Vibratory Anesthesia for Trigger Finger

Not currently recruiting at 1 trial location

Overseen By Joey F Ghotmi, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Arizona

Disqualifiers: Decreased light touch sensation, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to reduce pain during trigger finger injections. It compares no anesthesia, a topical spray (Gebauers Ethyl Chloride 100% Topical Spray), and a vibrating device (Vibration Anesthesia Device by Blaine Labs) to identify the most effective option for easing discomfort. Individuals diagnosed with trigger finger who require an injection may be suitable candidates. Participants will contribute to identifying the most effective pain relief method for future treatments. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that both treatments in this trial have available safety information. The Vibration Anesthesia Device has shown promise in reducing pain during injections. One study found it lowered pain scores by 25.5% for local anesthetic injections, indicating the device is generally well-tolerated, with no reported side effects in the available data.

Gebauer's Ethyl Chloride 100% Topical Spray is FDA-approved for managing pain during injections. However, as a flammable liquid, it must be used carefully to prevent fire risks. While it is usually safe for its intended use, no specific side effects have been reported in the reviewed sources.

Current evidence suggests both treatments are well-tolerated. Participants can feel reassured by the safety records of both options. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for trigger finger because they offer novel approaches to pain management during injections. The vibration anesthesia device by Blaine Labs is unique because it uses mechanical vibration just before the injection, which may distract the nervous system and reduce pain perception. On the other hand, Gebauers Ethyl Chloride 100% Topical Spray acts as a coolant by creating a numbing sensation on the skin's surface, potentially minimizing discomfort. These methods differ from the standard injection pain relief, which often relies on local anesthetics, by offering non-invasive and potentially quicker pain reduction techniques.

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

This trial will compare different methods for pain relief during trigger finger injections. Research has shown that a vibration device, used in one arm of this trial, can reduce pain during these injections. In a study with 174 injections, patients experienced less pain and felt more comfortable with the vibration device. Another arm of this trial will use ethyl chloride, a spray that numbs the skin. However, studies have shown that ethyl chloride has not been very effective for reducing pain in similar hand procedures. Specifically, a study with 126 patients found that using ethyl chloride before needle punctures did not significantly reduce pain. Therefore, current evidence suggests that vibration might be the better option for pain relief during trigger finger injections. ^{5 6 7 8 9}

Who Is on the Research Team?

Tolga Turker, MD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am healthy but need an injection for my trigger finger.

Exclusion Criteria

I do not have trigger finger or need an injection for it.

Subjects with known decreased light touch sensation in the territory of the trigger finger injection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive trigger finger injections with either no topical anesthesia, topical coolant, or vibration to assess pain reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels immediately after the injection using a visual analog pain scale

Immediately after treatment

What Are the Treatments Tested in This Trial?

Interventions

• Gebauers Ethyl Chloride 100% Topical Spray
• Vibration Anesthesia Device by Blaine Labs

Trial Overview 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.

How Is the Trial Designed?

Group I: Vibration Experimental Treatment 1 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 coolant Experimental Treatment 1 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 anesthesia Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

In a study involving 180 injections across three groups, vibratory anesthesia significantly reduced patient-reported pain during corticosteroid injections compared to no anesthesia, making it an effective option for pain management in hand and upper extremity procedures.

While both vibratory anesthesia and vapocoolant spray were found to decrease pain compared to no intervention, only vibratory anesthesia showed statistically significant results, suggesting it may be the more reliable method for reducing injection pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibratory Anesthesia's Effect on Pain Perception in Upper Extremity Corticosteroid Injections. Weeks, DW., Faillace, JJ.[2022]

In a study of 120 patients undergoing gynecological surgery, ethyl chloride was found to significantly reduce pain during venepuncture compared to no anaesthetic, demonstrating its effectiveness for instant skin anaesthesia.

However, ethyl chloride was less effective than intradermal lidocaine and did not improve vein visualization or ease of cannulation, suggesting it is a useful but not superior option for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Armstrong, P., Young, C., McKeown, D.[2018]

A case study of a 30-year-old woman revealed contact sensitization to ethyl chloride and dichlorodifluoromethane (CFC 12), leading to an itchy dermatitis after exposure to a medical aerosol, indicating that allergic reactions can occur despite the rarity of such cases.

The study suggests that the low incidence of contact allergy to these gases may be due to their rapid evaporation, which limits prolonged skin contact, and highlights the need for modified testing methods to evaluate volatile agents effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis from ethyl chloride and sensitization to dichlorodifluoromethane (CFC 12). Bircher, AJ., Hampl, K., Hirsbrunner, P., et al.[2019]

The use of vibration anesthesia with the DentalVibe device significantly reduced pain during digital block injections in the hand, with a mean pain score of 2.52 compared to 4.28 in the sham group, indicating its efficacy in pain management.

This randomized controlled trial involved 25 adult patients over a 24-month period, and the results suggest that microvibratory stimulation can effectively alleviate pain during local anesthetic procedures, warranting further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Dental Vibration Tool to Reduce Pain From Digital Blocks: A Randomized Controlled Trial. Pedersen, C., Miller, M., Xu, KT., et al.[2019]

A survey of 2,083 hand surgeons revealed that 59% frequently use ethyl chloride topical spray for hand injections, despite its documented risks like frostbite and skin irritation.

