Effectiveness of a Neoprene CMC Joint Orthosis

Completed

• Conditions: CMC

• Registration Number: NCT03736252
• Lead Sponsor: Gannon University

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• CMC OA of either thumb with pain

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain using the Visual Analog Scale (VAS) scale	1 month	Pain measured with VAS pain scale, measured from 1-10. 1 is the best and 10 is the worst

Secondary Outcome Measures

Name	Time	Method
Hand osteoarthritis Function	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.
Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology	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

Trial Locations

Locations (1)

Gannon University; 🇺🇸 Ruskin, Florida, United States