NCT03736252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

November 7, 2018

Last Update Submit

July 29, 2019

Conditions

CMC

Keywords

OrthosisPainFunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Hand osteoarthritis Function

    1 month

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

    1 month

Interventions

Orthosis provisionDEVICE

Hely and Weber CMC controller

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with painful CMC OA

You may qualify if:

  • CMC OA of either thumb with pain

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gannon University

Ruskin, Florida, 33573, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 9, 2018

Study Start

November 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)