NCT04227067

TENS for Back Pain Emergency Department

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Back Pain

Interventions

Type	Name	Description
DEVICE	TENS	An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.
DEVICE	SHAM TENS	A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.

Timeline

• Start date: 2020-01-20
• Primary completion: 2024-02-12
• Completion: 2024-02-12
• First posted: 2020-01-13
• Last updated: 2024-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study