A Prospective Open Label Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain in Two Different Populations
Phase: NA
Conditions: Low Back Pain
Sponsor: dorsaVi Ltd

A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle 
relaxation & low back pain in two different populations. 
 
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A Prospective Open Label pilot study investigating the 
impact of ThermaCare on flexibility, muscle relaxation & 
low back pain in two different populations. 
This investigational protocol contains confidential information for use by the principal investigator and 
their designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. It should not be copied or made available for review 
by any unauthorized person or firm. 
 
 

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Table of Contents 
PROTOCOL SUMMARY ............................................................................................................................ 5 
1: 
INTRODUCTION ............................................................................................................................... 7 
2: 
BACKGROUND ................................................................................................................................. 7 
3: 
AIMS, HYPOTHESES, AND OBJECTIVES ............................................................................................ 9 
3.1 Aims ........................................................................................................................................... 9 
3.2 Hypotheses ................................................................................................................................ 9 
3.3 Objectives .................................................................................................................................. 9 
4: 
STUDY DESIGN ................................................................................................................................. 9 
5: 
STUDY SETTING/LOCATIONS ......................................................................................................... 10 
6: 
STUDY POPULATION ...................................................................................................................... 10 
7: 
ELIGIBILITY CRITERIA ..................................................................................................................... 10 
7.1 Inclusion Criteria ..................................................................................................................... 10 
7.1.1 Inclusion Criteria for Low Back Pain Patients: ......................................................... 10 
7.1.2 Inclusion Criteria for Active in Sport: ...................................................................... 10 
7.2 Exclusion Criteria ..................................................................................................................... 11 
7.3 Withdrawal Criteria ................................................................................................................. 11 
8: 
STUDY PROCEDURES ..................................................................................................................... 11 
8.1 Recruitment of Subjects .......................................................................................................... 11 
8.2 Randomization ........................................................................................................................ 11 
8.3 Study Protocols ....................................................................................................................... 12 
8.3.1 Guidelines for Scheduling Subjects’ Clinic Visits ..................................................... 12 
8.3.2 Study Personnel Training ......................................................................................... 12 
8.4 Methodology ........................................................................................................................... 12 
8.5 Measurement Tools Used ....................................................................................................... 15 
8.5.1 ViMove – Range of Movement and Surface Muscle Activity .................................. 15 
8.5.2 ViMove – Pain on movement .................................................................................. 15 
8.5.3 ViMove – Monitoring (Out-of-clinic Assessment) ................................................... 15 
8.5.4 Questionnaires ........................................................................................................ 15 
9: 
ANTICIPATED BENEFITS AND RISKS ............................................................................................... 16 
9.1 Potential Benefits .................................................................................................................... 16 
9.2 Potential Risks ......................................................................................................................... 16 
9.2.1 Risk Minimization .................................................................................................... 17 
10: SAFETY CONSIDERATIONS ............................................................................................................. 18 
10.1 Documentation and Reporting of Adverse Events ................................................................ 18 

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10.2 Documentation and Reporting of Serious Adverse Events ................................................... 20 
10.3 Device-Related Observations (DROs) .................................................................................... 21 
11: STATISICAL CONSIDERATIONS AND DATA ANALYSIS .................................................................... 21 
11.1 Sample Size and Statistical Power ......................................................................................... 21 
11.2 Statistical Methods ................................................................................................................ 21 
12: ETHICS CONSIDERATIONS ............................................................................................................. 22 
12.1 Quality Assurance .................................................................................................................. 22 
12.2 Confidentiality of Study Data ................................................................................................ 23 
12.2.1 Case Report Forms ................................................................................................ 23 
12.2.2 Source Documents ................................................................................................ 24 
13: STUDY OUTCOMES AND SIGNIFICANCE ........................................................................................ 24 
13.1 Primary Endpoints ................................................................................................................. 24 
13.2 Secondary Endpoints ............................................................................................................. 24 
13.3 Significance ............................................................................................................................ 24 
14: REFERENCES .................................................................................................................................. 25 
 
 
 

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A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle 
relaxation & low back pain in two different populations. 
 
