Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments

Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments: a Randomised Controlled Trial

Acute low back pain is a common reason for emergency department visits (4.39% [95% CI: 3.67-5.18]). Drug treatment options are limited and largely ineffective. Paracetamol and opioids are no better than placebo for acute low back pain. Only NSAIDs and muscle relaxants have a slightly beneficial effect on pain, but muscle relaxants have an unfavorable benefit-risk ratio.

Given this situation, it is necessary to explore new non-pharmacological treatment options to relieve the pain of these patients. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological therapy that involves applying an electrical current through the skin. Using one or two pairs of electrodes attached to the skin, TENS delivers painless, low-intensity electrical pulses to a painful area or along the path of a nerve.

TENS works by selectively activating large-diameter, non-nociceptive afferent fibers to induce segmental analgesia. In addition, TENS increases the concentration of endorphins in the bloodstream and cerebrospinal fluid.

The use of TENS has been studied primarily in chronic low back pain. A 2007 Cochrane systematic review concluded that TENS appears to reduce pain and improve range of motion in subjects with chronic low back pain.

The use of TENS in the emergency department has been little studied. To our knowledge, there are no high-quality studies comparing TENS versus placebo for acute low back pain in patients presenting to an emergency department. This study aims to investigate the analgesic efficacy of TENS compared to placebo in the treatment of acute low back pain in the emergency department.

Study Overview

• Status: Recruiting
• Conditions: Back Pain
• Intervention / Treatment: Device: transcutaneous electrical nerve stimulation (TENS); Device: FAKE TENS

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Grégoire, MD; Phone Number: 0032497534996; Email: charles.gregoire@saintluc.uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-luc
    • Contact: Charles Grégoire, MD; Phone Number: 0032497534996; Email: charles.gregoire@saintluc.uclouvain.be
    • Contact: Lara Absil, PhD; Phone Number: 003227648645; Email: lara.absil@saintluc.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• = or > 18 years old
• pain (EN > 3) related to acute lower back pain in the emergency department.

Exclusion Criteria:

• Refusal to participate in the study, refusal to sign the informed consent form
• Consent cannot be obtained (cognitive impairment, language barrier, etc.)
• Patients with lower back pain lasting more than 6 weeks
• Taking immediate-release pain medication within the last 6 hours
• Taking extended-release pain medication within the last 12 hours
• Taking a muscle relaxant within the last 24 hours
• Pregnant women
• Patients requiring immediate medical attention (life-threatening situation)
• Patient already treated with TENS
• Patient with a body temperature > 38°C
• Patient with a known spinal infection
• Lower back pain related to trauma
• Patient with a known systemic rheumatological or spinal disease
• Patient with a known systemic inflammatory disease
• Patient with a known chronic pain condition such as fibromyalgia
• Patient with pain radiating into the lower limb along the path of one of the following nerves (L3-L4-L5-S1)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS	Device: transcutaneous electrical nerve stimulation (TENS); Transcutaneous electrical nerve stimulation (TENS) for group 1. The device is placed and is activated on the patient's back
Placebo Comparator: FAKE TENS	Device: FAKE TENS; The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the proportion of patients experiencing a >30% reduction in their initial pain after 30 minutes of treatment.	Pain is quantified using the EN numerical pain scale ranging from 0 (no pain present) to 10 (maximum pain). This is a self-assessment scale for the patient. The patient's pain level (according to EN numerical pain scale) is assessed at enrollment (Time 0) before the medical device is placed. A pain assessment using this scale is requested after 15 and 30 minutes.	From enrollment to the end of treatment at 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the number of patients experiencing a reduction of >50% in their initial pain.	Pain is quantified using the EN numerical pain scale ranging from 0 (no pain present) to 10 (maximum pain). This is a self-assessment scale for the patient. The patient's pain level (according to EN numerical pain scale) is assessed at enrollment (Time 0) before the medical device is placed. A pain assessment using this scale is requested after 15 and 30 minutes.	From enrollment to the end of treatment at 30 minutes.
Compare the number of patients requiring rescue treatment.		From enrollment to the end of treatment at 30 minutes.
Compare the occurrence of side effects between the groups.		From enrollment to the end of treatment at 30 minutes.
Compare patient satisfaction levels and comfort at 30 minutes.		From enrollment to the end of treatment at 30 minutes.

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: 2024/18NOV/504

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No