Comparison of Trigger Finger Orthotic Wearing Schedules: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The amount of time in weeks it took to enroll the nine participants.
研究概览
简要总结
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?
详细描述
Participants:
Nine participants will be recruited through a convenience sampling of patients as they become available through referral by physicians, physician assistants, and nurse practioners to the researcher's clinic for hand therapy, meet the study's eligibility criteria and provide informed consent to participate in the study. Medical records review will be performed by the principal investigator who will also be the potential participants' treating therapist.
At the onset of the study and as new referral sources become available, until all nine participants required for the study are enrolled, project flyers will be provided to referring physicians, physician assistants and nurse practioners for posting in their offices and providing to interested potential participants as desired.
Number of participants to be included and/or enrolled in this entire study, across all study locations: 20 Nine participants are needed for data analysis, however, 20 participants have been indicated for enrollment to cover for anticipated participant withdrawals and those who are lost to follow-up.
Age of Subjects: 18 to 85+ Vulnerable participant groups included: None Gender of Subjects: There are no gender-based enrollment restrictions for this study. Within the limitations imposed by the population of people with trigger finger, it is intended that there will be an equal gender distribution of the subjects included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The amount of time in weeks it took to enroll the nine participants.
时间窗: up to 8 months (anticipated)
To assist with determining the feasibility of the study, the rate at which participants become available for the study will be measured, analyzed and reported through descriptive statistics.
The participants' percentage compliance with their prescribed wearing schedules.
时间窗: up to 8 months (anticipated)
To permit measuring the participants' compliance with their prescribed HEP performance schedule, the participants will be asked to complete a daily check-box log. To assist with determining the feasibility of the study, the participants' percentage compliance with their prescribed wearing schedules will be analyzed and reported through descriptive statistics.
The participants' percentage compliance with their HEP performance schedule
时间窗: up to 8 months (anticipated)
To permit measuring the participants' compliance with their prescribed HEP performance schedule, the participants will be asked to complete a daily check-box log. To assist with determining the feasibility of the study, The participants' percentage compliance with their HEP performance schedule will be analyzed and reported through descriptive statistics.
The participants' functional use of their hand and comfort while wearing their orthotic.
时间窗: up to 8 months (anticipated)
To permit measuring the comfort of the orthotic and the participants functional use of their hand while wearing the orthotic, the participants will be asked to complete a daily log. The participants' functional use of their hand and comfort while wearing their orthotic will be included in the data analysis and reported through descriptive statistics to assist with determining the feasibility of the study,
次要结局
- Participant outcome measure: Participant trigger finger severity(up to 8 months (anticipated))
- Participant outcome measure: QuickDASH for the measurement of upper extremity symptoms and disability(up to 8 months (anticipated))
- Participant outcome measure: Participant pain levels(up to 8 months (anticipated))
研究者
John Avery, OTR/L, CHT
Occupational Therapist, Certified Hand Therapist
Sharp HealthCare