Active TENS for Pain Management

N/A

Waitlist Available

Led By Leanne McCloskey, MD, MPH

Research Sponsored by Ashley Turner, MD

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 24-36 hours after dilator placement, immediately prior to d&e

Summary

This study evaluates the use of Transcutaneous Electrical Nerve Stimulation (TENS) as a method of pain control during osmotic dilator insertion prior to dilation and evacuation. Half the group will have an active TENS unit and half will have a sham or placebo TENS unit.

Eligible Conditions

Pain Management

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-36 hours after dilator placement, immediately prior to d&e

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-36 hours after dilator placement, immediately prior to d&e

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-36 hours after dilator placement, immediately prior to d&e 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 Following Dilator Placement

Secondary study objectives

Interval Pain

Patient Satisfaction

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TENSExperimental Treatment1 Intervention

The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation

Group II: Sham TENSPlacebo Group1 Intervention

The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS

2011

Completed Phase 2

~2040

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