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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Charles Grégoire, MD
- Telefoonnummer: 0032497534996
- E-mail: charles.gregoire@saintluc.uclouvain.be
Studie Locaties
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Brussels, België, 1200
- Werving
- Cliniques universitaires Saint-Luc
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Contact:
- Charles Grégoire, MD
- Telefoonnummer: 0032497534996
- E-mail: charles.gregoire@saintluc.uclouvain.be
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Contact:
- Lara Absil, PhD
- Telefoonnummer: 003227648645
- E-mail: lara.absil@saintluc.uclouvain.be
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: TIENTALLEN
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Transcutaneous electrical nerve stimulation (TENS) for group 1.
The device is placed and is activated on the patient's back
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Placebo-vergelijker: FAKE TENS
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The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Comparison of the proportion of patients experiencing a >30% reduction in their initial pain after 30 minutes of treatment.
Tijdsspanne: From enrollment to the end of treatment at 30 minutes
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Compare the number of patients experiencing a reduction of >50% in their initial pain.
Tijdsspanne: From enrollment to the end of treatment at 30 minutes.
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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.
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Compare the number of patients requiring rescue treatment.
Tijdsspanne: From enrollment to the end of treatment at 30 minutes.
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From enrollment to the end of treatment at 30 minutes.
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Compare the occurrence of side effects between the groups.
Tijdsspanne: From enrollment to the end of treatment at 30 minutes.
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From enrollment to the end of treatment at 30 minutes.
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Compare patient satisfaction levels and comfort at 30 minutes.
Tijdsspanne: From enrollment to the end of treatment at 30 minutes.
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From enrollment to the end of treatment at 30 minutes.
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2024/18NOV/504
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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