TENS Efficacy on Acute Back Pain in an Emergency Department Triage

Completed · Not applicable · Has a placebo group

Conditions studied: Acute Back Injury

In brief

Transcutaneous Electrical Nerve Stimulation (TENS) devices produce a gentle electrical stimulation that when applied through pads applied directly to the skin, has a noticeable effect in reducing pain associated with various types of injuries and ailments. Several recent studies have shown efficacy when used for acute pain specific to primary dysmenorrhea, renal colic, lower-extremity pain, and pain associated with spinal cord injury, and was achieved without adverse effects. This study is intended to compare the effects of TENS units on acute back pain on ambulatory patients who are awaiting emergency medical treatment, to uncover if a statistically-significant analgesic effect is noted compared to a placebo device.

Key facts

Study ID

NCT03905681

Run by

William Beaumont Army Medical Center

People needed

44

Starts

2019-04-02

Expected to finish

2019-05-16

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Presents to the Emergency Department in an ambulatory status
• Has a complaint of traumatic back pain, acute or acute-on-chronic, which is 3 weeks or less in duration.
• Is designated to an Emergency Severity Index Category of 4 or 5.
• Patient must be unfamiliar with TENS use
• Projected wait time of greater than 30 minutes before a visit with an Emergency Department provider is anticipated based on triage category
• Not actively pregnant for female patients

You may not qualify if…

• Patient has a history of using TENS in the past
• Patient is actively pregnant
• History of narcotic use or abuse in the last 24 hours
• Patient has a cardiac pacemaker or a neurostimulation-implant device
• Patient is designated to an Emergency Severity Index Category of 1, 2, or 3
• Patient has an open wound, abrasion, skin rash, or tattoo < 6 weeks old where pads will be placed
• Patient has a current history of Low Back Pain 'red flags' (Bilateral radicular symptoms, saddle anesthesia or paresthesia, bladder incontinence, or bowel incontinence) which require immediate attention.

Where it is running

• William Beaumont Army Medical Center — Fort Bliss, Texas, United States

Full record on ClinicalTrials.gov

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