- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496398
Median and Ulnar Nerve Function in Tattoo Artists
Occupational Hand-Arm Vibration Exposure and Its Effects on Median and Ulnar Nerve Function in Tattoo Artists: A Case-Control Study
Study Overview
Status
Detailed Description
This observational cross-sectional case-control study evaluates neurosensory and motor function differences between professional tattoo artists exposed to long-term occupational vibration and healthy controls. Chronic exposure to hand-arm vibration (HAV) has been associated with peripheral neuropathy, entrapment neuropathies, and sensory receptor dysfunction.
Participants will undergo standardized assessment including:
Tinel, Phalen, reverse Phalen, and elbow flexion tests
Semmes-Weinstein monofilament testing
Two-point discrimination
Vibration perception testing (30 Hz and 256 Hz)
Grip and pinch strength measurements
Brief Michigan Hand Outcomes Questionnaire
Boston Carpal Tunnel Questionnaire
The study aims to determine whether occupational vibration exposure is associated with measurable alterations in median and ulnar nerve sensory and motor function.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sedanur Güngör, MSc.
- Phone Number: +905334480698
- Email: sedagungor06@hotmail.com
Study Locations
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Ankara, Turkey (Türkiye)
- Recruiting
- Gazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Professional tattoo artists with at least 1 year of occupational experience (case group)
- Healthy individuals without occupational vibration exposure (control group)
- Voluntary participation and provision of informed consent
- No upper extremity trauma or surgery within the last 6 months
Exclusion Criteria:
- Diagnosis of diabetes mellitus
- Diagnosis of peripheral neuropathy
- History of cervical radiculopathy or cervical disc herniation
- History of upper extremity surgery or injury
- Presence of rheumatologic or systemic inflammatory diseases
- Pregnancy
- Substance or alcohol abuse
- Engagement in a second occupation involving repetitive hand use or vibration exposure
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Tattoo Artists (Vibration-Exposed)
Professional tattoo artists aged 18 years and older with at least one year of occupational exposure to hand-arm vibration generated by tattoo machines.
Participants will undergo standardized sensory and motor assessments including nerve provocation tests, Semmes-Weinstein monofilament testing, two-point discrimination, vibration perception threshold, grip and pinch strength measurements, and validated hand function questionnaires.
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Healthy Controls
Age- and sex-matched healthy individuals without occupational vibration exposure and without history of upper extremity trauma, neuropathy, or systemic disease affecting nerve function.
Participants will undergo the same standardized sensory and motor assessments as the case group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Semmes-Weinstein Monofilament Threshold
Time Frame: Baseline (single assessment session)
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Assessment of light touch sensory threshold using Semmes-Weinstein monofilaments applied to the index and little fingers.
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Baseline (single assessment session)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Two-Point Discrimination
Time Frame: Baseline (single assessment session)
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Minimum distance (mm) at which two points are perceived as separate on index and little fingers
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Baseline (single assessment session)
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Vibration Perception Duration
Time Frame: Baseline (single assessment session)
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Duration (seconds) of vibration perception using tuning fork (30 Hz and 256 Hz)
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Baseline (single assessment session)
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Grip Strength
Time Frame: Baseline (single assessment session)
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Maximal hand grip strength measured using a dynamometer (kg)
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Baseline (single assessment session)
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Pinch Strength
Time Frame: Baseline (single assessment session)
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Lateral and tip pinch strength measured using a pinch gauge (kg)
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Baseline (single assessment session)
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Boston Carpal Tunnel Questionnaire Score
Time Frame: Baseline (single assessment session)
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Symptom severity and functional status scores (1-5 scale)
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Baseline (single assessment session)
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Brief Michigan Hand Outcomes Questionnaire Score
Time Frame: Baseline (single assessment session)
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Hand function score normalized to a 0-100 scale
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Baseline (single assessment session)
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Nerve Provocation Test Positivity
Time Frame: Baseline (single assessment session)
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Presence of positive findings in Tinel, Phalen, reverse Phalen, and elbow flexion tests
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Baseline (single assessment session)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Ulnar Neuropathies
- Ulnar Nerve Compression Syndromes
- Carpal Tunnel Syndrome
- Cubital Tunnel Syndrome
Other Study ID Numbers
- 2025-1981
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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