efficacy and safety of firtech in patients with mild to moderate acute low back pain

Conditions: Low Back Pain

Summary: 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.