Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain (NCT05137041) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
Germany, Italy221 participantsStarted 2021-11-04
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Percentage of Numerical Rating Scale (NRS) Responders at Day 5