Acute Back PainTENS BACK PAINNCT07183176
Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation at the Emergency Department: a Randomized Controlled Trial
A study testing Chattanooga CEFAR Tens in people with Acute Back Pain and Emergency Department Patient, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
Acute low back pain is a frequent cause of emergency department admissions (4.39% [95% CI: 3.67-5.18])1. Drug therapeutic options are limited and ineffective. Paracetamol and opioids are no better than placebo for acute low-back pain 2,3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Back Pain, Emergency Department Patient
- What is being tested?
- Chattanooga CEFAR Tens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 Sep 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
- All patients admitted to the emergency department and aged over 18 years with pain (EN > 3) related to acute low back pain.
- The lumbar region is defined as the anatomical area between the costal margin and the gluteal fold.
- Acute low back pain is defined by the World Health Organisation, and by part of the literature, as a low back pain that appeared less than 6 weeks ago.
Who cannot join
- Refusal to participate in study, refusal to sign informed consent
- Consent is impossible to obtain (cognitive impairment, language barrier, etc.)
- Patients with low back pain lasting more than > 6 weeks
- Pregnant women
- Patient requiring immediate medical attention (vital distress).
- Patient already treated with a TENS
Show all 13Show fewer
- Patient with a body temperature > 38°C
- Patient known to have a spinal infection
- Lumbar pain linked to trauma
- Patient with known systemic or spinal rheumatological disease
- Patient with a known systemic inflammatory disease
- A patient with a known chronic pain condition such as fibromyalgia
- Patient with pain radiating into the lower limb along the course of one of the following nerves (L3-L4-L5- S1)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Acute low back pain is a frequent cause of emergency department admissions (4.39% [95% CI: 3.67-5.18])1. Drug therapeutic options are limited and ineffective. Paracetamol and opioids are no better than placebo for acute low-back pain 2,3. Only NSAIDs and muscle relaxants have a slightly beneficial effect on pain, but muscle relaxants have an unfavorable risk-benefit balance.2 In this situation, it is necessary to turn to new non-drug therapeutic options to relieve pain of these patients. Transcutaneous electrical nerve stimulation (TENS) is a non-drug therapy that involves applying an electrical current through the skin. Through one or two pairs of electrodes stuck to the skin, TENS delivers painless, low-intensity electrical impulses to a painful area or a nerve pathway.
TENS acts by selectively activating large-diameter non-nociceptive afferent fibers to induce segmental analgesia4. In addition, TENS increases the concentration of endorphins in the bloodstream and cerebrospinal fluid5.
Read more
The use of TENS has been studied mainly in chronic low-back pain. A 2007 Cochrane systematic review concluded that TENS appears to reduce pain and improve range of motion for subjects with chronic low back pain6.
The use of TENS in emergency departments has been little studied. A 2018 pilot study of 110 patients admitted to the emergency department with acute or chronic pain observed a reduction in pain (from an average of 8.50 on the numerical pain scale [EN] [7.52 - 9.48] to 4.67 [3.51 - 5.89]) after TENS use and functional improvement in 83% of patients7.
The Gulacti study, carried out in 2022, investigated the use of TENS to treat pain of patients admitted to the emergency department with a renal colic attack : the mean reduction in VAS score at 15 and 30 minutes was significantly greater for the TENS group than for the placebo group (mean reduction in VAS score at 15 minutes was 33.3 ± 17.6 (95% CI : 28.3 to 38.3) for the TENS group and 14.9 ± 11.6 (95% CI: 11.6 to 18.2) for the placebo group [mean difference: 18.4 (95% CI: 12.5 to 24.4, P < 0.0001)]. The mean reduction in VAS score after 30 minutes was 63.7 ± 21.1 (95% CI: 57.7 to 69.7) for the TENS group and 14.9 ± 16.2 (95% CI: 19.5 to 10.3) for the placebo group (mean difference: 48.8, 95% CI: 41.4 to 56.3, P < 0.0001)8.
A single study of 76 patients focused on acute low-back pain during patient transport to emergency departments. The authors recorded a significant reduction (p= 0.01) in pain during transport of the TENS group (79.2 ± 6.5 mm VAS to 48.9 ± 8.2 0 mm VAS), while pain scores remained unchanged for the placebo group (75.9 ± 16.4 mm VAS and 77.1 ± 11.2 mm VAS)9.
To our knowledge, there is no high-quality study of TENS versus placebo for acute low back pain of patients admitted to an emergency department.
- Primary objective: Study the analgesic efficacy of TENS compared to placebo in the treatment of acute low back pain at the emergency department.
- Secondary objective:
- Compare the number of patients who will show a > 50% reduction of their initial pain.
- Compare the number of patients requiring rescue treatment. 3. Compare the occurrence of side effects among groups. 4. Compare patient satisfaction after 30 minutes. 5. Compare patient comfort level after 30 minutes.
Main criterion:
Comparison of the proportion of patients with >30% reduction of initial pain after 30 minutes of treatment
Secondary criterion:
- Proportion of patients with > 50% reduction of their initial pain after 30 minutes of treatment.
