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| Name | Class |
|---|---|
| Monash University | OTHER |
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The objective of this Investigator Initiated study is to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in participants experiencing pain, reducing pain during movement. This study is an intervention trial on two discrete subject samples; (1) people with recent back pain, and (2) people who regularly play sport. ViMove wearable sensors provide precise objective measurements of low back muscle activity and movement in real time and can capture a patient's reporting of pain during movement. Outcomes will be assessed through standard ViMove protocols in conjunction with multiple validated measures of pain, perception of change, and function.
This investigator-initiated study will utilize a prospective open-label study design to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in participants experiencing pain, reducing pain during movement. Two discrete subject samples will be enrolled; (1) people with recent back pain, and (2) people who regularly play sport. Both samples will be enrolled using respective criteria.
Following enrollment, both subject groups will have a "start interview" on their allocated baseline assessment day (Day 1). This will include fitting of the ViMove movement and EMG sensors, as well as a live "pain on movement" assessment. This session will take approximately 20-30 minutes. Whilst wearing the ViMove sensors, subjects will then leave the clinic and conduct normal daily activities for a pre-determined monitoring period. No ThermaCare HeatWraps are worn on Day 1. This allows a baseline assessment and allows any placebo effects from the sensors to be discounted. At the end of the monitoring session, subjects will return to the clinic to have an "end-of-day" interview. Clinicians will administer the Oswestry Disability Index (ODI), the Visual Analogue Scale for Pain (VAS Pain), and the Patient Global Impression of Change scale (PGIC). ViMove movement sensors will then be removed, and the subject will be reimbursed for that day.
The intervention day (Day 2) will have the same procedure as Day 1 (baseline), with the only difference being the additional application of ThermaCare HeatWraps during the "start interview". Subjects will continue to wear the HeatWrap and ViMove sensors during the 8-hour daily activity monitoring period, with the wrap and sensors being removed during the end-of-day interview. The subject will then be reimbursed for Day 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Back Pain Group | Experimental | Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. |
|
| Active in Sport Group | Experimental | Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ThermaCare Low Back Heat Wrap | Device | The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Movement Data Over Time | Collection of movement data from all participants. The results listed here depict the average change in Trunk Range of Motion (ROM) between day 1 and day 2 PM sessions | Change from Baseline movement data after 1 consecutive day. |
| Change in Erector Spinae Muscle Activity Over Time | Collection of erector spinae muscle activity data from all participants. The results provided depict the mean muscle-activity difference between the day 1 and day 2 PM sessions. Surface Electromyography (sEMG) sensors are adhered utilizing a height-specific sensor placement template. Placement is parallel with the L3 vertebrae. Evaluated in the form of the flexion-relaxation response. When performing a forward flexion movement, muscle activation occurs at the commencement of the movement (when bending down;concentric), as well as during the return to the upright position (eccentric). At maximum flexion, minimal muscle activation is expected (i.e. muscle relaxation). However, in subjects with Low-back pain, muscle relaxation is often absent. As such, the following formula is used to evaluate the flexion-relaxation response. Sum of sEMG activity at maximum flexion divided by the summed sEMG activity of both concentric and eccentric muscle activation. | Change from Baseline Erector spinae muscle activity data after 1 consecutive day. |
| Measure | Description | Time Frame |
|---|---|---|
| A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion. | Maximal range of low back movement in sagittal,axial and coronal planes. Results depict the change in Pelvis ROM in the sagittal plane. | Change from Baseline after 1 consecutive day. |
| In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement. |
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Inclusion criteria for recent low back pain patients (Group 1):
Inclusion criteria for people who are active in sports (Group 2):
Exclusion Criteria (applies to both Groups):
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Ronchi, PhD | dorsaVi Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clifton Hill Physiotherapy | Clifton Hill | Victoria | 3068 | Australia | ||
| Peak MSK Physiotherapy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Back Pain Group | Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
| FG001 | Active in Sport Group | Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility and muscle relaxation. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Back Pain Group | Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Movement Data Over Time | Collection of movement data from all participants. The results listed here depict the average change in Trunk Range of Motion (ROM) between day 1 and day 2 PM sessions | Posted | Mean | Standard Deviation | Degrees | Change from Baseline movement data after 1 consecutive day. |
|
From the 10th July 2017 to the 23rd December 2017. This is from the first assessment date, to two days after the final assessment date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Back Pain Group | Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sangeeth Wanasinghage | dorsaVi Ltd | +61 1800 367 728 | support@dorsavi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 29, 2017 | Feb 6, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2017 | Feb 6, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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The two study groups (LBP group vs. Active in spot group), will receive the same intervention in the same order (i.e. Baseline day with no intervention, then intervention day with ThermaCare intervention).
