Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous electrical nerve stimulation (TENS), FAKE TENS.
- Who it may be relevant to
- Registry conditions: Back Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Acute Low Back Pain With Transcutaneous Electrical Neurostimulation in Emergency Departments: a Randomised Controlled Trial
Overview
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.
Interventions
- Device 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 FAKE TENS
The device is placed on the patient's back even in the placebo group (FAKE TENS) but it is not active
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Cliniques Universitaires Saint-Luc — Brussels
Identifiers
NCT: NCT07588490 · 2024/18NOV/504