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Not yet recruitingNCT07791316Updated Aug 27, 2026

Serum GDF-15 in Carpal Tunnel Syndrome

An observational study in Carpal Tunnel Syndrome, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Carpal Tunnel Syndrome
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In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's planned enrollment of 60 is below the median of 92 across 131 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-65 years.
  • Written .
  • 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

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.
  • injection into the carpal tunnel within the previous 3 months.
  • .
  • Chronic kidney or liver disease.
  • Active infection or disease.
  • Serious systemic conditions that may affect serum GDF-15 levels.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

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

  5. 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.

    Time frame: At baseline

  6. 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.

    Time frame: At baseline

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Nov 2026, 2 months later.

Of 38 non-industry observational studies under Carpal Tunnel Syndrome, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 2 months is below that.

Counting every sponsor, half of 40 studies reached it within 13 months; a quarter within 8 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 27, 2026
StartEst.
Aug 30, 2026
Primary completionEst.
Nov 1, 2026
CompletionEst.
Nov 15, 2026
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07791316
Responsible party
Zeynep Karakuzu Güngör (Physical Medicine and Rehabilitation Specialist, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Aug 27, 2026
Start date
Aug 30, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Aug 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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