TENS for Back Pain Emergency Department

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04227067

Enrollment

Registered

2020-01-13

Start date

2020-01-20

Completion date

2024-02-12

Last updated

2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

Keywords

TENS, back pain, ibuprofen

Brief 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.

Detailed 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.

Interventions

DEVICETENS

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

DEVICESHAM TENS

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain severity	30 minutes after application of TENS unit	Pain severity graded on a verbal numeric pain scales from none (0) to most (10)

Secondary

Measure	Time frame	Description
Use of rescue medications	30 minutes after application of the TENS unit	The percentage of patients that were administered an additional analgesic medication after the application of TENS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026