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PROTOCOL SUMMARY 
Title: 
A Prospective Open Label pilot study investigating the impact of ThermaCare 
on flexibility, muscle relaxation & low back pain in two different populations. 
Device(s): 
The devices to be used for this study include:  
• 
ThermaCare Lower Back HeatWraps, Pfizer Consumer Healthcare 
• 
ViMove wearable sensors, dorsaVi Ltd. 
Study Objective: 
The objectives of this study are to evaluate the impact of ThermaCare 
HeatWraps as an intervention to: 
1. Decrease pain during movement, improve muscle relaxation and increase 
flexibility in people with low back pain (Group 1). 
2. Improve muscle relaxation and increase flexibility in people who are 
actively involved in sport (Group 2). 
Study Design: 
This research will utilize a prospective open-label investigator initiated study 
design. This allows the assessment of ThermaCare HeatWrap efficacy pre- and 
post- application, and may provide insight into the mechanisms of any 
observed pain relief. The nature of the ThermaCare intervention means that 
blinding is difficult, as there is no adequate placebo heat therapy.  
Enrolment Size: 
The enrolment size will be 40 total subjects from 2 discrete population groups. 
As we expect an attrition rate of 20%, we will initially recruit 50 subjects. 
Subject 
Population: 
As per the inclusion and exclusion criteria: 
Group 1: 20 people with recent back pain  
Group 2: 20 people who regularly play sport  
Timeframe: 
We expect 6-months will be required from first participant enrolment to the 
last participant visit. A further 3-months will be required for analysis and write-
up. 
Primary 
Endpoints: 
1. Collection of movement and erector spinae muscle activity data in all 
participants. 
2. A change over time in range of motion in any one plane of movement 
compared to pre-intervention range of motion. 
3. A change over time in Flexion-Relaxation response in those subjects 
where abnormal EMG activity in flexion during baseline assessment is 
detected. 
4. A change over time in maximum pain during movement score. 
(1-10 as recorded during the in-clinic ViMove assessment) for any one 
plane of movement.  
Secondary 
Endpoints: 
1. Capture changes in low back pain levels as assessed via a Numeric Rating 
Scale (NRS-Pain). 
2. Capture self-reported changes in functional status pre- and post- 
ThermaCare application as measured by the Oswestry Disability Index 
(ODI) and Roland Morris Disability Questionnaire (RMDQ) if subjects 
scored >3 on the NRS. 
3. Capture impression of change from subjects post ThermaCare application 
using the Patient Global Impression of Change Scale (PGIC). 
4. Observe changes in activity levels as collected by ViMove monitoring. 
5. Correlation of Low Back Pain Classifier (LBPC) Score to ViMove Scores for 
flexion and extension. 

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Inclusion Criteria: 
 
Inclusion criteria for recent low back pain patients: 
1. Adults between the age of 21-54 inclusive, male and female. 
2. Low back pain is the primary source of pain over the last 3 weeks. 
3. Have experienced and/or received treatment for muscle related low back 
pain with an average score of at least 3/10 on a 10-point Numeric Rating 
scale over the past 3 weeks. 
4. Must be able to communicate fluently in English. 
5. Must provide written informed consent. 
6. Must agree to confidentiality. 
Inclusion criteria for people who are active in sports: 
1. Adults between the age of 21-54 inclusive, male and female. 
2. Participate in 30 min of moderate to high intensity exercise 3 times per 
week, as defined by the Borg Rating of Perceived Exertion scale. 
3. Must be able to communicate fluently in English. 
4. Must provide written informed consent. 
5. Must agree to confidentiality. 
Exclusion Criteria: 1. The subject is pregnant. 
2. The subject has a severe hearing impairment or an inability to follow 
verbal instructions in English. 
3. The subject is cognitively impaired. 
4. Known allergic skin reaction to tapes and plasters. 
5. Co-morbidities of neoplasm, infection, fracture, inflammatory or 
metabolic disorder that has potential to affect the lumbo-pelvic region. 
6. Preceding chronic myelopathy, specific neurological disease or 
neurological changes. 
7. Person who is currently enrolled in another investigational drug or device 
study.  
8. Any past or current heart or blood-circulation related disorders. 
9.  The subject is contraindicated for this study for any other reason. 
Investigators: 
Principal Investigator 
Dr. Andrew Ronchi, 
dorsaVi Ltd 
Level 1, 120 Jolimont Rd,  
East Melbourne, Victoria, 3002 
Ph: (03) 9652 2192 
 
 
Co-Investigators 
Ms. Meagan Blackburn 
dorsaVi Ltd. 
Level 1, 120 Jolimont Rd,  
East Melbourne, Victoria, 3002 
Ph: (03) 9652 2198 
 
Mr. Jayce Gilbert 
Peak MSK Physiotherapy 
Suite 4/544 Hampton St,  
Hampton, Victoria, 3188 
Ph: (03) 9533 5305 
 
Dr. Sallie Cowan 
Clifton Hill Physiotherapy 
111 Queens Parade,  
Clifton Hill, Victoria, 3068 
Ph: (03) 9486 1918 
Mr. Michael Tricarico 
Hoppers Crossing Physiotherapy 
171 Heaths Rd, 
Hoppers Crossing, Victoria, 3029 
Ph: (03) 9749 5110 

