Back PainNCT07588490
Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments
A study testing transcutaneous electrical nerve stimulation (TENS) and FAKE TENS in people with Back Pain, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- transcutaneous electrical nerve stimulation (TENS) and FAKE TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- = or > 18 years old
- pain (EN > 3) related to acute lower back pain in the emergency department.
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Charles Grégoire, MD, 0032497534996, charles.gregoire@saintluc.uclouvain.be
Lara Absil, PhD, 003227648645, lara.absil@saintluc.uclouvain.be
About this study
Official title: 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.
Read more
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.
- Conditions
- Back Pain
- Being tested
- transcutaneous electrical nerve stimulation (TENS), FAKE TENS
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TENSDevice
The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Not described Receives: Device: transcutaneous electrical nerve stimulation (TENS) |
| FAKE TENS | Placebo comparator | Not described Receives: Device: FAKE TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 30 minutes
Secondary outcomes (4)
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.
Measured: From enrollment to the end of treatment at 30 minutes.
Compare the number of patients requiring rescue treatment.
Measured: From enrollment to the end of treatment at 30 minutes.
Compare the occurrence of side effects between the groups.
Measured: From enrollment to the end of treatment at 30 minutes.
Compare patient satisfaction levels and comfort at 30 minutes.
Measured: From enrollment to the end of treatment at 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start12 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588490
- Sponsor's protocol ID
- 2024/18NOV/504
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07588490
- Acronym / sponsor ID
- 2024/18NOV/504
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: transcutaneous electrical nerve stimulation (TENS) |
| FAKE TENS | Placebo comparator | Device: FAKE TENS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- = or > 18 years old
- pain (EN > 3) related to acute lower back pain in the emergency department.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | TENS |
| FAKE TENSThe device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active | Device | FAKE TENS |
Primary outcome
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.
4 secondary outcomes
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.
Compare the number of patients requiring rescue treatment.
Time frame: From enrollment to the end of treatment at 30 minutes.
Compare the occurrence of side effects between the groups.
Time frame: From enrollment to the end of treatment at 30 minutes.
Compare patient satisfaction levels and comfort at 30 minutes.
Time frame: From enrollment to the end of treatment at 30 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation (TENS) and FAKE TENS in people with Back Pain, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Grégoire, MD (0032497534996, charles.gregoire@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.