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Effectiveness of a Neoprene CMC Joint Orthosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03736252
Acronym
Carpometacar
Enrollment
75
Registered
2018-11-09
Start date
2018-11-01
Completion date
2019-05-01
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMC

Keywords

Orthosis, Pain, Function

Brief summary

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.

Detailed description

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.

Interventions

DEVICEOrthosis provision

Hely and Weber CMC controller

Sponsors

Gannon University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* CMC OA of either thumb with pain

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Pain using the Visual Analog Scale (VAS) scale1 monthPain measured with VAS pain scale, measured from 1-10. 1 is the best and 10 is the worst

Secondary

MeasureTime frameDescription
Hand osteoarthritis Function1 monthFunction 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.
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology1 monthMeasured 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026