TENS and Vibration for Procedural Pain

(E-MOHS Trial)

Not yet recruiting at 3 trial locations
AF
IM
Overseen ByIan Maher, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a combination of vibration and transcutaneous electrical nerve stimulation (TENS) can reduce pain during local anesthesia for skin surgeries, such as Mohs surgery or dermatologic excision. Participants will receive either the active treatment or a placebo-like version (a fake treatment) to compare reported pain levels. The trial also examines factors like anxiety during the procedure and participant satisfaction with the device. This trial suits adults scheduled for skin surgery who have never used TENS and can describe their pain levels. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pain management techniques for future patients.

What prior data suggests that this device is safe for reducing procedural pain?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is safe for managing pain. Studies have found that TENS usually carries a low risk of infections or tissue damage because it uses gentle electrical signals to stimulate nerves, avoiding surgery.

In various studies, patients using TENS reported significantly less pain. For example, one study found that TENS reduced the need for painkillers after surgery, indicating that many people tolerate it well. Another study confirmed that TENS is safe and effective for nerve pain.

Overall, TENS is well-tolerated by users and rarely causes serious side effects, making it a dependable choice for managing pain without the risks of more invasive treatments.12345

Why are researchers excited about this trial?

Researchers are excited about using TENS (transcutaneous electrical nerve stimulation) combined with vibration for procedural pain because it offers a non-invasive, drug-free alternative to traditional pain management methods, like local anesthetics and oral pain medications. This approach works by delivering electrical impulses and vibratory stimulation to the skin, which can help distract the nervous system and reduce the sensation of pain during procedures like Mohs micrographic surgery. Unlike typical pain medications that can take time to act or cause side effects, this method has the potential to provide immediate pain relief with minimal risk. Additionally, the use of a sham TENS as a comparator helps ensure that any observed benefits are due to the active treatment, not just a placebo effect.

What evidence suggests that active vibration plus TENS is effective for reducing procedural pain?

This trial will compare the effectiveness of active vibration combined with transcutaneous electrical nerve stimulation (TENS) against a sham TENS treatment for managing procedural pain. Research has shown that using TENS with vibration can help reduce pain. Studies have found that TENS can significantly relieve pain, with some people experiencing up to a 50% decrease in pain intensity. In another study, 83.9% of TENS users reported excellent or partial pain relief. Vibration therapy also reduces pain, with about 59% of patients feeling more than 50% relief. Together, these methods seem promising for managing pain during procedures like receiving a local anesthetic.678910

Who Is on the Research Team?

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Ian Maher, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults having Mohs surgery or skin cancer removal who will receive local anesthesia. People with certain medical devices, nerve disorders, or conditions that make TENS unsafe may not be able to join.

Inclusion Criteria

I have never used a TENS device before.
I can understand and rate my pain on standard pain scales.
English-speaking and able to provide informed consent in English
See 1 more

Exclusion Criteria

I need electrodes placed on the front of my neck or over my carotid artery.
I have epilepsy or a seizure disorder.
Students of the researcher
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive either active vibration:TENS or sham TENS during local anesthetic infiltration

1 day
1 visit (in-person)

Follow-up

Adverse events are monitored through the standard post-operative period as part of routine clinical care

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Active Vibration:TENS

Trial Overview

The study compares using vibration plus electrical nerve stimulation (TENS) versus a fake (sham) TENS device during numbing injections to see if it reduces pain in people undergoing skin cancer surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Vibration:TENSExperimental Treatment1 Intervention
Group II: Sham TENSPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

Transcutaneous electrical nerve stimulation and ...

Both therapies appear to be effective Significant pain decrease in both groups global evaluation of acute and chronic pain.

2.

physicaltherapyfirst.com

physicaltherapyfirst.com/blog/tag/tens/

Using TENS for Pain Control: The State of the Evidence

The review identified a total of 23 studies meeting the inclusion criteria, with results showing mixed outcomes for TENS use in pain control.

The Efficacy, Use, And Safety of The Transcutaneous ...

Studies show that TENS can significantly reduce pain intensity (SMD for pain intensity: -0.47 to -1.28) in osteoarthritis and management.

Palliative Pain Management Using Transcutaneous ...

At short term assessment excellent result was reported by 17.8% partial alleviation of pain by 66.1% and failure by 16.1% of patients.

Long-term results of vibratory stimulation as a pain ...

About half of the successfully relieved patients (59% of the total number of patients) reported more than 50% pain relief, as scored on a visual analogue and ...

MAUDE Adverse Event Report: TRANSCUTANEOUS ...

MAUDE Adverse Event Report: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF.

Postoperative pain relief by transcutaneous electrical nerve ...

Patients on TENS demonstrated a marked significant decrease in the amount of narcotics administered. There was favorable nursing, physician and patient ...

"Is the use of Transcutaneous Electrical Nerve Stimulation ...

CONCLUSIONS: The use of TENS is both safe and effective in preventing and treating postherpetic neuralgia. Recommended Citation. Suzenski, Danielle, "Is the use ...

Understanding Transcutaneous Electrical Nerve Stimulation ...

At its core, TENS is the delivery of mild electrical stimuli designed to relieve both acute and chronic pain. Rather than just "numbing" an area ...

Transcutaneous electrical nerve stimulation for relieving ...

Transcutaneous electrical stimulation has been reported to be generally safe, with a low risk of infection or tissue damage as it does not ...