Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
146 participants
INTERVENTIONAL
2023-08-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis
The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.
Oval-8 ® Orthosis
The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.
Control Group-No Orthosis
The control group will be identical to the experimental group except without the use of a nighttime orthosis. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.
Cortisone injection only
The control group will receive a cortisone injection and be instructed to move their fingers normally
Interventions
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Oval-8 ® Orthosis
The experimental group will consist of receiving a PIP joint on the day they receive their cortisone injection. The Oval-8 ® will be issued to the subject by an Occupational Therapist to ensure correct fit and comfort as well as given written instructions for night use. The orthosis will be worn at night for 6-week duration. Participants will have 1 follow up phone call or email at the 6-week mark and then 1 follow up phone call or email at the 12 week mark by a member of the research team from the time they received their cortisone injection where the time for resolution of trigger finger symptoms, VAS (Visual Analogue Scale), subjective questionnaire and QuickDASH scores will all be recorded in their medical research file.
Cortisone injection only
The control group will receive a cortisone injection and be instructed to move their fingers normally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with trigger finger, aka stenosing flexor tenosynovitis
* Status post receiving cortisone injection of the affected digit(s)
Exclusion Criteria
* Patients with rheumatoid arthritis
* Patients with a history of traumatic injury to the hand
* Cognitive or behavioral problems which would preclude informed consent
* Unable to speak and understand English
18 Years
100 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Pamela Roberts
Executive Director
Locations
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Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Pamela Roberts, PhD
Role: primary
Other Identifiers
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00002410
Identifier Type: -
Identifier Source: org_study_id
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