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STUDY TITLE 
A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle 
relaxation & symptoms of low back pain in two different populations. 
STUDY INVESTIGATOR(S) 
Principal Investigator: Dr. Andrew Ronchi 
Co-Investigators: Ms. Meagan Blackburn, Dr. Sallie Cowan, Mr. Michael Tricarico, Mr. Jayce Gilbert. 
1: INTRODUCTION 
Low back pain commonly occurs in the general population, making it an important target for 
intervention. ThermaCare HeatWraps may prevent and relieve pain in regions such as the low back 
through continuous, low-level, direct heat therapy. 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. 
2: BACKGROUND 
Low Back Pain (LBP) is common in the general population with a 12-month point prevalence of 12% 
and 1-month prevalence of 23% [1]. Nonspecific LBP, the most common presentation, is defined as 
pain of unclear pathology below the costal margin and above the inferior gluteal folds [2-5]. Although 
the prognosis for LBP appears to be favorable, rates of chronicity are high [6] with previous LBP being 
a strong risk factor for ongoing complaint or relapse [7]. This makes LBP one of the leading causes of 
years lived with disability in developed countries [8], resulting in direct and indirect costs of $84.1 to 
$624.8 billion in the United States [9]. As such, addressing LBP effectively is necessary to minimize the 
associated physical and financial burden [10].  
There are numerous proposed methods to treat LBP. Effective interventions include spinal 
manipulation, and medications such as painkillers [11, 12]. However, these interventions can be 
invasive and are associated with extensive time requirements, high costs, and adverse side effects [13, 
14]. Thus, non-invasive and easy-to-administer treatments such as heat therapy may be preferred, 
although their effectiveness is not as consistent [12, 15]. One such heat therapy is in the use of 
ThermaCare HeatWraps (Pfizer Consumer Healthcare, Richmond, VA). ThermaCare is a brand of non-
invasive disposable heat wraps which provide the wearer with continuous low-level direct heat 
therapy for approximately 8 hours. ThermaCare HeatWraps are customized for specific parts of the 
body, including the low back. Clinical trials have demonstrated the efficacy of this intervention in the 
early treatment and prevention of Delayed Onset Muscle Soreness (DOMS) [5, 16]. Moreover, 
ThermaCare has been shown to be effective in the prevention of post-exercise pain and muscle 
soreness [16, 17]. Compared with the pain relievers ibuprofen and acetaminophen, ThermaCare 
provided more effective pain relief, and significantly improved flexibility and disability [18].  
However, these studies are limited in their assessment of pain and disability. Pain was often measured 
using Likert-scale questionnaires, as pain is an inherently subjective experience despite being 
physiologically determined [19]. Disability was assessed using more comprehensive questionnaires, 
but was not compared  with objective measures [20]. This is despite objective measures of movement 
being correlated with disability scores [21]. A Cochrane review assessing the efficacy of heat therapies 
such as ThermaCare, indicated that there is only moderate support from current research, as effects 

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are transient and relatively small [22]. However, these reviewed studies may be limited due to their 
qualitative and subjective measurement of pain and disability [23]. A systematic review and meta-
analysis further indicated that current heat therapy research is of “very-poor-quality” [24]. As such, 
validated, objective and quantitative data into muscle activity and movement is required, to provide 
insight into subjectively reported changes in pain and disability.  
Objective assessment of the association between pain and movement, and capturing a detailed view 
of the person’s movement, postures and activity levels is now possible due to the development of 
portable biofeedback sensors such as ViMove (dorsaVi Ltd). ViMove is wearable sensor technology, 
designed to precisely measure range of movement and static postures [25-27]. The device also 
measures low back muscle activity in real time through additional electromyography sensors. ViMove 
assessment of low back range of movement and posture has been shown to be highly correlated with 
3D kinematic measurement [26]. Normative low back range of movement values have also been 
determined and are available for the adult population (normative data has FDA clearance, available 
upon request). The device also demonstrates high intra- and inter-rater reliability as a low back 
measurement tool [27]. Objective information and feedback is provided to the practitioner as a report 
evaluating a patient’s movement and function/activity pre- and post- low back pain intervention. The 
wearable and portable nature of the device allows monitoring in non-clinical environments for up to 
24 hours (i.e. during normal daily activities). ViMove devices have TGA approval and FDA 510K 
clearance for use in Australia and the USA respectively. 
By utilizing ViMove, this study will objectively assess muscle activity and movement, prior to, during, 
and following the use of ThermaCare HeatWraps. This study will include 2 discrete population 
samples; (1) people with recent back pain, and (2) people who regularly play sport. As such, it will 
evaluate the efficacy of ThermaCare in these respective samples. Previous research has primarily 
assessed ThermaCare as an intervention in the USA, with the efficacy of ThermaCare not being 
examined in Australian samples. However, epidemiological studies indicate comparable prevalence of 
low back pain between the two countries [28, 29].  
 
