Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Dep… (NCT07588490) | Clinical Trial Compass
RecruitingNot Applicable
Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments
Belgium222 participantsStarted 2026-01-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the proportion of patients experiencing a >30% reduction in their initial pain after 30 minutes of treatment.
Timeframe: From enrollment to the end of treatment at 30 minutes
Trial details
NCT IDNCT07588490
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain