Clinical trial NCT05137041: Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-11-30
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

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.

Primary outcomes:
measure: Percentage of Numerical Rating Scale (NRS) Responders at Day 5
timeFrame: Day 5
Secondary outcomes:
measure: Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 6
measure: Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5)
timeFrame: Baseline, Day 5
measure: Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score
timeFrame: From Baseline to Day 5
measure: Mobility Evaluation Using Schober's Test
timeFrame: Baseline and Day 5
measure: Mobility Evaluation Using Fingertip-to-Floor (FTF) Test
timeFrame: Baseline and Day 5
measure: Time to Reach Acceptable Pain
timeFrame: Up to Day 5
measure: Time to Reach no Pain
timeFrame: Up to Day 5
measure: Time Course of PID
timeFrame: Baseline up to Day 5
measure: Time Course of Pain Relief
timeFrame: Baseline up to Day 5
measure: Normalized Sum of Pain Relief
timeFrame: Baseline up to Day 5
Other outcomes:
Locations:
city: Bad Homburg
country: Germany
facility: Investigational Site Number :06
city: Leipzig
country: Germany
facility: Investigational Site Number :02
city: Munich
country: Germany
facility: Investigational Site Number :01
city: Weinheim
country: Germany
facility: Investigational Site Number :03
city: Taormina
country: Italy
facility: Investigational Site Number :7
state: Messina
city: Alessandria
country: Italy
facility: Investigational Site Number :5
city: Chieti
country: Italy
facility: Investigational Site Number :4
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: