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This study is to analyze the effectiveness of a nighttime extension orthosis after receiving a cortisone injection for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.
The purpose of the research is to analyze the effectiveness of a proximal interphalangeal joint (PIPJ) extension night orthosis status-post cortisone injection of the first annular pulley for the treatment of trigger finger to improve pain and restore functional outcomes. The investigators hypothesize that the extension orthosis will improve pain and functional outcomes (Quick Dash score) compared to those without a digital night extension orthosis in those with trigger finger at 12 weeks from the injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis | Experimental | 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. |
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| Control Group-No Orthosis | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oval-8 ® Orthosis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Trigger Finger Symptoms | Questionnaire used to determine resolution of Trigger Finger Symptoms | 6 Weeks |
| Resolution of Trigger Finger Symptoms | Questionnaire used to determine resolution of Trigger Finger Symptoms | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain | Visual Analogue Scale for Pain (0 pain free to 10 severe pain) | 6 weeks |
| Change in Pain | Visual Analogue Scale for Pain (0 pain free to 10 severe pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theodore Brown, BS | Contact | 800-700-6424 | Theodore.Brown@cshs.org | |
| Meghan McCullough, MD | Contact | Meghan.McCullough@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Meghan McCullough, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic | Completed | Los Angeles | California | 90048 | United States |
Individual participant data will not be available for sharing.
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| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| D052582 | Trigger Finger Disorder |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
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The primary objective of this study is to analyze the effectiveness of a nighttime PIP joint extension orthosis to improve pain and restore functional outcomes in TF and comparing two groups of participants with TF, one group receiving a cortisone injection only and the experimental group receiving the nighttime orthosis after cortisone injection using the QuickDASH.
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No masking
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| Cortisone injection only | Other | The control group will receive a cortisone injection and be instructed to move their fingers normally |
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| 12 weeks |
| Change in Perception of Function | QuickDash scores (0% no functional limitations to 100% disabled) | 12 weeks |
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
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| D009140 |
| Musculoskeletal Diseases |