- Proportion of patients requiring morphine titration for pain relief.
- The rate of side-effects associated with the use of TENS.
- The level of satisfaction measured by numerical satisfaction scale ranging from 0 (not at all satisfied) to 10 (extremely satisfied) EN. A patient will be considered very satisfied if he/she presents a satisfaction level ≥ 8.
- The level of comfort will be assessed by a comfort scale ranging from 0 (not at all comfortable) to 10 (very comfortable patient).
- Conditions
- Acute Back Pain, Emergency Department Patient
- Being tested
- Chattanooga CEFAR Tens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chattanooga CEFAR TensDevice
Also called FAKE Tens
- The patient will be assigned to one of two groups:
- The intervention group: called the REAL TENS group (R- TENS)
- The control group: called the FAKE TENS group (F-TENS) Step 2: The doctor "investigator 1" will place the TENS on the painful area identified by the patient, following the model proposed in appendix 1. Step 3: The doctor "investigator 1" will explain to patients in both groups that they may feel a slight tingling sensation or no sensation at all. Step 4: The doctor "investigator 1" will make the following settings on the TENS:
- For the interventional group (REAL TENS) a combined setting will be used:
- Tens Burst (P2) at 2Hz and 180 µs with an action on muscle pain.
- Tens gate control (P9) at 100 Hz and 250 µs with an action focused on nociceptive pain.
- For the control group (FAKE TENS), the doctor will not make any "real" adjustments.
The patient will not be able to see the settings made by the doctor "investigator 1".
Stage 5: The doctor "investigator
| Study group | Role | What they receive |
|---|---|---|
| REAL TENS group (R- TENS) | Experimental | The intervention group. Chattanooga CEFAR Tens Receives: Device: Chattanooga CEFAR Tens |
| FAKE TENS group (F-TENS) | Placebo comparator | The control group Receives: Device: Chattanooga CEFAR Tens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of patients with >30% reduction of initial pain after 30 minutes of treatment
Measured: 30 minutes
Secondary outcomes (5)
Proportion of patients with > 50% reduction of their initial pain after 30 minutes of treatment.
Measured: 30 minutes
Proportion of patients requiring morphine titration for pain relief.
Measured: 30 minutes
The rate of side-effects associated with the use of TENS.
Measured: 30 minutes
The level of satisfaction measured by numerical satisfaction scale ranging from 0 (not at all satisfied) to 10 (extremely satisfied) EN. A patient will be considered very satisfied if he/she presents a satisfaction level ≥ 8.
Measured: 30 minutes
The level of comfort will be assessed by a comfort scale ranging from 0 (not at all comfortable) to 10 (very comfortable patient).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183176
- Sponsor's protocol ID
- 202418NOV504
- Acronym
- TENS BACK PAIN
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. 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 at the Emergency Department: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07183176
- Acronym / sponsor ID
- TENS BACK PAIN / 202418NOV504
- Conditions
- Acute Back Pain, Emergency Department Patient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 19 Sep 2025 (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 frequent cause of emergency department admissions (4.39% [95% CI: 3.67-5.18])1. Drug therapeutic options are limited and ineffective. Paracetamol and opioids are no better than placebo for acute low-back pain 2,3. Only NSAIDs and muscle relaxants have a slightly beneficial effect on pain, but muscle relaxants have an unfavorable risk-benefit balance.2 In this situation, it is necessary to turn to new non-drug therapeutic options to relieve pain of these patients. Transcutaneous electrical nerve stimulation (TENS) is a non-drug therapy that involves applying an electrical current through the skin. Through one or two pairs of electrodes stuck to the skin, TENS delivers painless, low-intensity electrical impulses to a painful area or a nerve pathway.
TENS acts by selectively activating large-diameter non-nociceptive afferent fibers to induce segmental analgesia4. In addition, TENS increases the concentration of endorphins in the bloodstream and cerebrospinal fluid5.
The use of TENS has been studied mainly in chronic low-back pain. A 2007 Cochrane systematic review concluded that TENS appears to reduce pain and improve range of motion for subjects with chronic low back pain6.
The use of TENS in emergency departments has been little studied. A 2018 pilot study of 110 patients admitted to the emergency department with acute or chronic pain observed a reduction in pain (from an average of 8.50 on the numerical pain scale [EN] [7.52 - 9.48] to 4.67 [3.51 - 5.89]) after TENS use and functional improvement in 83% of patients7.
The Gulacti study, carried out in 2022, investigated the use of TENS to treat pain of patients admitted to the emergency department with a renal colic attack : the mean reduction in VAS score at 15 and 30 minutes was significantly greater for the TENS group than for the placebo group (mean reduction in VAS score at 15 minutes was 33.3 ± 17.6 (95% CI : 28.3 to 38.3) for the TENS group and 14.9 ± 11.6 (95% CI: 11.6 to 18.2) for the placebo group [mean difference: 18.4 (95% CI: 12.5 to 24.4, P < 0.0001)]. The mean reduction in VAS score after 30 minutes was 63.7 ± 21.1 (95% CI: 57.7 to 69.7) for the TENS group and 14.9 ± 16.2 (95% CI: 19.5 to 10.3) for the placebo group (mean difference: 48.8, 95% CI: 41.4 to 56.3, P < 0.0001)8.
