Phase 3 N=221 Randomized Treatment

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

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT05137041 ↗

Enrolled (actual)

221

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Percentage of Numerical Rating Scale (NRS) Responders at Day 5 — 72.5; 49.4 percentage of participants — p=0.002

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ITP FIRTECH (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sanofi
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Numerical Rating Scale (NRS) Responders at Day 5	72.5; 49.4	0.002 sig
SECONDARY Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs)	18; 7	—
SECONDARY Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5)	-1.52; -0.91	0.015 sig
SECONDARY Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score	-32.2; -16.4	0.103
SECONDARY Mobility Evaluation Using Schober's Test	7.9; 8.1; 8.7; 8.1; 0.9; -0.1	<0.001 sig
SECONDARY Mobility Evaluation Using Fingertip-to-Floor (FTF) Test	21.0; 18.6; 17.4; 17.5; -3.5; -1.7	0.121
SECONDARY Time to Reach Acceptable Pain	9.62; 8.65	0.564
SECONDARY Time to Reach no Pain	NA; NA	0.289
SECONDARY Time Course of PID	-0.8; -0.1; -1.1; -0.6; -1.3; -0.5	0.001 sig
SECONDARY Time Course of Pain Relief	0.8; 0.3; 1.2; 0.7; 1.2; 0.7	<0.001 sig
SECONDARY Normalized Sum of Pain Relief	1.46; 0.78	<0.001 sig

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05137041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.