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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Device: ITP FIRTECH

Study type: Interventional

Funder types: Industry

Identifiers

NCT05137041

LPS16453

U1111-1255-4648 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment: 221 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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221 participants in 2 patient groups

ITP FIRTECH

Experimental group

Description:

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).

Treatment:

Device: ITP FIRTECH

No Patch Control Arm

No Intervention group

Description:

No patch application.