Effectiveness of a Neoprene CMC Joint Orthosis

CMC Clinical Trial

— Carpometacar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03736252
• Other study ID #: GUIRB-2018-8-66
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: Gannon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CMC OA of either thumb with pain

Exclusion Criteria:

• CMC arthroplasty

• recent surgery

• dementia

• no pain at CMC joint

Related Conditions & MeSH terms

• CMC

Intervention

Device:
• Orthosis provision
Hely and Weber CMC controller

Locations

Country	Name	City	State
United States	Gannon University	Ruskin	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gannon University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain using the Visual Analog Scale (VAS) scale	Pain measured with VAS pain scale, measured from 1-10. 1 is the best and 10 is the worst	1 month
Secondary	Hand osteoarthritis Function	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.	1 month
Secondary	Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology	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	1 month