A single study of 76 patients focused on acute low-back pain during patient transport to emergency departments. The authors recorded a significant reduction (p= 0.01) in pain during transport of the TENS group (79.2 ± 6.5 mm VAS to 48.9 ± 8.2 0 mm VAS), while pain scores remained unchanged for the placebo group (75.9 ± 16.4 mm VAS and 77.1 ± 11.2 mm VAS)9.
To our knowledge, there is no high-quality study of TENS versus placebo for acute low back pain of patients admitted to an emergency department.
- Primary objective: Study the analgesic efficacy of TENS compared to placebo in the treatment of acute low back pain at the emergency department.
- Secondary objective:
- Compare the number of patients who will show a > 50% reduction of their initial pain.
- Compare the number of patients requiring rescue treatment. 3. Compare the occurrence of side effects among groups. 4. Compare patient satisfaction after 30 minutes. 5. Compare patient comfort level after 30 minutes.
Main criterion:
Comparison of the proportion of patients with >30% reduction of initial pain after 30 minutes of treatment
Secondary criterion:
- Proportion of patients with > 50% reduction of their initial pain after 30 minutes of treatment.
- Proportion of patients requiring morphine titration for pain relief.
- The rate of side-effects associated with the use of TENS.
- The level of satisfaction measured by numerical satisfaction scale ranging from 0 (not at all satisfied) to 10 (extremely satisfied) EN. A patient will be considered very satisfied if he/she presents a satisfaction level ≥ 8.
- The level of comfort will be assessed by a comfort scale ranging from 0 (not at all comfortable) to 10 (very comfortable patient).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REAL TENS group (R- TENS) | Experimental | Device: Chattanooga CEFAR TensThe intervention group. Chattanooga CEFAR Tens |
| FAKE TENS group (F-TENS) | Placebo comparator | Device: Chattanooga CEFAR TensThe control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients admitted to the emergency department and aged over 18 years with pain (EN > 3) related to acute low back pain.
- The lumbar region is defined as the anatomical area between the costal margin and the gluteal fold.
- Acute low back pain is defined by the World Health Organisation, and by part of the literature, as a low back pain that appeared less than 6 weeks ago.
Key exclusion criteria (13 listed)
- Refusal to participate in study, refusal to sign informed consent
- Consent is impossible to obtain (cognitive impairment, language barrier, etc.)
- Patients with low back pain lasting more than > 6 weeks
- Pregnant women
- Patient requiring immediate medical attention (vital distress).
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 |
|---|---|---|
| Chattanooga CEFAR TensAlso: FAKE Tens* The patient will be assigned to one of two groups: 1. The intervention group: called the REAL TENS group (R- TENS) 2. The control group: called the FAKE TENS group (F-TENS) Step 2: The doctor "investigator 1" will place the TENS on the painful area identified by the patient, following the model proposed in appendix 1. Step 3: The doctor "investigator 1" will explain to patients in both groups that they may feel a slight tingling sensation or no sensation at all. Step 4: The doctor "investigator 1" will make the following settings on the TENS: * For the interventional group (REAL TENS) a combined setting will be used: 1. Tens Burst (P2) at 2Hz and 180 µs with an action on muscle pain. 2. Tens gate control (P9) at 100 Hz and 250 µs with an action focused on nociceptive pain. * For the control group (FAKE TENS), the doctor will not make any "real" adjustments. The patient will not be able to see the settings made by the doctor "investigator 1". Stage 5: The doctor "investigator | Device | FAKE TENS group (F-TENS), REAL TENS group (R- TENS) |
Primary outcome
Comparison of the proportion of patients with >30% reduction of initial pain after 30 minutes of treatment
Time frame: 30 minutes
5 secondary outcomes
Proportion of patients with > 50% reduction of their initial pain after 30 minutes of treatment.
Time frame: 30 minutes
Proportion of patients requiring morphine titration for pain relief.
Time frame: 30 minutes
The rate of side-effects associated with the use of TENS.
Time frame: 30 minutes
The level of satisfaction measured by numerical satisfaction scale ranging from 0 (not at all satisfied) to 10 (extremely satisfied) EN. A patient will be considered very satisfied if he/she presents a satisfaction level ≥ 8.
Time frame: 30 minutes
The level of comfort will be assessed by a comfort scale ranging from 0 (not at all comfortable) to 10 (very comfortable patient).
Time frame: 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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Chattanooga CEFAR Tens in people with Acute Back Pain and Emergency Department Patient, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 gregoire, 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 with >30% reduction of initial pain after 30 minutes of treatment (time frame: 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 19 Sep 2025.