NCT03294733

Brief Summary

Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

2.7 years

First QC Date

September 19, 2017

Last Update Submit

February 24, 2020

Conditions

Carpal Tunnel

Outcome Measures

Primary Outcomes (1)

  • Size of carpal tunnel

    using ultrasound imaging to determine size of carpal tunnel

    Baseline

Study Arms (1)

Ultrasound

OTHER

Ultrasound wrists to determine carpal tunnel size

Procedure: Ultrasound

Interventions

UltrasoundPROCEDURE

This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer

Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than age 18 having bilateral wrists amenable to ultrasound examination.

You may not qualify if:

  • Active carpal tunnel syndrome,
  • history of carpal tunnel syndrome
  • any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist)
  • distal radius fracture deformity
  • rheumatoid arthritis
  • open wounds or lesions of the hand or forearm
  • known congenital deformities of the upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Median Neuropathy

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Peter M Murray

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: ultrasound carpal tunnel size on subjects
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Orthopedic Department Mayo Clinic Florida

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 27, 2017

Study Start

May 22, 2017

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)