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Vibratory Anesthesia for Trigger Finger

Phase 4

Recruiting

Led By Tolga Turker, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the trigger finger injection is completed

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will compare the effectiveness of no topical anesthesia, topical coolant, and vibration in reducing pain during trigger finger injections.

Who is the study for?

This trial is for healthy adults diagnosed with trigger finger who need a steroid injection as part of their treatment. It's not suitable for those without a trigger finger diagnosis, those who don't require an injection, or individuals with reduced touch sensation in the affected area.

What is being tested?

The study compares three methods to reduce pain during trigger finger injections: no anesthesia, a topical coolant spray (Gebauers Ethyl Chloride), and vibration anesthesia device by Blaine Labs. Patients will be randomly assigned to one of these methods.

What are the potential side effects?

Potential side effects may include temporary discomfort at the site of application for both the topical coolant and vibration device. There are generally no significant side effects expected from these types of local anesthesia techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the trigger finger injection is completed

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the trigger finger injection is completed

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the trigger finger injection is completed for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Felt

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: VibrationExperimental Treatment1 Intervention

The subject will have a vibration device placed just proximal to the site of the trigger finger injection concurrent with the administration of the injection.

Group II: Topical coolantExperimental Treatment1 Intervention

The subject will have 5 seconds of sterile ethyl chloride sprayed at the site of the trigger finger injections just prior to the administration of the injection.

Group III: No topical anesthesiaActive Control1 Intervention

No topical anesthesia will be given during the trigger finger injection.

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