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This study is open label, meaning that no masking occurs
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Pain Score out of 10 as rated on the ViMove scale during movement assessment. Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in pain scores between baseline and post-intervention |
| Change from Baseline after 1 consecutive day. |
| A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected. | Surface EMG measurement of erector spinae muscle activity at L3 vertebra level | Change from Baseline after 1 consecutive day. |
| Change in Pain From Baseline | Pain Score out of 10 as measured on a Numeric Rating scale (NRS) Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in NRS scores between baseline and post-intervention | Change from Baseline after 1 consecutive day. |
| Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Oswestry Disability Index (ODI) if Subjects Scored >3 on the NRS | Measurement of disability related to low back pain. Contains 10 sections, each of which can be from from 0-5 for a maximum score of 50. 50 indicates maximum possible disability (bed-bound - or are exaggerating their symptoms). The results depicted indicate the change in NRS scores between baseline and post-intervention | Change from Baseline after 1 consecutive day. |
| Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC). | Measurement of perceived change in Low back pain. Score from a scale of 1-7. 1 indicates no change (or condition has worsened), 7 indicates a considerable improvement. The results depicted indicate the change in PGIC scores between Day 1 and Day 2 (intervention) | Change from Baseline after 1 consecutive day. |
| Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Roland Morris Disability Questionnaire (RMDQ) if Subjects Scored >3 on the NRS | Measurement of disability related to low back pain. A checklist of 24 items. A score of 24 indicates maximum disability. | Change from Baseline after 1 consecutive day. |
| Hampton |
| Victoria |
| 3188 |
| Australia |
| Hoppers Physio | Hoppers Crossing | Victoria | 3168 | Australia |
| BG001 | Active in Sport Group | Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Active in Sport Group | Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. |
|
|
| Primary | Change in Erector Spinae Muscle Activity Over Time | Collection of erector spinae muscle activity data from all participants. The results provided depict the mean muscle-activity difference between the day 1 and day 2 PM sessions. Surface Electromyography (sEMG) sensors are adhered utilizing a height-specific sensor placement template. Placement is parallel with the L3 vertebrae. Evaluated in the form of the flexion-relaxation response. When performing a forward flexion movement, muscle activation occurs at the commencement of the movement (when bending down;concentric), as well as during the return to the upright position (eccentric). At maximum flexion, minimal muscle activation is expected (i.e. muscle relaxation). However, in subjects with Low-back pain, muscle relaxation is often absent. As such, the following formula is used to evaluate the flexion-relaxation response. Sum of sEMG activity at maximum flexion divided by the summed sEMG activity of both concentric and eccentric muscle activation. | Posted | Mean | Standard Deviation | Ratio | Change from Baseline Erector spinae muscle activity data after 1 consecutive day. |
|
|
|
| Secondary | A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion. | Maximal range of low back movement in sagittal,axial and coronal planes. Results depict the change in Pelvis ROM in the sagittal plane. | Posted | Mean | Standard Deviation | Degrees | Change from Baseline after 1 consecutive day. |
|
|
|
| Secondary | In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement. | Pain Score out of 10 as rated on the ViMove scale during movement assessment. Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in pain scores between baseline and post-intervention | Pain scores were not captured for the sports group as 'no pain' is a selection criterion for this group. | Posted | Mean | Standard Error | score on a scale | Change from Baseline after 1 consecutive day. |
|
|
|
| Secondary | A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected. | Surface EMG measurement of erector spinae muscle activity at L3 vertebra level | Posted | Mean | Standard Deviation | Ratio | Change from Baseline after 1 consecutive day. |
|
|
|
| Secondary | Change in Pain From Baseline | Pain Score out of 10 as measured on a Numeric Rating scale (NRS) Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in NRS scores between baseline and post-intervention | Pain scores were not captured for the sports group as 'no pain' is a selection criterion for this group. | Posted | Mean | Standard Error | scale on a scale | Change from Baseline after 1 consecutive day. |
|
|
|
| Secondary | Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Oswestry Disability Index (ODI) if Subjects Scored >3 on the NRS | Measurement of disability related to low back pain. Contains 10 sections, each of which can be from from 0-5 for a maximum score of 50. 50 indicates maximum possible disability (bed-bound - or are exaggerating their symptoms). The results depicted indicate the change in NRS scores between baseline and post-intervention | ODI scores were not captured for the sports group as 'no pain/disability' is a selection criterion for this group. | Posted | Mean | Standard Error | score on a scale | Change from Baseline after 1 consecutive day. |
|
|
|
| Secondary | Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC). | Measurement of perceived change in Low back pain. Score from a scale of 1-7. 1 indicates no change (or condition has worsened), 7 indicates a considerable improvement. The results depicted indicate the change in PGIC scores between Day 1 and Day 2 (intervention) | PGIC data were not collected for the Active in Sport Group, as subjects in this group were selected on the basis that they had no pain. As such, they would not have had an applicable impression of change related to pain. | Posted | Mean | Standard Error | score on a scale | Change from Baseline after 1 consecutive day. |
|
|
|
| Secondary | Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Roland Morris Disability Questionnaire (RMDQ) if Subjects Scored >3 on the NRS | Measurement of disability related to low back pain. A checklist of 24 items. A score of 24 indicates maximum disability. | RMDQ scores were not captured for the sports group as 'no pain/disability' is a selection criterion for this group. | Posted | Mean | Standard Error | score on a scale | Change from Baseline after 1 consecutive day. |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Active in Sport Group | Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain. The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day. ThermaCare Low Back Heat Wrap: The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |