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

ConditionBack Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

= or > 18 years old

pain (EN > 3) related to acute lower back pain in the emergency department.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: TENSExperimental treatment 1 intervention
Group B: FAKE TENSPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 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.

Other outcomes

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