.
Measured: At baseline
Correlation of Serum GDF-15 With Pain Severity
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.
Measured: At baseline
Correlation of Serum GDF-15 With Numbness Severity
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Karakuzu Güngör, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791316
- Sponsor's protocol ID
- KTS-GDF15-2026-01
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association of Serum Growth Differentiation Factor-15 Levels With Clinical Findings and Electrophysiological Severity in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07791316
- Acronym / sponsor ID
- KTS-GDF15-2026-01
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-65 years, including patients with clinically and electrophysiologically confirmed idiopathic carpal tunnel syndrome and asymptomatic controls.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Diabetes mellitus.
- Hypothyroidism.
- Rheumatoid arthritis or other inflammatory rheumatic diseases.
- Pregnancy.
- Cervical radiculopathy or polyneuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
6 secondary outcomes
Correlation Between Serum GDF-15 Concentration and Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Time frame: At baseline
Correlation Between Serum GDF-15 Concentration and Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Time frame: At baseline
Correlation of Serum GDF-15 With Hand Grip Strength
Time frame: At baseline
Serum GDF-15 Concentration According to Electrophysiological Severity of Carpal Tunnel Syndrome
Time frame: At baseline
Correlation of Serum GDF-15 With Pain Severity
Time frame: At baseline
Correlation of Serum GDF-15 With Numbness Severity
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Kanuni Sultan Suleyman Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Growth Differentiation Factor-15 (GDF-15) Concentration (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.