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NCT Number: NCT07588490

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

FAKE TENS

Device

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

Primary outcomes

  1. Comparison of the proportion of patients experiencing a >30% reduction in their initial pain after 30 minutes of treatment.

    Time frame: From enrollment to the end of treatment at 30 minutes

    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.

Secondary outcomes

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

    Time frame: From enrollment to the end of treatment at 30 minutes.

    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.

  2. Compare the number of patients requiring rescue treatment.

    Time frame: From enrollment to the end of treatment at 30 minutes.

  3. Compare the occurrence of side effects between the groups.

    Time frame: From enrollment to the end of treatment at 30 minutes.

  4. Compare patient satisfaction levels and comfort at 30 minutes.

    Time frame: From enrollment to the end of treatment at 30 minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Grégoire, MD

CONTACT

[email protected]

0032497534996

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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