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Effectiveness of a Neoprene CMC Joint Orthosis

NCT ID: NCT03736252

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-05-01

Brief Summary

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Patients will be gathered via convenience sample from a hand therapy clinic. They will be provided with a neoprene commercially available orthosis free of charge. Baseline pain and function will be assessed using the VAS and Functional Index of Hand Arthropathies. Four weeks later, pain, function, and patient satisfaction with the device will be gathered using the Quebec User Evaluation of Assistive Technology questionnaire.

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Detailed Description

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Patients with the diagnosis of carpometacarpal osteoarthritis that are receiving hand therapy will be recruited for the study. Baseline measurements will include usual pain over the past week, current pain, and worst pain experienced over the past week using the VAS pain scale. Hand function will be assessed using the Functional Index of Hand Arthropathies measure. The patients will be provided with a free neoprene hand orthosis (Hely and Weber CMC controller). They will be instructed to wear the device as needed for pain. After 1 month, the investigators will call the patient to assess pain, function, and satisfaction with the device using the Quebec User Evaluation of Assistive Technology Questionnaire.

Conditions

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CMC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Orthosis provision

Hely and Weber CMC controller

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* CMC OA of either thumb with pain

Exclusion Criteria

* CMC arthroplasty
* recent surgery
* dementia
* no pain at CMC joint
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gannon University

OTHER

Sponsor Role lead

Responsible Party

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Kristin Valdes

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gannon University

Ruskin, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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GUIRB-2018-8-66

Identifier Type: -

Identifier Source: org_study_id

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