In a clinical study with 151 patients, there was no significant difference in pain or anxiety levels between those receiving injections with ethyl chloride and those without, suggesting that its use may not provide any clinical benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and Effectiveness of Ethyl Chloride for Hand Injections. Franko, OI., Stern, PJ.[2017]

A study tested the effects of ethyl chloride on 15 different types of bacteria and fungi, using 30 specimens sprayed for either 5 or 10 seconds.

The results showed that ethyl chloride does not inhibit the growth of normal skin flora, indicating it lacks bacteriostatic or cidal properties when used as a local anesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethyl chloride: an ineffective bacteriostatic or cidal agent for arthrocentesis. James, WS., Drez, D.[2017]

In a study involving 126 patients, the application of an ethyl chloride aerosol spray before arterial puncture did not significantly reduce pain compared to a placebo spray, with both groups reporting similar pain levels.

The trial was a single-blind, randomized placebo-controlled design, indicating a rigorous approach to testing the efficacy of the ethyl chloride spray in an emergency department setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial]. Ballesteros-Peña, S., Fernández-Aedo, I., Vallejo-De la Hoz, G.[2018]

Vibration anesthesia, using inexpensive massagers, effectively reduces discomfort during various dermatologic and cosmetic procedures, including botulinum toxin injections and laser therapies.

While vibration anesthesia may not completely eliminate pain, it significantly enhances the tolerability of injections, making it a valuable option for patients who are averse to needles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Smith, KC., Comite, SL., Balasubramanian, S., et al.[2022]

In a study of 60 patients, ethyl chloride spray significantly reduced pain during needle electromyography compared to a placebo, as indicated by lower scores on the visual analog scale and higher patient satisfaction.

While ethyl chloride effectively alleviated pain, it also increased the duration of the motor unit action potential, suggesting that while it is effective for pain relief, it may alter some electromyography parameters and should be used cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ethyl chloride spray on pain and parameters of needle electromyography in the upper extremity. Moon, YE., Kim, SH.[2016]

In a study involving 15 healthy adults, the application of ethyl chloride topical anesthetic spray did not significantly affect the sterility of injection sites after proper skin preparation, with only 5% of samples showing bacterial growth post-application.

Despite ethyl chloride being labeled as nonsterile, its use after skin preparation did not increase the risk of contamination at the injection site, suggesting it can be safely used in outpatient procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin sterility after application of ethyl chloride spray. Polishchuk, D., Gehrmann, R., Tan, V.[2016]

In a study involving 10 volunteers, the Vibraject vibrating dental anesthesia attachment did not significantly reduce pain during needle insertion or anesthetic injection when compared to standard methods.

The results suggest that the clinical effectiveness of Vibraject in reducing injection pain is still uncertain, indicating that further research may be needed to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of pain reduction by a vibrating local anesthetic attachment: a pilot study. Saijo, M., Ito, E., Ichinohe, T., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05405452

Vibratory Anesthesia in Trigger Finger Injections This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction of pain during ...

2. clinicaltrial.be clinicaltrial.be/en/details/16714?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Vibratory Anesthesia in Trigger Finger Injections - Clini... This study aims to compare the effectiveness of the use of no topical anesthesia, topical coolant, and the use of vibration in the reduction ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28259274/

Use and Effectiveness of Ethyl Chloride for Hand Injections Ethyl chloride is widely used among hand surgeons but imparts no benefit for routine hand injections in the clinical setting.

4. withpower.com withpower.com/trial/phase-trigger-finger-5-2022-108da

Vibratory Anesthesia for Trigger Finger · Info for Participants In a study involving 126 patients, the application of an ethyl chloride aerosol spray before arterial puncture did not significantly reduce pain compared to a ...

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K190161.pdf

May 7, 2019 Gebauer Company Brittney Cooper Sr ... Gebauer's Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deliver ethyl chloride in a mist, fine or medium spray.

6. gebauer.com gebauer.com/hubfs/docs/SDS%202024%20Update/Ethyl%20Chloride%20SDS.pdf

SAFETY DATA SHEET (SDS) Flammable liquid and gas. Very dangerous fire hazard when exposed to heat, flame or powerful oxidizers. Ethyl chloride is heavier than air and the vapors may ...

7. gebauer.com gebauer.com/ethylchloride

Ethyl Chloride - Instant Topical Anesthetic Spray Gebauer's Ethyl Chloride instant topical anesthetic spray (vapocoolant) is FDA cleared to temporarily control the pain associated with injections.

8. smeincusa.com smeincusa.com/Ethyl-Chloride-Spray_LN?srsltid=AfmBOoqPzbmD4Q9bCHNrWqfpSFvS0hGQ5GibEOfWntqb9oI79Hl40p2i

Ethyl Chloride Spray See Safety Data Sheet under the Additional Information tab above. The stream spray is intended for use as a counterirritant in the management of Myofascial Pain ...

9. mms.mckesson.com mms.mckesson.com/product/635702/Gebauer-0038-6000-104

Gebauer's Ethyl Chloride® Ethyl Chloride 100% Gebauer's Ethyl Chloride skin refrigerant is intended for topical ... trigger point, restricted motion, and muscle tension; FDA approved for use prior to ...