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

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• Low Back Pain 2,818

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 221 is above the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Study arms

• Experimental
  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).

  Device: ITP FIRTECH

• No intervention
  No Patch Control Arm

  No patch application.

Interventions

• DeviceITP FIRTECH

  Infrared Therapy Patch

Primary outcomes

1. Percentage of Numerical Rating Scale (NRS) Responders at 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).

   Time frame: Day 5

Secondary outcomes

1. Number of Participants Reported With Treatment Emergent Adverse Events (TEAEs)

   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

2. Normalized Sum of Pain Intensity Difference (PID) Over 5 Days (SPID0-5)

   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.

   Time frame: Baseline, Day 5

3. Percentage Change in Roland-Morris Disability Questionnaire (RMDQ) Score

   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

4. Mobility Evaluation Using Schober's Test

   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

5. Mobility Evaluation Using Fingertip-to-Floor (FTF) Test

   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

6. Time to Reach Acceptable Pain

   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

7. Time to Reach no Pain

   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

8. Time Course of PID

   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

9. Time Course of Pain Relief

   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

10. Normalized Sum of Pain Relief

    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

Baseline characteristics

Related links

• LPS16453 Plain Language Results Summary ↗

Study documents

• Study protocol · Jul 22, 2022
• Statistical analysis plan · Dec 12, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org