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

8. maj 2026 opdateret af: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

222

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TIDER
Enhed: 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 komparator: FAKE TENS
Enhed: FAKE TENS
The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of the proportion of patients experiencing a >30% reduction in their initial pain after 30 minutes of treatment.
Tidsramme: 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.
From enrollment to the end of treatment at 30 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare the number of patients experiencing a reduction of >50% in their initial pain.
Tidsramme: 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.
From enrollment to the end of treatment at 30 minutes.
Compare the number of patients requiring rescue treatment.
Tidsramme: From enrollment to the end of treatment at 30 minutes.
From enrollment to the end of treatment at 30 minutes.
Compare the occurrence of side effects between the groups.
Tidsramme: From enrollment to the end of treatment at 30 minutes.
From enrollment to the end of treatment at 30 minutes.
Compare patient satisfaction levels and comfort at 30 minutes.
Tidsramme: From enrollment to the end of treatment at 30 minutes.
From enrollment to the end of treatment at 30 minutes.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. januar 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

24. april 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024/18NOV/504

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Rygsmerte

Kliniske forsøg med transcutaneous electrical nerve stimulation (TENS)

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Betingelser

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