Comparison of Trigger Finger Orthotic Wearing Schedules

Completed · Not applicable

Conditions studied: Trigger Finger

In brief

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?

Key facts

Study ID

NCT04094389

Run by

Sharp HealthCare

People needed

9

Starts

2019-09-20

Expected to finish

2020-05-01

Last updated by the study team

2020-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• referred to hand therapy with single digit triggering of left and / or right hand.
• agreement to participate in the study and receive an orthotic as part of the treatment of digital triggering.
• If after four months of utilizing the previously stated criteria all nine participants have not been able to be recruited, the criteria will be broadened. The inclusion criteria will be broadened to include:
• (1) referred for hand therapy with one or more digits triggering.

You may not qualify if…

• a triggering digit that presents with Froimson's (1999) grade III or IV of severity (Table 1).
• triggering of the affected digit for greater than 6 months.
• more than one triggering digit per hand.
• a triggering thumb.
• have received a corticosteroid injection in the triggering digit within the past 2 years.
• do not speak English.
• a diagnosed cognitive deficit that impairs their ability to follow the protocol of the study and provide informed consent to participate in the study.
• less than 18 years of age.
• If after four months of utilizing the previously stated criteria all nine participants have not been able to be recruited, the criteria will be broadened. The exclusion criteria will be broadened to include:
• (1) a triggering digit that is locked in flexion and unable to be passively unlocked; Froimson's (1999) grade IV.
• Table 1 Froimson's (1999) grading of digital triggering severity
• Grade I: Pain associated with pre-triggering. Tenderness to palpation over the first annular pulley. Reported history of digital triggering, although not reproducible during clinical examination.
• Grade II: Digital triggering occurs, although, digit can be unlocked with active extension.
• Grade III: Digital triggering occurs and passive extension is necessary to unlock the digit, or active flexion is unable to be performed at the digit.
• Grade IV: Digital triggering of the interphalangeal joint is unable to be unlocked with active or passive movement.

Where it is running

• Sharp Chula Vista Medical Center Outpatient Rehabilitation Department — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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