NCT06539871

Brief Summary

The Role of Ultrasonography in Detecting Additional Peripheral Nerve Injuries Overshadowed by Clinical and Electrodiagnostic Data in Patients with Peripheral Nerve Injury After the February 6, 2023 Earthquake

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

July 31, 2024

Last Update Submit

August 4, 2024

Conditions

Keywords

Double Crush Syndrome6, February 2023 EarhquakePeripheral Nerve InjuriesElectroneuromyographyUltrasonography

Outcome Measures

Primary Outcomes (2)

  • Ultrasonographic measurements

    For patients with nerve damage in the upper extremities, ultrasonographic examination of the median, ulnar and radial nerves from both upper extremities was performed. Median, ulnar and radial nerves were examined from the wrist level to the axilla. Diameter measurements were made from various points and recorded. For patients with nerve damage in the lower extremity, ultrasonographic examination of the sciatic, peroneal and tibial nerves was performed. Sciatic, peroneal and tibial nerves were examined from the ankle level to the gluteal fold level. Diameter measurements were made from various points and recorded.

    Ultrasonography examination was performed in 4 patients at the end of the 1st month after the earthquake, in 6 patients at the 3rd month, and in 5 patients at the 6th month.

  • Electroneuromyographic data

    All patients were examined electrophysiologically. Relevant data and electrophysiological diagnoses were recorded.

    ENMG examination was performed in 4 patients at the end of the 1st month after the earthquake, in 6 patients at the 3rd month, and in 5 patients at the 6th month.

Other Outcomes (1)

  • Information obtained from the patient

    This information was obtained at the time of initial presentation in all patients.

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients included in the study were rescued from under the rubble. Peripheral nerve damage was considered in all patients and they were referred to us. Patients who were not considered to have peripheral nerve damage after physical examination and electrophysiological examinations were not included in the study.

You may qualify if:

  • Being between the ages of 12-65
  • Being buried under rubble in an earthquake
  • Patients with suspected peripheral nerve damage and/or plexus damage after history and physical examination
  • Volunteering to participate in the study and signing a consent form

You may not qualify if:

  • Hemodynamic instability
  • Presence of a medical condition that is a contraindication to EMG
  • Contact isolation
  • Open wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Ilker Yagci

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 6, 2024

Study Start

October 1, 2023

Primary Completion

December 1, 2023

Study Completion

September 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations