TENS for Back Pain Emergency Department

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Device: TENS; Device: SHAM TENS

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam J Singer, MD; Phone Number: 6314447856; Email: adam.singer@stonybrook.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: TENS; An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Adam Singer, MD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: TENS, back pain, ibuprofen
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Back Pain
• Other Study ID Numbers: IRB2019-00435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes