TENS for Back Pain Emergency Department

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    80
  • sponsor
    Stony Brook University
Updated on 10 May 2022
ibuprofen
back pain

Summary

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.

Description

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.

Details
Condition Back Pain
Treatment TENS, Sham TENS
Clinical Study IdentifierNCT04227067
SponsorStony Brook University
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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