Nighttime Brace + Cortisone Injection for Trigger Finger

Overseen By Pam Roberts, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Rheumatoid arthritis, Hand injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

146 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if wearing a nighttime brace, combined with a cortisone injection (an anti-inflammatory medication), can more effectively relieve pain and improve function in people with trigger finger. Trigger finger causes fingers to lock or catch when bent, leading to pain and discomfort. Participants will be divided into two groups: one group will wear the brace at night after receiving the injection, while the other group will receive only the injection. This trial targets individuals with trigger finger who have already received a cortisone injection. As an unphased trial, the study offers an opportunity to explore new methods for managing trigger finger symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this nighttime orthosis is safe for treating trigger finger?

Past studies have found cortisone injections generally safe for treating trigger finger, with success rates after one injection ranging from 49% to 84%. Some individuals may require more than one injection, while a smaller group experiences complete symptom relief.

Research shows that the Oval-8 orthosis, a type of finger brace, is well-tolerated and effective in reducing pain and symptoms when used as instructed. Specifically, one study reported that 53.6% of participants experienced complete symptom relief after using the brace for six weeks.

Both treatments are considered safe based on current research, though individual results may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of combining a nighttime brace with a cortisone injection for treating trigger finger. Unlike the standard of care, which typically involves cortisone injections alone or surgery, this approach adds a nighttime orthosis designed to keep the finger in a stable position while you sleep. This combination could offer a non-surgical option that enhances healing, reduces discomfort, and speeds up symptom resolution. By evaluating this new approach, researchers hope to provide patients with a more effective and comfortable treatment alternative.

What evidence suggests that this trial's treatments could be effective for trigger finger?

Research has shown that cortisone injections effectively treat trigger finger, with success rates ranging from 45% to 80%. Approximately 66% of cases respond well to these injections. Most patients experience symptom relief, though some may eventually require surgery. In this trial, participants in the experimental group will receive a cortisone injection and use a supportive device at night, called an orthosis, which can improve results. Physical therapy, which includes using these devices, has a 69% success rate in reducing pain and finger locking. Overall, combining cortisone injections with a nighttime orthosis may enhance treatment effectiveness. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with trigger finger who have had a cortisone injection in the affected fingers. It's not suitable for those who haven't received this injection or may have other hand injuries.

Inclusion Criteria

I have trigger finger.

I have received a cortisone injection in my finger(s).

Exclusion Criteria

Any records flagged with break the glass or research opt out

Patients with a history of traumatic injury to the hand

Unable to speak and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cortisone injection and, for the experimental group, a nighttime orthosis for 6 weeks

6 weeks

1 visit (in-person) for injection and orthosis fitting

Follow-up

Participants are monitored for resolution of trigger finger symptoms and changes in pain and function

12 weeks

2 follow-up contacts (phone or email) at 6 and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cortisone injection
• Oval-8 ® Orthosis

Trial Overview

The study tests if wearing an Oval-8® Orthosis at night after a cortisone shot helps reduce pain and improve finger function compared to not using the orthosis following the treatment.

How Is the Trial Designed?

Group I: Experimental Group with Cortisone Injection of affected digit(s) and nighttime orthosis Experimental Treatment 1 Intervention

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.

Group II: Control Group-No Orthosis Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study of 73 patients with trigger finger, those receiving corticosteroid injections with lidocaine and epinephrine reported significantly higher pain levels immediately after the injection compared to those receiving corticosteroids with a placebo (VAS 3.5 vs 2.0).

The findings suggest that omitting the local anesthetic (lidocaine with epinephrine) from corticosteroid injections can reduce injection-associated pain, making the treatment simpler, more efficient, and safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic: A Randomized, Double-Blind Controlled Trial. Patrinely, JR., Johnson, SP., Drolet, BC.[2022]

In a study of 100 adult patients with 129 trigger fingers, extrasynovial steroid injections using betamethasone and lidocaine relieved pain in 98% of cases and reduced snapping in 74%, demonstrating high efficacy as a conservative treatment.

The study found no complications from the steroid injections, suggesting that this method is safe and effective without the need for more invasive procedures like tendon sheath injections or surgery, which was only required in 7 cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcome of extrasynovial steroid injection for trigger finger. Kazuki, K., Egi, T., Okada, M., et al.[2014]

In a study of 64 patients with trigger finger, those receiving betamethasone reported slightly higher baseline pain but lower pain levels on the first day after injection compared to those receiving methylprednisolone.

While the incidence of flare reactions was approximately double for betamethasone compared to methylprednisolone, this difference was not statistically significant, suggesting that both corticosteroids may have similar safety profiles in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Intensity of Pain and Incidence of Flare Reaction Following Trigger Finger Injections Using Betamethasone and Methylprednisolone: A Double-Blinded, Randomized Controlled Trial. Sraj, S., Schick, S., Wasef, K., et al.[2023]

A study of 780 patients who underwent open trigger finger release found that recent steroid injections are associated with a higher risk of postoperative infections, particularly when the injection occurs close to the surgery date.

