Hand InjuriesNCT05837286
Conservative Treatment of Trigger Finger
A study testing Oval-8 ® Orthosis and Cortisone injection only in people with Hand Injuries and Trigger Finger, run by Cedars-Sinai Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hand Injuries, Trigger Finger
- What is being tested?
- Oval-8 ® Orthosis and Cortisone injection only
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 18 years old or older are included
- Patients with trigger finger, aka stenosing flexor tenosynovitis
- Status post receiving cortisone injection of the affected digit(s)
Who cannot join
- Any records flagged with break the glass or research opt out
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Meghan McCullough, MD contact
United States2 sites, 1 recruiting
- Completed
Cedars-Sinai Medical Center Outpatient Rehabilitation Hand Clinic
Los Angeles, California, 90048
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Theodore Brown, 310-423-9200, theodore.brown@cshs.org
About this study
Official title: Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Hand Injuries, Trigger Finger
- Being tested
- Oval-8 ® Orthosis, Cortisone injection only
- Medical subject headings
- Hand Injuries, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oval-8 ® OrthosisDevice
Also called Cortisone Injection
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 onlyOther
The control group will receive a cortisone injection and be instructed to move their fingers normally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oval-8 ® Orthosis |
| 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. Receives: Other: Cortisone injection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Trigger Finger Symptoms
Questionnaire used to determine resolution of Trigger Finger Symptoms
Measured: 6 Weeks
Resolution of Trigger Finger Symptoms
Questionnaire used to determine resolution of Trigger Finger Symptoms
Measured: 12 Weeks
Secondary outcomes (3)
Change in Pain
Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
Measured: 6 weeks
Change in Pain
Visual Analogue Scale for Pain (0 pain free to 10 severe pain)
Measured: 12 weeks
Change in Perception of Function
QuickDash scores (0% no functional limitations to 100% disabled)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Aug 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meghan McCullough, MD, Cedars-Sinai Medical Center
- Investigators
- Meghan McCullough, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837286
- Sponsor's protocol ID
- 00002410
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Trigger Finger: Outcomes of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05837286
- Acronym / sponsor ID
- 00002410
- Conditions
- Hand Injuries, Trigger Finger
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis | Experimental | Device: Oval-8 ® OrthosisThe 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 | Active comparator | Other: Cortisone injection onlyThe 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals 18 years old or older are included
- Patients with trigger finger, aka stenosing flexor tenosynovitis
- Status post receiving cortisone injection of the affected digit(s)
Key exclusion criteria (5 listed)
- Any records flagged with break the glass or research opt out
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oval-8 ® OrthosisAlso: Cortisone InjectionThe 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. | Device | Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis |
| Cortisone injection onlyThe control group will receive a cortisone injection and be instructed to move their fingers normally | Other | Control Group-No Orthosis |
Primary outcome
Resolution of Trigger Finger Symptoms
Time frame: 6 Weeks
Questionnaire used to determine resolution of Trigger Finger Symptoms
Resolution of Trigger Finger Symptoms
Time frame: 12 Weeks
Questionnaire used to determine resolution of Trigger Finger Symptoms
3 secondary outcomes
Change in Pain
Time frame: 6 weeks
Change in Pain
Time frame: 12 weeks
Change in Perception of Function
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan McCullough, MD contact
Meghan McCullough, MD principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oval-8 ® Orthosis and Cortisone injection only in people with Hand Injuries and Trigger Finger, run by Cedars-Sinai Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Theodore Brown, BS (800-700-6424, Theodore.Brown@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Trigger Finger Symptoms (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.