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

NCT07588490 | Recruiting

• 1 other identifier: 2024/18NOV/504
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Compare the number of patients experiencing a reduction of >50% in their initial pain.

  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.

Study Arms (2)

TENS

EXPERIMENTAL

Device: transcutaneous electrical nerve stimulation (TENS)

FAKE TENS

PLACEBO COMPARATOR

Device: FAKE TENS

Interventions

transcutaneous electrical nerve stimulation (TENS) DEVICE

Transcutaneous electrical nerve stimulation (TENS) for group 1. The device is placed and is activated on the patient's back

TENS

FAKE TENS DEVICE

The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active

FAKE TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Charles Grégoire, MD

CONTACT

0032497534996; charles.gregoire@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 14, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

BE (1)