Low Back PainPhase 3IRPATCHNCT05137041
Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
A Phase 3 study testing ITP FIRTECH in people with Low Back Pain, run by Sanofi at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- ITP FIRTECH
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 4 Nov 2021to 22 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany4 sites
Investigational Site Number :06
Bad Homburg, 61348
Investigational Site Number :02
Leipzig, 04103
Investigational Site Number :01
Munich, 80809
Investigational Site Number :03
Weinheim, 69469
Italy3 sites
Investigational Site Number :5
Alessandria, 15100
Investigational Site Number :4
Chieti, 66100
Investigational Site Number :7
Taormina, Messina, 98039
About this study
Official title: 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
Read the detailed description
Duration of study participation is up to 6 days per participant.
- Conditions
- Low Back Pain
- Being tested
- ITP FIRTECH
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITP FIRTECHDevice
Infrared Therapy Patch
| Study group | Role | What they receive |
|---|---|---|
| ITP FIRTECH | Experimental | 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). Receives: Device: ITP FIRTECH |
| No Patch Control Arm | No intervention | No patch application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 5
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start4 Nov 2021
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137041
- Sponsor's protocol ID
- LPS16453
- Other IDs
- U1111-1255-4648
- Acronym
- IRPATCH
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2021
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05137041
- Acronym / sponsor ID
- IRPATCH / LPS16453
- Conditions
- Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Duration of study participation is up to 6 days per participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITP FIRTECH | Experimental | Device: ITP FIRTECHThe 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). |
| No Patch Control Arm | No intervention | –No patch application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITP FIRTECHInfrared Therapy Patch | Device | ITP FIRTECH |
Primary outcome
Percentage of Numerical Rating Scale (NRS) Responders at Day 5
Time frame: 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).
10 secondary outcomes
Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 6
Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5)
Time frame: Baseline, Day 5
Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score
Time frame: From Baseline to Day 5
Mobility Evaluation Using Schober's Test
Time frame: Baseline and Day 5
Mobility Evaluation Using Fingertip-to-Floor (FTF) Test
Time frame: Baseline and Day 5
Time to Reach Acceptable Pain
Time frame: Up to Day 5
Time to Reach no Pain
Time frame: Up to Day 5
Time Course of PID
Time frame: Baseline up to Day 5
Time Course of Pain Relief
Time frame: Baseline up to Day 5
Normalized Sum of Pain Relief
Time frame: Baseline up to Day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- LPS16453 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ITP FIRTECH in people with Low Back Pain, run by Sanofi at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Numerical Rating Scale (NRS) Responders at Day 5 (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.