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

Low Back Pain Clinical Trial

— IRPATCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05137041
• Other study ID #: LPS16453
• Secondary ID: U1111-1255-4648
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2021
• Est. completion date: November 22, 2022

Study information

• Verified date: December 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• ITP FIRTECH
Infrared Therapy Patch

Locations

Country	Name	City	State
Germany	Investigational Site Number :06	Bad Homburg
Germany	Investigational Site Number :02	Leipzig
Germany	Investigational Site Number :01	Munich
Germany	Investigational Site Number :03	Weinheim
Italy	Investigational Site Number :5	Alessandria
Italy	Investigational Site Number :4	Chieti
Italy	Investigational Site Number :7	Taormina	Messina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Numerical Rating Scale (NRS) responders at Day 5	NRS is used to assess pain intensity. Responder is defined as participant with =30% decrease from baseline in pain NRS and who did not take rescue medication	Baseline and Day 5
Secondary	Number of participants reported with adverse events	Number of participants reported with treatment-emergent adverse events (TEAEs)	Day 1 to Day 6
Secondary	Normalized Sum of Pain Intensity Difference (PID) over 5 days (SPID0-5)	PID equals the NRS change from baseline. A negative difference indicates improvement. Time-weighted summed pain intensity difference (SPID) was calculated by multiplying the PID score at each postdose time point by the duration since the preceding time point and then summing these values.	Baseline up to Day 5
Secondary	Percentage change in Roland-Morris Disability Questionnaire (RMDQ) score over 5 days	Self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale, with 1 point per question.	Baseline and Day 5
Secondary	Mobility evaluation	Change in mobility from baseline to Day 5 based on descriptive analysis using Schober's test or Fingertip-to-Floor test.	Baseline and Day 5
Secondary	Time to reach acceptable pain	Time to reach acceptable pain based on a NRS of 0 from baseline to Day 5	Up to Day 5
Secondary	Time to reach no pain	Time to reach no pain based on a NRS of 0 from baseline to Day 5	Up to Day 5
Secondary	Time course of PID	Time points for PID to be defined from baseline to Day 5	Baseline up to Day 5
Secondary	Time course of pain relief	Pain relief is assessed using a verbal rating scale, where 0 = none and 4 = complete in response to a pain relief question	Baseline up to Day 5
Secondary	Normalized sum of pain relief	Summed pain relief score (TOTPAR) calculated by multiplying the pain relief score at each postdose time point by the duration since the preceding time point and then summing these values. Higher scores indicate more pain relief.	Baseline up to Day 5