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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment for trigger finger?

Corticosteroid injections are a common and effective treatment for trigger finger, with studies showing they relieve pain and snapping in most cases, although there is a risk of recurrence. Nighttime splinting has also been assessed as a treatment for trigger fingers, suggesting a potential benefit when combined with other therapies. ^{1 2 3 4 5}

Is the combination of nighttime brace and cortisone injection safe for treating trigger finger?

Cortisone injections are generally safe for treating trigger finger, but they can cause side effects like pain during injection and increased risk of infection if surgery follows soon after. Using a nighttime brace is not associated with significant safety concerns. ^{1 6 7 8 9}

How does the nighttime brace and cortisone injection treatment for trigger finger differ from other treatments?

This treatment combines a nighttime brace with a cortisone injection, which is unique because it uses both a physical support and a medication to address trigger finger. While cortisone injections alone are a common treatment, the addition of a nighttime brace may provide extra support and potentially enhance the overall effectiveness of the treatment. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Blind corticosteroid injection as primary treatment of trigger finger]. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Night Splinting for Idiopathic Trigger Digits. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Trigger Finger Corticosteroid Injection With and Without Local Anesthetic: A Randomized, Double-Blind Controlled Trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Topical corticosteroid injection for 'trigger finger': good short-term results, but fairly high risk of recurrence]. [2013]

5. Singapore pubmed.ncbi.nlm.nih.gov

Clinical outcome of extrasynovial steroid injection for trigger finger. [2014]

6. Spain pubmed.ncbi.nlm.nih.gov

Dorsal web injection technique in the treatment of trigger finger and trigger thumb. Anatomical study. [2021]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Study to outline the efficacy and illustrate techniques for steroid injection for trigger finger and thumb. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Steroid Injection and Open Trigger Finger Release Outcomes: A Retrospective Review of 999 Digits. [2021]