TENS for Back Pain Emergency Department

Not Applicable

Completed

• Conditions: Back Pain
• Interventions: Device: SHAM TENS; Device: TENS

• Registration Number: NCT04227067
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-01-20
• Status Verified: 2024-02
• Primary Completion: 2024-02-12
• Study Completion: 2024-02-12
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM TENS	SHAM TENS	In the SHAM TENS group the TENS pads will be attached to the pulse generator and the patients skin around the painful area. The investigator will turn the knobs on but the batteries will be removed from the device.
TENS	TENS	A TENS device consists of an electric pulse generator and pads that are attached to the skin on around the area of maximal pain. We will use the conventional mode, which provides nerve stimulation with a pulse width of 60 microseconds and a pulse rate of 60 pulses per second. The channel intensity will be gradually increased until the intensity is noticeable but not painful.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 Stony Brook, New York, United States