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OpenTrials
Completed

NCT Number: NCT03736252

Effectiveness of a Neoprene CMC Joint Orthosis

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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Key information

Conditions

CMC Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gannon University

Ruskin, Florida, 33573, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CMC OA of either thumb with pain

Exclusion criteria

  • CMC arthroplasty
  • recent surgery
  • dementia
  • no pain at CMC joint

Treatment and study plan

Orthosis provision

Device

Hely and Weber CMC controller

Primary outcomes

  1. Pain using the Visual Analog Scale (VAS) scale

    Time frame: 1 month

    Pain measured with VAS pain scale, measured from 1-10. 1 is the best and 10 is the worst

Secondary outcomes

  1. Hand osteoarthritis Function

    Time frame: 1 month

    Function measured with FIHOA.The FIHOA assesses hand OA-related functional impairment scoring from 0 (no functional impairment) to 30 points (maximal impairment).The total score ranges from 0 to 30, with a validated threshold of 5 able to distinguish between symptomatic and not symptomatic patients or controls.

  2. Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology

    Time frame: 1 month

    Measured with QUEST scale. The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components, Device and Services. Scores of 1 indicate dissatisfaction and scores of 5 indicate high satisfaction

Sponsors and collaborators

Lead sponsor

Gannon University

Other

Registry information

Official study title

Effectiveness of a Neoprene CMC Joint Orthosis for Pain, Function, and Patient Satisfaction

Acronym: Carpometacar

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2018
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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