NCT04094389

Comparison of Trigger Finger Orthotic Wearing Schedules

Comparison of Trigger Finger Orthotic Wearing Schedules: A Feasibility Study
Sharp HealthCare·ClinicalTrials.gov·otherCompleted
View on ClinicalTrials.gov
Study focus
Disease/Condition
Trigger Finger
Drug/Device/Intervention
Orthotic continuous wear group
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Sharp HealthCare
Location
Chula Vista, United States of America
Timeline & enrollment
Phase
N/A
Start date
Sep 20, 2019
End date
May 01, 2020
Enrollment
9 participants
Primary outcome

The amount of time in weeks it took to enroll the nine participants.,The participants' functional use of their hand and comfort while wearing their orthotic.,The participants' percentage compliance with their prescribed wearing schedules.,The participants' percentage compliance with their HEP performance schedule

Summary

A randomized prospective pre-post test case series was chosen for this study. This case
 series will provide feasibility data in preparation for a randomized controlled study of this
 topic in the future.
 
 The primary research question for this case series is as follows: Do the three proposed
 orthotic wearing schedules provide varying results in the reduction of digital triggering
 severity and level of pain experienced by those with trigger finger? The following three
 orthotic wearing schedules will be investigated: only during waking hours, only while
 sleeping, and continuously.
 
 To examine the feasibility of the study the following questions are posed:
 
 What was the length of time required to recruit nine eligible participants for the case
 series through the outpatient clinic utilized for this feasibility study? Based upon the rate
 of recruitment for the feasibility study, were the initial methods of recruitment adequate or
 did additional strategies need to be implemented to recruit a sufficient number of
 participants within the desired time frame? Were the orthotics utilized for the study
 comfortable to wear and functional for the participants while performing their activities of
 daily living? Were the number and type of adverse events including redness, edema, tingling,
 or numbness associated with orthotic wear similar across the groups, limited, non-serious,
 and did not interfere with orthotic wearing? Did participants wear their orthotics for the
 prescribed wearing schedule?

ICD-10 classifications
Trigger fingerAccessory finger(s)Fused fingersAccessory thumb(s)Clubbing of fingers
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04094389
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04094389 through Pure Global AI's free database. This phase not specified trial is sponsored by Sharp HealthCare and is currently Completed. The study focuses on Trigger Finger. Target enrollment is 9 participants.

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