Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain

Primary Objective:

To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain.

Secondary Objectives:

* To assess the efficacy of ITP FIRTECH on participant disability
* To assess the efficacy of ITP FIRTECH on the degree of participant mobility
* To assess the safety of ITP FIRTECH

Duration of study participation is up to 6 days per participant.

Eligibility Criteria:
Inclusion Criteria:

* Participants suffering from mild to moderate acute low back pain
* Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold
* Acute episode is defined as acute pain with less than 1 month duration
* With intensity less than or equal to 6 on 0-10 Numerical Rating Scale (NRS)

Exclusion Criteria:

* Participants suffering from any neurological pathology which could be responsible of the pain
* Participants suffering from leg pain irradiation
* Participants suffering from chronic lumbar pain of any etiology
* Participants with chronic arthrosis and neurological symptoms
* Participants experiencing recent significant trauma (i.e., injury related to a fall from a height or motor vehicle crash, or from a minor fall or heavy lifting in a participants with osteoporosis or possible osteoporosis)
* Participants with major or progressive motor or sensory deficit, new-onset bowel or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle anesthesia, history of cancer metastatic to bone, and suspected spinal infection
* Participants clinically diagnosed with anxiety and/or depression
* Participants using any medication for their pain within the last 48 hours within enrollment into the study
* Participants taking any systemic medication for their pain within the last 24 hours (48 hours for diclofenac or corticosteroids)
* Participants currently using recreational or illicit drugs or with a recent history of drug or alcohol abuse or dependence
* Participants with any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgment
* Participants having received non-pharmaceutical lower back pain treatment (physiotherapy, heat treatment or massage) within 12 hours prior to enrollment
* Participants having received spinal injection back pain treatment within 6 months prior to enrollment
* Participants having received surgery due to back pain or rehabilitation due to back pain in the last 12 months
* Participants with a known sensitivity to paracetamol
* Participants with known cutaneous hypersensitivity to plaster
* Participants participating in another clinical study within the past 30 days
* Participants who are pregnant or breastfeeding; contraception is mandatory
* Participants having damaged, non-intact, or scarred skin in or near the point of patch application
* Participants having a known skin sensitivity
* Participants having impaired blood circulation

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.