 

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3: AIMS, HYPOTHESES, AND OBJECTIVES 
3.1 Aims 
The aims of this study are to evaluate the efficacy of ThermaCare HeatWraps: 
1. As an intervention for people with low back pain.  
2. As an intervention for people who are actively involved in sport. 
3.2 Hypotheses 
The Hypotheses for each aim are as follows: 
1. ThermaCare HeatWraps are an effective intervention for people with low back pain as it: 
a. Decreases pain during movement. 
b. Improves muscle relaxation. 
c. Increases flexibility (range of movement).  
2. ThermaCare HeatWraps are an effective intervention for people actively involved in sport as 
it: 
a. Improves muscle relaxation. 
b. Increases flexibility. 
c. Delays or reduces the incidence of pain as defined by an increase in existing pain or the 
occurrence of new pain. 
3.3 Objectives 
The objectives of this study are to determine if ThermaCare HeatWraps: 
1. Affect muscle relaxation, perceived pain, and flexibility in people with low back pain. 
2. Affect muscle relaxation, perceived pain, and flexibility in people who are actively involved in 
sport. 
3. Result in changes in subjective measures of pain and disability following 8-hours of usage. 
4. Induce changes in movement and surface muscle activity, by collecting and assessing objective 
movement and EMG data pre- and post- intervention. 
4: STUDY DESIGN 
This investigator-initiated study will utilize a prospective open-label study design. This allows the 
assessment of ThermaCare HeatWrap efficacy pre- and post- intervention, and may provide insight 
into the mechanisms of any observed pain relief. The nature of the ThermaCare intervention means 
that blinding is difficult, as there is no adequate placebo heat therapy.  
1. In clinic assessments: 
a. Obtainment of demographic data and brief medical history. 
b. ViMove Assessment comprised of:  
i. 
Assessment of Range of Movement (ROM) – Flexion, Extension, Lateral Flexion, and 
rotation, standing and sitting positions, walking (40m speed test), sit-to-stand test (number 
of repetitions in 30 seconds and movement pattern, lift and carry task and squatting task). 
ii. 
Simultaneous collection of muscle activity data using ViMove EMG sensors. 
c. Questionnaires: 
i. 
Oswestry Disability Index (ODI) 
ii. 
Roland Morris Disability Questionnaire 
iii. 
Low Back Pain Classifier 
iv. 
Numeric Scale for Pain (NRS-Pain) 
v. 
Patient’s Global Impression of Change Scale (PGIC) 

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2. Out of clinic assessments: 
a. ViMove Monitoring-  All day (out of clinic) monitoring assessment of: 
i. 
Peak angle ROM  
ii. 
Total ROM score  
iii. 
Total dynamic time over the monitoring period 
iv. 
Body orientation summary over monitoring session (% time spent sitting, standing, 
horizontal, dynamic) 
5: STUDY SETTING/LOCATIONS  
Both groups of participants will be recruited and assessed at the following clinics: 
1. Clifton Hill Physiotherapy. 111 Queens Parade, Clifton Hill, Victoria, 3068. 
2. Peak MSK Physiotherapy. Suite 4/544 Hampton St, Hampton, Victoria, 3188. 
3. Hoppers Crossing Physiotherapy. 171 Heaths Rd, Hoppers Crossing, Victoria, 3029. 
6: STUDY POPULATION 
20 participants will be recruited from each arm of the study, resulting in a total of 40 valid subjects.  
Although we will initially recruit 50 subjects, we expect an attrition rate of 20%. 
7: ELIGIBILITY CRITERIA 
7.1 Inclusion Criteria 
There are two respective sets of inclusion criteria which subjects from each study arm must meet to 
be eligible for the study: 
7.1.1 Inclusion Criteria for Low Back Pain Patients: 
1. Males and Females between the age of 21-54 inclusive. 
2. Low back pain is the primary source of pain over the last 3 weeks. 
3. Have experienced and received treatment for muscle related low back pain over the past 3 
weeks with an average score of at least 3/10 on a 10-point Numeric Rating Scale. 
4. Must be able to communicate fluently in English. 
5. Must provide written informed consent.  
6. Must agree to confidentiality. 
7.1.2 Inclusion Criteria for Active in Sport: 
1. Adults between the age of 21-54 inclusive, male and female. 
2. Participate in 30 min of moderate to high intensity exercise 3 times per week. 
- Intensity is assessed using the Borg Rating of Perceived Exertion (RPE) 
3. Must be able to communicate fluently in English. 
4. Must provide written informed consent. 
5. Must agree to confidentiality. 
 
