TENS for Back Pain Emergency Department

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227067
• Other study ID #: IRB2019-00435
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: February 12, 2024

Study information

• Verified date: February 2024
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 12, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Emergencies

Intervention

Device:
• TENS
An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.
• SHAM TENS
A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity	Pain severity graded on a verbal numeric pain scales from none (0) to most (10)	30 minutes after application of TENS unit
Secondary	Use of rescue medications	The percentage of patients that were administered an additional analgesic medication after the application of TENS	30 minutes after application of the TENS unit