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

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).

Time frame: Day 5

Population: Modified Intent-to-Treat population was defined as all participants randomized that had the Numerical Rating Scale (NRS) evaluation done at baseline and Day 5 with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0).

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 frame: Baseline and Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0). Number analyzed is the number of participants with data available for analysis at specific timepoint.

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.

Time frame: Baseline and Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0). Number analyzed is the number of participants with data available for analysis at specific timepoint.

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.

Time frame: Baseline, Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0).

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.

Time frame: Baseline up to Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0).

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.

Time frame: Day 1 to Day 6

Population: Safety population was defined as all participants randomized into the study and, if randomized to the patch arm, had the device installed.

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.

Time frame: From Baseline to Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0). Overall number analyzed is the number of participants with data available for analysis.

Pain relief is assessed using a verbal rating scale (VRS), where 0 = none and 4 = complete in response to a pain relief question.

Time frame: Baseline up to Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0). Number analyzed is the number of participants with data available at specific timepoint.

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 frame: Baseline up to Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0). Number analyzed is the number of participants with data available for analysis at specific timepoints.

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 frame: Up to Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0).

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 frame: Up to Day 5

Population: Full Analysis Set population was defined as all participants randomized that had the NRS evaluation done at baseline and that were not using any rescue medication starting from randomization to Day 5 Visit 2 or starting before the study and still ongoing at randomization with the exclusion of participants without any pain at baseline (i.e. baseline instantaneous pain NRS score equal to 0). Overall number analyzed is the number of censored participants with the event.