Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1255-4648 | Registry Identifier | ICTRP |
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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:
Duration of study participation is up to 6 days per participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITP FIRTECH | Experimental | 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). |
|
| No Patch Control Arm | No Intervention | No patch application. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITP FIRTECH | Device | Infrared Therapy Patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 6 |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :06 | Bad Homburg | 61348 | Germany | |||
| Investigational Site Number :02 |
Not provided
| Label | URL |
|---|---|
| LPS16453 Plain Language Results Summary | View source |
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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
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Participants suffering from mild to moderate acute low back pain were randomly assigned in a 1:1 ratio to receive either FIRTECH patch or no patch.
A total of 221 participants took part in the study at 7 investigative sites in Germany and Italy from 04 November 2021 to 22 November 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ITP FIRTECH | The infrared therapy patch (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). |
| FG001 | No Patch Control Arm | No patch application. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat population was defined as all participants randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | No Patch Control Arm | No patch application. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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"). | Posted | Number | 95% Confidence Interval | percentage of participants | Day 5 |
|
Day 1 to Day 6
All-Cause Mortality, Serious Adverse Events and Other (Not Including Serious) Adverse Events is mentioned for Safety Population. Safety population was defined as all participants randomized into the study and, if randomized to the "patch" arm, had the device installed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDra 24.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2022 | Oct 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2022 | Oct 26, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
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| 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. | Baseline, Day 5 |
| 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. | From Baseline to Day 5 |
| 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. | Baseline and Day 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. | Baseline and Day 5 |
| 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. | Up to Day 5 |
| 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. | Up to Day 5 |
| 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. | Baseline up to Day 5 |
| 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. | Baseline up to Day 5 |
| 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. | Baseline up to Day 5 |
| Leipzig |
| 04103 |
| Germany |
| Investigational Site Number :01 | Munich | 80809 | Germany |
| Investigational Site Number :03 | Weinheim | 69469 | Germany |
| Investigational Site Number :7 | Taormina | Messina | 98039 | Italy |
| Investigational Site Number :5 | Alessandria | 15100 | Italy |
| Investigational Site Number :4 | Chieti | 66100 | Italy |
| Reason not Specified |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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). |
| OG001 | No Patch Control Arm | No patch application. |
|
|
|
| Secondary | 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. | Safety population was defined as all participants randomized into the study and, if randomized to the "patch" arm, had the device installed. | Posted | Count of Participants | Participants | Day 1 to Day 6 |
|
|
|
| Secondary | 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. | 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"). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 5 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percentage change in RMDQ score | From Baseline to Day 5 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | cm | Baseline and Day 5 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | cm | Baseline and Day 5 |
|
|
|
|
| Secondary | 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. | 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"). | Posted | Median | 95% Confidence Interval | hours | Up to Day 5 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Median | 95% Confidence Interval | hours | Up to Day 5 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline up to Day 5 |
|
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline up to Day 5 |
|
|
|
|
| Secondary | 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. | 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"). | Posted | Mean | Standard Deviation | units on a scale | Baseline up to Day 5 |
|
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 18 |
| 114 |
| EG001 | No Patch Control Arm | No patch application. | 0 | 107 | 0 | 107 | 7 | 107 |
| Application Site Erythema | General disorders | MedDra 24.1 | Systematic Assessment |
|
| Application Site Irritation | General disorders | MedDra 24.1 | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDra 24.1 | Systematic Assessment |
|
| Application Site Paraesthesia | General disorders | MedDra 24.1 | Systematic Assessment |
|
| Application Site Pruritus | General disorders | MedDra 24.1 | Systematic Assessment |
|
| Gastrointestinal Infection | Infections and infestations | MedDra 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDra 24.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDra 24.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDra 24.1 | Systematic Assessment |
|
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDra 24.1 | Systematic Assessment |
|
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDra 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra 24.1 | Systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDra 24.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDra 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 24.1 | Systematic Assessment |
|
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Day 5 |
|
|
| Change from Baseline |
|
|
| Day 5 |
|
|
| Change from Baseline |
|
|
| Change from Baseline at Day 2 Morning |
|
|
| Change from Baseline at Day 2 Evening |
|
|
| Change from Baseline at Day 3 Morning |
|
|
| Change from Baseline at Day 3 Evening |
|
|
| Change from Baseline at Day 4 Morning |
|
|
| Change from Baseline at Day 4 Evening |
|
|
| Change from Baseline at Day 5 Morning |
|
|
| Change from Baseline at Day 5 |
|
|
| 0.035 |
| Superiority |
| Change from Baseline at Day 2 Evening | Satterthwaite t-test | 0.004 | Superiority |
| Change from Baseline at Day 3 Morning | Satterthwaite t-test | 0.007 | Superiority |
| Change from Baseline at Day 3 Evening | Satterthwaite t-test | 0.005 | Superiority |
| Change from Baseline at Day 4 Morning | Satterthwaite t-test | 0.001 | Superiority |
| Change from Baseline at Day 4 Evening | Satterthwaite t-test | 0.007 | Superiority |
| Change from Baseline at Day 5 Morning | Satterthwaite t-test | 0.096 | Superiority |
| Change from Baseline at Day 5 | Satterthwaite t-test | 0.015 | Superiority |
| Day 2 Morning |
|
|
| Day 2 Evening |
|
|
| Day 3 Morning |
|
|
| Day 3 Evening |
|
|
| Day 4 Morning |
|
|
| Day 4 Evening |
|
|
| Day 5 Morning |
|
|
| Day 5 |
|
|
| 0.001 |
| Superiority |
| VRS: Day 2 Evening | Satterthwaite t-test | <0.001 | Superiority |
| VRS: Day 3 Morning | Satterthwaite t-test | <0.001 | Superiority |
| VRS: Day 3 Evening | Satterthwaite t-test | <0.001 | Superiority |
| VRS: Day 4 Morning | Satterthwaite t-test | <0.001 | Superiority |
| VRS: Day 4 Evening | Satterthwaite t-test | <0.001 | Superiority |
| VRS: Day 5 Morning | Satterthwaite t-test | 0.024 | Superiority |
| VRS: Day 5 | Satterthwaite t-test | <0.001 | Superiority |