NCT07496398

Brief Summary

This case-control study aims to investigate the effects of occupational hand-arm vibration exposure on median and ulnar nerve functions in tattoo artists. Chronic exposure to vibration generated by tattoo machines may lead to neurosensory impairment, reduced tactile sensitivity, and decreased hand strength. Objective assessments including nerve provocation tests, sensory threshold evaluation, two-point discrimination, vibration perception, grip and pinch strength measurements, and validated patient-reported outcome questionnaires will be used. Findings will be compared with age- and sex-matched healthy controls.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 27, 2026

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

March 19, 2026

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Semmes-Weinstein Monofilament Threshold

    Assessment of light touch sensory threshold using Semmes-Weinstein monofilaments applied to the index and little fingers.

    Baseline (single assessment session)

Secondary Outcomes (7)

  • Two-Point Discrimination

    Baseline (single assessment session)

  • Vibration Perception Duration

    Baseline (single assessment session)

  • Grip Strength

    Baseline (single assessment session)

  • Pinch Strength

    Baseline (single assessment session)

  • Boston Carpal Tunnel Questionnaire Score

    Baseline (single assessment session)

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Professional tattoo artists with at least one year of occupational exposure to vibration and age- and sex-matched healthy individuals.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel SyndromeCubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesUlnar NeuropathiesUlnar Nerve Compression Syndromes

Central Study Contacts

Sedanur Güngör, MSc.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 27, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 27, 2026

Record last verified: 2025-11

Locations