Comparison of Trigger Finger Orthotic Wearing Schedules

NCT04094389 | Completed

• 2 other identifiers: IRB # 1903804IRB_00124056
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• The amount of time in weeks it took to enroll the nine participants.

  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.

  up to 8 months (anticipated)

• The participants' functional use of their hand and comfort while wearing their orthotic.

  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,

  up to 8 months (anticipated)

• The participants' percentage compliance with their prescribed wearing schedules.

  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.

  up to 8 months (anticipated)

• The participants' percentage compliance with their HEP performance schedule

  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.

  up to 8 months (anticipated)

Secondary Outcomes (3)

• Participant outcome measure: Participant pain levels

  up to 8 months (anticipated)

• 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)

Study Arms (3)

Orthotic continuous wear group

EXPERIMENTAL

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.

Other: Orthotic continuous wear group

Orthotic wear during waking hours only group

EXPERIMENTAL

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.

Other: Orthotic wear during waking hours only group

Orthotic wear only while sleeping group

EXPERIMENTAL

In the night-wear group, participants will be told to wear their orthosis only at night.

Other: Orthotic wear only while sleeping group

Interventions

Orthotic continuous wear group OTHER

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.

Orthotic continuous wear group

Orthotic wear during waking hours only group OTHER

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.

Orthotic wear during waking hours only group

Orthotic wear only while sleeping group OTHER

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

Orthotic wear only while sleeping group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• (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.
• (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.

Sponsors & Collaborators

• Sharp HealthCare: lead
• University of Utah: collaborator

Study Sites (1)

Sharp Chula Vista Medical Center Outpatient Rehabilitation Department

Chula Vista, California, 91911, United States

Location

Related Publications (21)

• Adams JE, Habbu R. Tendinopathies of the Hand and Wrist. J Am Acad Orthop Surg. 2015 Dec;23(12):741-50. doi: 10.5435/JAAOS-D-14-00216. Epub 2015 Oct 28.

  PMID: 26510626 BACKGROUND

• Akhtar S, Bradley MJ, Quinton DN, Burke FD. Management and referral for trigger finger/thumb. BMJ. 2005 Jul 2;331(7507):30-3. doi: 10.1136/bmj.331.7507.30. No abstract available.

  PMID: 15994689 BACKGROUND

• Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.

  PMID: 15866967 BACKGROUND

• Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.

  PMID: 19006759 BACKGROUND

• Evans, R., Hunter, J., & Burkhalter, W. (1988). Conservative management of the trigger finger: A new approach. Journal of Hand Therapy, 59-68.

  BACKGROUND

• Drijkoningen T, van Berckel M, Becker SJE, Ring DC, Mudgal CS. Night Splinting for Idiopathic Trigger Digits. Hand (N Y). 2018 Sep;13(5):558-562. doi: 10.1177/1558944717725374. Epub 2017 Aug 20.

  PMID: 28825334 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Froimson, A. (1999). Tenosynovitis and tennis elbow. In: Green, D.P., et al. (eds.), Green's Operative Hand Surgery, wyd. 4. Churchill Livingstone.

  BACKGROUND

• Huisstede BM, van Middelkoop M, Randsdorp MS, Glerum S, Koes BW. Effectiveness of interventions of specific complaints of the arm, neck, and/or shoulder: 3 musculoskeletal disorders of the hand. An update. Arch Phys Med Rehabil. 2010 Feb;91(2):298-314. doi: 10.1016/j.apmr.2009.09.023.

  PMID: 20159137 BACKGROUND

• Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  PMID: 3785962 BACKGROUND

• Kim SJ, Lee CH, Choi WS, Lee BG, Kim JH, Lee KH. The thickness of the A2 pulley and the flexor tendon are related to the severity of trigger finger: results of a prospective study using high-resolution ultrasonography. J Hand Surg Eur Vol. 2016 Feb;41(2):204-11. doi: 10.1177/1753193415615076. Epub 2015 Nov 14.

  PMID: 26568540 BACKGROUND

• Lieberman D, Scheer J. AOTA's Evidence-Based Literature Review Project: an overview. Am J Occup Ther. 2002 May-Jun;56(3):344-9. doi: 10.5014/ajot.56.3.344. No abstract available.

  PMID: 12058525 BACKGROUND

• Makkouk AH, Oetgen ME, Swigart CR, Dodds SD. Trigger finger: etiology, evaluation, and treatment. Curr Rev Musculoskelet Med. 2008 Jun;1(2):92-6. doi: 10.1007/s12178-007-9012-1.

  PMID: 19468879 BACKGROUND

• Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or operate. J Hand Surg Am. 1992 Jan;17(1):110-3. doi: 10.1016/0363-5023(92)90124-8.

  PMID: 1538090 BACKGROUND

• Rodgers JA, McCarthy JA, Tiedeman JJ. Functional distal interphalangeal joint splinting for trigger finger in laborers: a review and cadaver investigation. Orthopedics. 1998 Mar;21(3):305-9; discussion 309-10. doi: 10.3928/0147-7447-19980301-13.

  PMID: 9547815 BACKGROUND

• Ryzewicz M, Wolf JM. Trigger digits: principles, management, and complications. J Hand Surg Am. 2006 Jan;31(1):135-46. doi: 10.1016/j.jhsa.2005.10.013.

  PMID: 16443118 BACKGROUND

• Sato J, Ishii Y, Noguchi H, Takeda M. Sonographic appearance of the flexor tendon, volar plate, and A1 pulley with respect to the severity of trigger finger. J Hand Surg Am. 2012 Oct;37(10):2012-20. doi: 10.1016/j.jhsa.2012.06.027. Epub 2012 Aug 31.

  PMID: 22939830 BACKGROUND

• Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20.

  PMID: 22189188 BACKGROUND

• Valdes K. A retrospective review to determine the long-term efficacy of orthotic devices for trigger finger. J Hand Ther. 2012 Jan-Mar;25(1):89-95; quiz 96. doi: 10.1016/j.jht.2011.09.005.

  PMID: 22265444 BACKGROUND

• Yang TH, Chen HC, Liu YC, Shih HH, Kuo LC, Cha S, Yang HB, Yang DS, Jou IM, Sun YN, Su FC. Clinical and pathological correlates of severity classifications in trigger fingers based on computer-aided image analysis. Biomed Eng Online. 2014 Jul 23;13:100. doi: 10.1186/1475-925X-13-100.

  PMID: 25055721 BACKGROUND

• Young IA, Cleland JA, Michener LA, Brown C. Reliability, construct validity, and responsiveness of the neck disability index, patient-specific functional scale, and numeric pain rating scale in patients with cervical radiculopathy. Am J Phys Med Rehabil. 2010 Oct;89(10):831-9. doi: 10.1097/PHM.0b013e3181ec98e6.

  PMID: 20657263 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• John C Avery, BS

  Sharp Chula Vista Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist, Certified Hand Therapist

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 18, 2019
• Study Start: September 20, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)