 

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7.2 Exclusion Criteria 
Potential subjects who meet any of the following criteria will not be eligible for participation in this 
study: 
1. The subject is pregnant. 
2. The subject has a severe hearing impairment or an inability to follow verbal instructions in 
English. 
3. The subject is cognitively impaired. 
4. Known allergic skin reaction to tapes and plasters. 
5. Co-morbidities of neoplasm, infection, fracture, inflammatory or metabolic disorder that has 
potential to affect the lumbo-pelvic region. 
6. Preceding chronic myelopathy, specific neurological disease or neurological changes. 
7. Person who is currently enrolled in another investigational drug or device study.  
8. Any past or current heart or blood-circulation related disorders. 
9. The subject is contraindicated for this study for any other reason. 
7.3 Withdrawal Criteria 
The following are a list of reasons for participants to be discontinued from the trial by the Investigator: 
1. Withdrawal of Participant’s consent. 
2. Failure to maintain an adequate level of compliance with wearing sensors. 
3. Failure to co-operate adequately with the Principal Investigator or staff during clinical visits. 
4. Failure to adequately adhere to protocol requirements within or outside the clinical 
environment. 
5. Participant experiences a serious adverse event (see section 10) 
6. Participant no longer meets the inclusion criteria (see section 7.1) 
7. Pregnancy. 
8: STUDY PROCEDURES 
8.1 Recruitment of Subjects 
Two discrete groups of people will participate in this study.  
1. The first group will be comprised of patients who have experienced and/or received treatment 
for low back pain within the past 3 weeks. This group will be recruited from private 
physiotherapy clinics.  
2. The second group will be comprised of people who participate in 30-minutes of moderate-to-
high intensity exercise 3-times per week. This group will also be recruited from private 
physiotherapy clinics. 
8.2 Randomization 
This study has been designed as an initial feasibility study providing insights that would guide an RCT. 
As such, this is a non-randomized partially blinded study, as the investigator and participants will be 
blinded to ViMove results, but not the test condition. Groups will not be randomized, and will be based 
on recruitment. 

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8.3 Study Protocols  
8.3.1 Guidelines for Scheduling Subjects’ Clinic Visits 
Following enrolment into the study, an appointment is made for the subject within 3 weeks at their 
preferred clinic to begin the assessment.  
8.3.2 Study Personnel Training 
All personnel performing the ViMove fitting and assessment will undergo a training program in the 
use of the devices. 
8.4 Methodology  
The following tasks will be conducted on the recruitment day (Day 0) for all subjects, and will be 
recorded in each subject’s respective source documents and case report forms (CRFs): 
1. Assessment of eligibility against inclusion and exclusion criteria 
2. An explanation of study procedures. 
3. Provision and obtainment of written informed consent. 
4. Obtainment of demographic information and medical history. 
5. Booking of Day 1 and Day 2 (based on convenience). 
The main study will be conducted over 2 consecutive days for each subject. 
Participants will be asked to complete each of the following - 30 minutes prior to their appointment 
on Day 1; the Oswestry Disability Index (ODI), a Numeric Rating Scale for Pain (NRS Pain), the Roland 
Morris Disability Questionnaire, and a Low Back Pain Classifier.  
Both subject groups will then 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 ViMove 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. Participants 
will complete a Patient Global Impression of Change scale (PGIC), a repeat NRS, and will have another 
live ViMove assessment. 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”. ThermaCare 
will only be applied after the live assessment, so will not be worn at the same time as the EMG sensors. 
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, prior 
to the end-of-day live assessment. The subject will then be reimbursed for Day 2. A schedule of events 
can be seen in Table 1, and a summary of the procedure can be seen in Figure 1. 
 
 

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Table 1. Schedule of Events 
 
Visit 1* 
(Day 0) 
Enrol-
ment 
Visit 2* 
Baseline 
Start 
Interview 
(within 3 
weeks of 
Visit 1) 
Visit 3 
Baseline 
End of 
Day 
Interview 
Visit 4 
Intervention 
Start 
Interview 
Visit 5 
Intervention 
End of Day 
Interview 
Eligibility 
x 
 
 
 
 
Informed consent 
x 
 
 
 
 
Demographics & Medical History 
x 
 
 
 
 
Enrolment and scheduling 
x 
 
 
 
 
Questionnaires 
 
x 
 
  
x 
x 
ViMove application 
 
x 
 
x 
 
ViMove in clinic assessment 
 
x 
x 
x 
x 
ViMove monitoring assessment  
 
x 
 
x 
 
ViMove removal  
 
 
x 
 
x 
ThermaCare application 
 
 
 
x 
 
ThermaCare removal 
 
 
 
 
x 
Adverse Events 
 
x 
x 
x 
x 
Changes in medications 
 
x 
 
x 
 
Study Termination 
 
 
 
 
x 
*Baseline may occur on the same day as Visit 1 (i.e. enrolment). 
Subjects who withdraw from the study after providing informed consent are referred to as “drop-
outs” or premature withdrawals. The drop-out rate will be summarized. If the patient has provided a 
whole set of Day 1 data, this will be included in the study. 
We expect 6-months will be required from first participant enrolment to the last participant visit. A 
further 3-months will be required for analysis and write-up. 
 