Other identified risk factors for infection include older age, smoking, and the use of lidocaine with epinephrine, leading to recommendations for careful preoperative counseling and scheduling surgeries at least 80 days after the last steroid injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid Injection and Open Trigger Finger Release Outcomes: A Retrospective Review of 999 Digits. Ng, WKY., Olmscheid, N., Worhacz, K., et al.[2021]

Steroid injections into the flexor sheath at the A1 pulley level are effective in treating trigger finger, with evidence suggesting success in most patients based on a systematic review of the literature.

The study provides detailed anatomical guidance and techniques for safely administering the injection, minimizing the risk of injury to surrounding structures, making it a preferred treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study to outline the efficacy and illustrate techniques for steroid injection for trigger finger and thumb. Akhtar, S., Burke, FD.[2018]

Nighttime splinting for 6 weeks significantly reduced disability and pain in patients with recent onset idiopathic trigger fingers, with 55% of participants experiencing complete resolution of symptoms.

This noninvasive treatment is effective for individuals with symptoms lasting less than 3 months, providing an alternative to more invasive options like steroid injections for those who do not improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Night Splinting for Idiopathic Trigger Digits. Drijkoningen, T., van Berckel, M., Becker, SJE., et al.[2019]

Local corticosteroid injections are a safe and effective first-line treatment for trigger finger, achieving cure rates of about 50%, making them a practical option in general practice.

Both blind and ultrasound-guided corticosteroid injections are equally effective, and the placement of the steroid (either inside or outside the tendon sheath) does not affect the treatment outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Blind corticosteroid injection as primary treatment of trigger finger]. Kongensgaard, TB., Schroll, L., Hansen, RL.[2020]

In a study of 55 patients with 62 trigger fingers, local corticosteroid injections successfully treated 60 of the cases, demonstrating the efficacy of this simple procedure.

However, there is a notable recurrence rate of 33% within the first year after treatment, indicating that while the procedure is safe and effective, patients should be aware of the possibility of symptoms returning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Topical corticosteroid injection for 'trigger finger': good short-term results, but fairly high risk of recurrence]. van Ijsseldijk, AL., de Wilt, JH., Lameris, TW., et al.[2013]

The dorsal injection technique for corticosteroid treatment of trigger digits was found to have a mean distance of 1.77mm from the needle to the neurovascular bundle, indicating a relatively safe approach with a low risk of injury.

Out of 112 injections, only two neurovascular injuries occurred, suggesting that while the technique is generally safe, further clinical studies are needed to confirm its efficacy and safety in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dorsal web injection technique in the treatment of trigger finger and trigger thumb. Anatomical study. Jiménez, I., Garcés, GL., Caballero-Martel, J., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5382803/

Long-term Effectiveness of Repeat Corticosteroid Injections ...

While most patients ultimately require surgical release, 50% of patients receiving repeat trigger injections realize one year or more of symptomatic relief.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3504690/

The Efficacy of Steroid Injection in the Treatment of Trigger ...

The study found that 66% of trigger digits were effectively treated using steroid injections. There was a difference between the efficacy of the injection in ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03156829

Effectiveness of Cortisone Injection and Splinting for ...

Corticosteroid injection is considered the most effective treatment to resolve symptoms in nondiabetic patients, as the success rate is slightly lower in ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0894113024001698

A collaborative interdisciplinary approach for trigger finger ...

Success rates (i.e., absence of pain and triggering) with physical therapy management of trigger finger has been reported as 69%, with low recurrence rates.

5.

surgicoll.scholasticahq.com

surgicoll.scholasticahq.com/article/68065-trigger-finger-evaluation-management-and-outcomes

Trigger Finger: Evaluation, Management, and Outcomes

Local administration of corticosteroid injections has been shown to relieve trigger fingers, with reported rates ranging from 45 to 80% ...

6.

digitalcommons.wustl.edu

digitalcommons.wustl.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=4515&context=open_access_pubs

Long-term outcomes following a single corticosteroid ...

Exploring this association revealed a ten-year success rate of 56% for female patients presenting for the first time with a triggerfinger compared with 35% in ...

7.

journals.lww.com

journals.lww.com/jaaosglobal/fulltext/2023/02000/national_benchmarks_for_the_efficacy_of_trigger.2.aspx

National Benchmarks for the Efficacy of Trigger Finger and...

The existing literature has reported a wide range of success after corticosteroid injections; 49% to 84% after one injection, 24 , 25 , 27 - 29 23% to 86% after ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0363502316307249

Long-Term Effectiveness of Repeat Corticosteroid ...

Our data confirm that 39% of patients who fail a first or second corticosteroid injection for trigger finger may respond to a subsequent steroid injection.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7225882/

Steroid Injection and Open Trigger Finger Release Outcomes

Results: Steroid injection timing relative to subsequent operative intervention correlated with postoperative surgical site infection in trigger finger release.