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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: ITP FIRTECH

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bad Homburg, Germany, 61348
    • Investigational Site Number :06
  • Leipzig, Germany, 04103
    • Investigational Site Number :02
  • Munich, Germany, 80809
    • Investigational Site Number :01
  • Weinheim, Germany, 69469
    • Investigational Site Number :03
• Italy
  • Alessandria, Italy, 15100
    • Investigational Site Number :5
  • Chieti, Italy, 66100
    • Investigational Site Number :4
  • Messina
    • Taormina, Messina, Italy, 98039
      • Investigational Site Number :7

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ITP FIRTECH; The ITP FIRTECH patch was applied on the lower back region of the body on Day 1 and intended to be worn for 5 Days (Day 5).	Device: ITP FIRTECH; Infrared Therapy Patch
No Intervention: No Patch Control Arm; No patch application.

What is the study measuring?

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, 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).	Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From Baseline to Day 5
Mobility Evaluation Using Schober's Test	Change in mobility from baseline to Day 5 using Schober's test score.Schober test consists of extending a tape measure on the spinal column, between two posterior superior iliac spines and up to 10 cm above this, with the individual in a neutral position. Then, participant is asked to do anterior flexion of the trunk, then therapist will measure the distance of the marked points, in participants without changes of mobility should increase at least 5 cm. Increases smaller than 5 cm indicate that the test is positive, decreased mobility of the lumbar spine. These data were collected at baseline and at Day 5 and then the change from baseline to Day 5 was calculated for each treatment group.This change from baseline is analyzed by Analysis of covariance(ANCOVA) model with the treatment group as fixed effect and baseline instantaneous pain NRS as continuous covariate.Score range for ITP FIRTECH arm is -2.0 to 6.0 and for no patch control arm is -4.2 to 2.0.	Baseline and Day 5
Mobility Evaluation Using Fingertip-to-Floor (FTF) Test	Change in mobility from baseline to Day 5 using FTF test score.Procedure for FTF test follow recommendation of American Psychological Association:participant stood erect on a platform 20-cm high with shoes removed and feet together.Participant was asked to bend forward as far as possible,while maintaining knees,arms,and fingers fully extended.Vertical distance between tip of middle finger and platform is measured with supple tape measure and is expressed in cm.Vertical distance between platform and tip of middle finger is positive when participant did not reach platform and negative when he could go further.These data were collected at baseline and at Day 5 and then change from baseline to Day 5 was calculated for each treatment group.This change from baseline is analyzed by ANCOVA model with treatment group as fixed effect and baseline instantaneous pain NRS as continuous covariate.Score range:ITP FIRTECH arm=-22.0-17.0;no patch control arm=-30.0-13.0.	Baseline and Day 5
Time to Reach Acceptable Pain	Time to reach acceptable pain is defined as the time in hours from baseline subject symptom self-assessment date and time (Day 1 Visit 1, Pain perception) to the first report of post-baseline acceptable pain.	Up to Day 5
Time to Reach no Pain	Time to reach no pain was defined as the time (hours) from baseline subject symptom self-assessment date and time (Day 1 Visit 1, Pain Perception) to the first report of instantaneous pain NRS=0.	Up to Day 5
Time Course of PID	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 was defined as instantaneous pain NRS change from baseline. Instantaneous pain NRS was analyzed from baseline up to Day 5. A negative difference indicates improvement.	Baseline up to Day 5
Time Course of Pain Relief	Pain relief is assessed using a verbal rating scale (VRS), where 0 = none and 4 = complete in response to a pain relief question.	Baseline up to Day 5
Normalized Sum of Pain Relief	Total pain relief (TOTPAR) is calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point. The Normalized Sum of Pain Relief (TOTPAR0- 5) is to be calculated as the Total Pain Relief divided by the total duration time. Higher scores indicate more pain relief. The score range is from 0.0 to 3.5 for both the arms.	Baseline up to Day 5

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

Helpful Links

• LPS16453 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): November 22, 2022
• Study Completion (Actual): November 22, 2022

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: LPS16453; U1111-1255-4648 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No