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

Study Overview
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Brief Summary
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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

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

Official Title
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A Phase IIIB Randomized, Open Label, Two Arms and Parallel Group Clinical Trial to Assess the Efficacy and Safety of FIRTECH (Infrared Therapy Patch), for Treating Patients Suffering From Mild to Moderate Acute Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: ITP FIRTECH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITP FIRTECH<br>ITP FIRTECH patch will be applied and remain in position for 5 days | Device: ITP FIRTECH<br>* Infrared Therapy Patch<br>|
| No Intervention: No Patch Control Arm<br>No patch application | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Numerical Rating Scale (NRS) responders at Day 5 | NRS is used to assess pain intensity. Responder is defined as participant with ≥30% decrease from baseline in pain NRS and who did not take rescue medication | Baseline and Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reported with adverse events | Number of participants reported with treatment-emergent adverse events (TEAEs) | Day 1 to Day 6 | 
| Normalized Sum of Pain Intensity Difference (PID) over 5 days (SPID0-5) | PID equals the NRS change from baseline. A negative difference indicates improvement. Time-weighted summed pain intensity difference (SPID) was calculated by multiplying the PID score at each postdose time point by the duration since the preceding time point and then summing these values. | Baseline up to Day 5 | 
| Percentage change in Roland-Morris Disability Questionnaire (RMDQ) score over 5 days | Self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale, with 1 point per question. | Baseline and Day 5 | 
| Mobility evaluation | Change in mobility from baseline to Day 5 based on descriptive analysis using Schober's test or Fingertip-to-Floor test. | Baseline and Day 5 | 
| Time to reach acceptable pain | Time to reach acceptable pain based on a NRS of 0 from baseline to Day 5 | Up to Day 5 | 
| Time to reach no pain | Time to reach no pain based on a NRS of 0 from baseline to Day 5 | Up to Day 5 | 
| Time course of PID | Time points for PID to be defined from baseline to Day 5 | Baseline up to Day 5 | 
| Time course of pain relief | Pain relief is assessed using a verbal rating scale, where 0 = none and 4 = complete in response to a pain relief question | Baseline up to Day 5 | 
| Normalized sum of pain relief | Summed pain relief score (TOTPAR) calculated by multiplying the pain relief score at each postdose time point by the duration since the preceding time point and then summing these values. Higher scores indicate more pain relief. | Baseline up to Day 5 |