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

Sanofi221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

221

Conditions

Low Back Pain

Interventions

ITP FIRTECHDEVICE

Infrared Therapy Patch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (7)

Investigational Site Number :06

Bad Homburg, Germany

Investigational Site Number :02

Leipzig, Germany

Investigational Site Number :01

Munich, Germany

Investigational Site Number :03

Weinheim, Germany

Outcomes

Primary Outcomes

Percentage of Numerical Rating Scale (NRS) Responders at Day 5

NRS is used to assess pain intensity, it is a 11-point scale (0-10) where '0' representing 'no pain' and '10' representing 'worst pain imaginable'. Responder is defined as participant with ≥30% decrease from baseline in pain NRS and who did not take rescue medication (defined as receiving paracetamol (authorized), any other analgesics and anti-inflammatory drugs as well as any non-pharmaceutical therapy (prohibited) for treating pain starting from randomization to Day 5 or starting before the study and still ongoing at randomization).

Time frame: Day 5

Secondary Outcomes

Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A treatment emergent adverse event (TEAE) is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.

Time frame: Day 1 to Day 6

Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5)

NRS is used to assess pain intensity, it is a 11-point scale (0-10) where '0' representing 'no pain' and '10' representing 'worst pain imaginable'. 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. The Normalized Sum of Pain Intensity Difference (SPID0- 5) is to be calculated as the SPID0- 5 divided by the total duration time. The score range for ITP FIRTECH arm is -5.0 to 2.1 and for no patch control arm is -5.8 to 3.1.

Time frame: Baseline, Day 5

Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score

The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.

Data from ClinicalTrials.gov

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