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

NCT05137041 | Completed Phase 3 Results

• 2 other identifiers: LPS16453U1111-1255-4648
• Study Type: interventional
• Target: 221
• Locations: 2 countries
• Sites: 7

Brief 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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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)

  Baseline, Day 5

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

  From Baseline to Day 5

• Mobility Evaluation Using Schober's Test

  Baseline and Day 5

• Mobility Evaluation Using Fingertip-to-Floor (FTF) Test

  Baseline and Day 5

Study Arms (2)

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).

Device: ITP FIRTECH

No Patch Control Arm

NO INTERVENTION

No patch application.

Interventions

ITP FIRTECH DEVICE

Infrared Therapy Patch

ITP FIRTECH

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Investigational Site Number :06

Bad Homburg, 61348, Germany

Location

Investigational Site Number :02

Leipzig, 04103, Germany

Location

Investigational Site Number :01

Munich, 80809, Germany

Location

Investigational Site Number :03

Weinheim, 69469, Germany

Location

Investigational Site Number :7

Taormina, Messina, 98039, Italy

Location

Investigational Site Number :5

Alessandria, 15100, Italy

Location

Investigational Site Number :4

Chieti, 66100, Italy

Location

Related Links

• LPS16453 Plain Language Results Summary

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: November 30, 2021
• Study Start: November 4, 2021
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: September 9, 2025
• Results First Posted: September 19, 2024

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (4); IT (3)