 

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8.5 Measurement Tools Used 
8.5.1 ViMove Live – Range of Movement and Surface Muscle Activity 
ViMove is a validated and reliable tool used for measuring movement and muscle activity of the low 
back. The ViMove devices will be fitted during the “start interview”. This requires the attachment of 
the sensors to skin over the lumbar region with adhesive pads using the standardized protocol. 
ViMove will be used to provide the primary outcome measures relating to movement data, surface 
muscle activity and recording pain on movement. 
8.5.2 ViMove – Pain on movement 
Pain on movement compares subjective responses of pain, with objective movement data from 
ViMove sensors. Assessment requires subjects to move within a maximum tolerable range. A numeric 
pain rating scale (see below) will be used during each movement, to obtain a value for the level of 
pain that each subject experiences. Consistent and standardized instructions are used, with the pain 
scores being recorded in the ViMove system. If no pain on movement is reported, a score of 0 will be 
documented. 
(No Pain) 0         1         2         3         4         5         6         7           8         9         10 (Worst Pain) 
8.5.3 ViMove – Monitoring (Out-of-clinic Assessment) 
The monitoring period, in which subjects wear the ViMove devices during normal daily activity, aims 
to obtain or assess: 
1. Total time spent in a dynamic vs. static state. 
2. Sitting data; number and duration of sitting and walking events. 
3. Timed walking test. 
4. Postures and movement data throughout the day. 
8.5.4 Questionnaires  
The following questionnaires will be completed by subjects on a tablet onsite at their respective 
timepoints. 
Oswestry Disability Index (ODI) 
The ODI is a validated self-report questionnaire which quantifies the extent to which a person’s 
functional status is restricted by low back pain, and assesses the associated detriment [23]. It 
measures disability in the context of pain, rather than considering pain as the impairment. Ten 6-point 
scales assess the intensity (1) and effect (2) of pain on: personal care, lifting, walking, standing, sleep 
quality, sexual function, social life, and the ability to travel.  
Numeric Rating Scale for Pain (NRSP)  
The NRSP is a measure of pain intensity. It consists of a horizontal line anchored by 11 descriptions of 
pain (no pain vs. worst possible pain). Subjects are asked to circle a value along the line. The scale can 
be seen below: 
 
(No Pain) 0         1         2         3         4         5         6         7           8         9         10 (Worst Pain) 
 
 

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Roland Morris Disability Questionnaire 
The Roland-Morris Questionnaire (RMDQ) is a self-administered disability measure in which greater 
levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to 
yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to 
change over time for groups of patients with LBP. 
Patient’s Global Impression of Change Scale (PGIC) 
The PGIC assesses a subjects perceived efficacy of a treatment [30]. In the context of this study, it will 
assess the subject’s beliefs around any changes in their low back pain following the use of ViMove 
only (Baseline [Day 1]), and following the wearing of ViMove + ThermaCare (Intervention [Day 2]) 
during the respective periods of daily activity/monitoring. This assessment will utilize a 7-point scale 
as follows: 
 
Low Back Pain Classifier (LBPC) 
The Low Back Pain Classifier (LBPC) is a questionnaire which is available as part of the ViMove 
software. It can be completed electronically by patients or clinicians. The results are delivered as part 
of a Low Back Live Assessment Report. 
The LBPC was originally developed by Dr. Andrew Ronchi and extended/modified by Rob Laird. It was 
developed to assist clinicians gain a better understanding of the type of movement dysfunction 
affecting their patients. The questions direct clinicians towards lumbar flexion or extension biased 
aggravating activities. Questions 1-3 are about flexion aggravating activities and questions 4-6 relate 
to extension easing activities. Questions 7-9 are about extension aggravating activities whilst the final 
3 questions (10-12) are about flexion easing activities. There are now additional questions quantifying 
walking verses sitting aggravation. These questions serve two purposes: (i) measure walking and 
sitting with much greater precision than a RMDQ or ODI and (ii) to flag if an extension activity (walking) 
is better or worse than a flexion (maybe flexion but could be extension or loading problem in an 
upright sitting posture) activity. 
The questionnaire has not been formally validated. 
9: ANTICIPATED BENEFITS AND RISKS 
9.1 Potential Benefits 
We cannot guarantee that there will be any benefits from this research. However, possible benefits 
may include: 
1. Personal benefit: 
The ViMove in-clinic and monitoring (out-of-clinic) assessment data will be provided to the treating 
clinician after the baseline and follow-up sessions. Practitioners will receive a report detailing the 
participant’s movements during the assessment periods, and highlighting any abnormal movement 
patterns. The clinician may use this information to help educate the participant on healthier 
movement patterns and postures. 
(1) Very much improved  
(5) Minimally worse 
(2) Much improved 
(6) Much worse 
(3) Minimally improved 
(7) Very much worse 
(4) No change 

