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

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    200
  • sponsor
    Sanofi
Updated on 7 July 2022
back pain
low back pain
pain in the lumbar spine

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

Description

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

Details
Condition Low Back Pain
Treatment ITP FIRTECH, No Patch
Clinical Study IdentifierNCT05137041
SponsorSanofi
Last Modified on7 July 2022

Eligibility

Yes No Not Sure

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 first pain episode in participant's life, or after a pain-free interval of at least six months, and lasts no longer than six weeks -With intensity ≤ 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 experiencing work litigation, anxiety and/or depression
Participants taking any medication for their pain within the last 5 days (only accepted up to 2 g of paracetamol per day)
Participants having received any therapy (medication or patches) for their pain within the last 5 days
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
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