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Completed

NCT Number: NCT04227067

TENS for Back Pain Emergency Department

In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

About this study

Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults age 18 years or greater
  • Able to consent
  • Back pain of less than 2 weeks duration
  • Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)

Exclusion criteria

  • Pregnant patients
  • Minors
  • Prisoners
  • Neurological deficits

Treatment and study plan

TENS

Device

An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.

SHAM TENS

Device

A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.

Primary outcomes

  1. Pain severity

    Time frame: 30 minutes after application of TENS unit

    Pain severity graded on a verbal numeric pain scales from none (0) to most (10)

Secondary outcomes

  1. Use of rescue medications

    Time frame: 30 minutes after application of the TENS unit

    The percentage of patients that were administered an additional analgesic medication after the application of TENS

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Registry information

Official study title

The Use of TENS for the Treatment of Back Pain in the Emergency Department

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2020
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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