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ThermaCare HeatWraps may be beneficial due to it being a heat therapy, and the normally associated 
effects of such therapies. 
2. Assisting in the understanding of assessment data: 
This study will add to our knowledge of movement and activity in people with low back pain, and 
specifically how different factors related to back pain are influenced by each other. 
3. This study will further our understanding of the roles of both of self-reported functional 
questionnaires, ViMove data, and ThermaCare in the management and prevention of Low Back Pain. 
9.2 Potential Risks 
Possible risks, side effects, and discomforts include: 
Risk  
Likelihood 
Consequences 
ViMove not registering body 
movements 
 
Low 
Device will warn the health 
care professional (HCP) and 
subject that it can no longer 
provide assessment. If this 
occurs during a monitoring 
session you need to inform 
your HCP immediately. 
Possible irritation of the skin 
from wearing ViMove 
Low 
Low Skin Itching and/or 
discomfort for up to 8 hours. 
ThermaCare related issues 
Low 
Skin reactions to ThermaCare. 
This may include itching. 
Subjects may also be sensitive 
to heat. 
ViMove has undergone rigorous verification, validation, user acceptance and post market testing and 
is not expected to malfunction. However, anyone participating in this study who has concerns about 
the safety or other functioning of ViMove should report them immediately to the investigative team. 
9.2.1 Risk Minimization 
Ensuring the safety of participants is of upmost importance. As such, numerous protocols and 
procedures will be in place to minimize the risk of harm.  
• 
Strict adherence to the eligibility criteria is the foremost step in mitigating any potential harm.  
• 
Participants are also permitted to withdraw consent for any reason at any point in the trial.  
• 
Protocol for recording, reporting and follow-up of any adverse effects.  
• 
Selection of qualified investigators and site personnel. 
• 
Stringent training of investigative staff, regarding the use of questionnaires and devices. 
• 
This includes training of ViMove fitment and assessment. 
• 
ThermaCare usage has a risk of prolonged skin redness or burns for some people. Products 
will be applied and used as directed. 
 
 

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10: SAFETY CONSIDERATIONS 
An Adverse Event (AE) is any undesirable clinical occurrence in a Subject whether or not it is related 
to ThermaCare or ViMove. This includes a clinical sign, symptom, condition, and/or an observation of 
an unintended therapeutic effect. 
An Adverse Device Event is a clinical sign, symptom or condition that is caused by the presence of the 
device or the performance of the device system. 
A Serious Adverse Event (SAE) is an occurrence of: death, a life-threatening adverse event, inpatient 
hospitalization or prolongation of existing hospitalization, or a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions. 
10.1 Documentation and Reporting of Adverse Events 
All participants will be evaluated and monitored for AEs from recruitment. Once onset of an AE has 
been determined, evaluation will continue until its resolution is observed, or until the investigator 
determines that the subject’s condition is stable. The investigator will take appropriate and necessary 
therapeutic measures required for the resolution of the AD. Any medication necessary for the 
treatment of an adverse event must be recorded on the concomitant medication case report form. 
All AEs, regardless of severity, will be recorded in the source documents and CRFs using standard 
medical terminology. Colloquialisms and/or abbreviations should not be used. Only one medical 
concept, preferably a diagnosis rather than individual symptoms, should be recorded as the AE. 
If more than one distinct adverse event occurs, each event should be recorded separately. However, 
if a diagnosis (i.e., disease or syndrome) is known at the time of reporting, it should be recorded on 
the CRF rather than recording individual signs and symptoms (e.g. record congestive heart failure 
rather than dyspnea, rales and cyanosis). However, if a group of signs and/or symptoms cannot be 
medically characterized as a single diagnosis or syndrome at the time of reporting, each individual 
event should be recorded as a separate AE. A diagnosis that is subsequently established should be 
reported as follow-up information. However, signs and symptoms that are considered unrelated to an 
encountered syndrome or disease should be recorded as individual AEs (e.g. if congestive heart failure 
and severe headache are observed at the same time, each event should be recorded as an individual 
AE). 
Conditions or diseases that are chronic but stable should not be recorded on AE pages of the CRF but 
should be recorded on the medical history. Changes in a chronic condition or disease that are 
consistent with natural disease progression do not need to be recorded as adverse events and should 
not be recorded on the AE pages of the CRF.  
Adverse events occurring secondary to other events (e.g. sequelae) should be identified by the 
primary cause. A "primary" event, if clearly identifiable, should represent the most accurate clinical 
term to record as the AE event term. For example: Orthostatic hypotension, fainting and fall to floor, 
head trauma, neck pain. The primary event is orthostatic hypotension and the sequelae are head 
trauma and neck pain. 
 
