Comparison of Trigger Finger Orthotic Wearing Schedules

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?

Conditions

• Trigger Finger

Interventions

OTHER

Orthotic continuous wear group

Performed exclusively for research purposes, participants will be assigned at entrance to the study to either wear the orthotic continuously, only during waking hours, or only while sleeping. There will be three participants in each of the three groups. Participants in the continuous wear group will be instructed to wear their orthotic continuously around the clock as tolerated with removal for hygiene and home exercise program (HEP) performance. Consistent with standard of care for the treatment of trigger finger with an orthotic, all nine of the participants will be instructed to wear their orthotic for at least six weeks, as tolerated, with continuation of orthotic wear up to 10 weeks if their triggering has not completely abated.

OTHER

Orthotic wear during waking hours only group

Performed exclusively for research purposes, participants will be assigned at entrance to the study to either wear the orthotic continuously, only during waking hours, or only while sleeping. There will be three participants in each of the three groups. Participants in the waking hours only group will be instructed to wear their orthotic during all waking hours as tolerated, with removal for hygiene, HEP performance, but not at night while sleeping. Consistent with standard of care for the treatment of trigger finger with an orthotic, all nine of the participants will be instructed to wear their orthotic for at least six weeks, as tolerated, with continuation of orthotic wear up to 10 weeks if their triggering has not completely abated.

OTHER

Orthotic wear only while sleeping group

Performed exclusively for research purposes, participants will be assigned at entrance to the study to either wear the orthotic continuously, only during waking hours, or only while sleeping. There will be three participants in each of the three groups. In the night-wear group, participants will be told to wear their orthosis only at night. Consistent with standard of care for the treatment of trigger finger with an orthotic, all nine of the participants will be instructed to wear their orthotic for at least six weeks, as tolerated, with continuation of orthotic wear up to 10 weeks if their triggering has not completely abated

Sponsors & Collaborators

• University of Utah

  collaborator OTHER

• Sharp HealthCare

  lead OTHER

Principal Investigators

• John C Avery, BS · Sharp Chula Vista Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-20

Primary Completion

2020-03-30

Completion

2020-05-01

Countries

• United States

Study Locations