Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Device: ITP FIRTECH
- Registration Number
- NCT05137041
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ITP FIRTECH ITP FIRTECH 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).
- Primary Outcome Measures
Name Time Method Percentage of Numerical Rating Scale (NRS) Responders at Day 5 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).
- Secondary Outcome Measures
Name Time Method Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs) Day 1 to Day 6 An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A treatment emergent adverse event (TEAE) is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.
Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5) Baseline, 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'. 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. The Normalized Sum of Pain Intensity Difference (SPID0- 5) is to be calculated as the SPID0- 5 divided by the total duration time. The score range for ITP FIRTECH arm is -5.0 to 2.1 and for no patch control arm is -5.8 to 3.1.
Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score From Baseline to Day 5 The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.
Mobility Evaluation Using Schober's Test Baseline and Day 5 Change in mobility from baseline to Day 5 using Schober's test score.Schober test consists of extending a tape measure on the spinal column, between two posterior superior iliac spines and up to 10 cm above this, with the individual in a neutral position. Then, participant is asked to do anterior flexion of the trunk, then therapist will measure the distance of the marked points, in participants without changes of mobility should increase at least 5 cm. Increases smaller than 5 cm indicate that the test is positive, decreased mobility of the lumbar spine. These data were collected at baseline and at Day 5 and then the change from baseline to Day 5 was calculated for each treatment group.This change from baseline is analyzed by Analysis of covariance(ANCOVA) model with the treatment group as fixed effect and baseline instantaneous pain NRS as continuous covariate.Score range for ITP FIRTECH arm is -2.0 to 6.0 and for no patch control arm is -4.2 to 2.0.
Mobility Evaluation Using Fingertip-to-Floor (FTF) Test Baseline and Day 5 Change in mobility from baseline to Day 5 using FTF test score.Procedure for FTF test follow recommendation of American Psychological Association:participant stood erect on a platform 20-cm high with shoes removed and feet together.Participant was asked to bend forward as far as possible,while maintaining knees,arms,and fingers fully extended.Vertical distance between tip of middle finger and platform is measured with supple tape measure and is expressed in cm.Vertical distance between platform and tip of middle finger is positive when participant did not reach platform and negative when he could go further.These data were collected at baseline and at Day 5 and then change from baseline to Day 5 was calculated for each treatment group.This change from baseline is analyzed by ANCOVA model with treatment group as fixed effect and baseline instantaneous pain NRS as continuous covariate.Score range:ITP FIRTECH arm=-22.0-17.0;no patch control arm=-30.0-13.0.
Time to Reach Acceptable Pain Up to Day 5 Time to reach acceptable pain is defined as the time in hours from baseline subject symptom self-assessment date and time (Day 1 Visit 1, Pain perception) to the first report of post-baseline acceptable pain.
Time to Reach no Pain Up to Day 5 Time to reach no pain was defined as the time (hours) from baseline subject symptom self-assessment date and time (Day 1 Visit
1, Pain Perception) to the first report of instantaneous pain NRS=0.Time Course of PID Baseline up to 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'. PID was defined as instantaneous pain NRS change from baseline. Instantaneous pain NRS was analyzed from baseline up to Day 5. A negative difference indicates improvement.
Time Course of Pain Relief Baseline up to Day 5 Pain relief is assessed using a verbal rating scale (VRS), where 0 = none and 4 = complete in response to a pain relief question.
Normalized Sum of Pain Relief Baseline up to Day 5 Total pain relief (TOTPAR) is calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point. The Normalized Sum of Pain Relief (TOTPAR0- 5) is to be calculated as the Total Pain Relief divided by the total duration time. Higher scores indicate more pain relief. The score range is from 0.0 to 3.5 for both the arms.
Trial Locations
- Locations (7)
Investigational Site Number :5
🇮🇹Alessandria, Italy
Investigational Site Number :01
🇩🇪Munich, Germany
Investigational Site Number :7
🇮🇹Taormina, Messina, Italy
Investigational Site Number :06
🇩🇪Bad Homburg, Germany
Investigational Site Number :03
🇩🇪Weinheim, Germany
Investigational Site Number :02
🇩🇪Leipzig, Germany
Investigational Site Number :4
🇮🇹Chieti, Italy