 

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AE grading and severity are as follows: 
Grade 
1 
MILD 
Transient discomfort; no medical intervention/therapy 
required and does not interfere with daily activities. 
Grade 
2 
MODERATE 
Low level of discomfort or concern with mild to moderate 
limitation in daily activities; some assistance may be needed; 
minimal or no medical intervention/therapy required. 
Grade 
3 
SEVERE 
Extreme discomfort and limitation in daily activities; significant 
assistance required; significant medical intervention/therapy 
required. 
Note: There is a distinction between the severity and the 
seriousness of an adverse event. 
Severity is a measurement of intensity; thus, a severe reaction 
is not necessarily a serious adverse event (SAE). For example, 
a headache may be severe in intensity, but would not be 
serious unless it met one of the criteria for serious adverse 
events. 
Grade 
4 
POTENTIALLY 
LIFE-THREATENING OR 
DISABLING 
AE that is potentially life-threatening or may lead to a 
permanent disability.   
Grade 
5 
FATAL 
AE that leads to death. 
The relationship of an AE following the use of the devices (ThermaCare or ViMove) is classified as 
follows: 
UNRELATED 
Evidence indicates no plausible direct relationship to the devices such that: 
• 
A clinically plausible temporal sequence is inconsistent with the onset of 
the AE and device administration, and/or 
• 
A causal relationship is considered biologically implausible 
• 
The AE can be attributed to concurrent/underlying illness, other drugs or 
procedures. 
POSSIBLY 
RELATED 
Evidence indicates a possible relationship to the devices such that: 
1. The event occurs within a reasonable period of time relative to the 
treatment that makes a causal relationship possible, but plausible 
explanations may also be provided by other causes such as other drugs, 
products, chemicals, underlying disease, environment, etc. 
2. The event is possibly related to either of the devices. 

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RELATED 
Evidence indicates a reasonable temporal sequence of the event with device 
administration exists or that the association of the event with device 
administration is unknown and the event is not reasonably supported by other 
conditions such that: 
1. There is a clinically plausible time sequence between onset of the AE and 
device administration, and/or 
2. There is a biologically plausible mechanism for the device causing or 
contributing to the AE, and 
3. The AE cannot be reasonably attributed to concurrent/underlying illness, 
other drugs or procedures. 
The outcome of the AE is classified as one of the following: 
RESOLVED 
All symptoms associated with the AE have subsided. 
ONGOING 
Subject continues to experience some or all of the symptoms associated with 
the AE. 
FATAL 
Subject died as a result of the AE. 
10.2 Documentation and Reporting of Serious Adverse Events 
SAEs will be documented and reported in accordance with ICH Good Clinical Practice (GCP) guidelines 
[32]. SAE reporting procedures for investigator initiated studies are as follows: 
The Investigator must report all SAEs to the Human Research Ethics Committee Bellberry Ltd firstly by 
telephone and then via fax on an SAE form within 24 hours of learning of the event.  Any serious event 
that occurs at any time over the duration of the study, regardless of whether or not the subject has 
undergone any study-related procedures must be reported to Bellberry Ltd. 
Information on SAEs will be recorded on an SAE form. Blank copies are included in the study 
Investigator’s File.  
SAE forms should be directed to: 
Bellberry Ltd  
 
 
 
 
129 Glen Osmond Road, Eastwood 
 South Australia 5063 
 
 
Telephone:  
08 8361 3222  
 
 
Fax: 
 
08 8361 3322 
 
 
Email:   
bellberry@bellberry.com.au 
 
The Investigator should follow up the event until resolution or stabilization of the condition.  Follow-
up reports (as many as required) should be completed and emailed following the same procedure 
above. 
A final report is required in any case once the condition is resolved or stabilized and no more 
information about the event is expected. The final report should be completed and faxed following 
the same procedures above. 

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For deaths that occur following a Subject’s enrolment into the study a Record of Death CRF as well as 
an autopsy report (when/if available) must be submitted to Bellberry Ltd.  The Investigator must keep 
a copy of all documentation related to the event in the site’s study files. 
By participating in this study the Investigator agrees to submit reports of serious adverse events 
according to the timeline and method outlined in the protocol. In addition, the Investigator agrees to 
submit annual reports to his/her IRB/IEC as appropriate. The Investigator also agrees to provide 
Bellberry Ltd with a summary report within 30 days and full report within 60 days of completion of the 
Investigator’s participation in the study. 
10.3 Device-Related Observations (DROs) 
A device-related observation (DRO) is defined as any malfunction, failure to operate as defined by the 
Instructions for Use, technical problems, or operator error associated with use of the device. For each 
DRO, Investigators are to report the following to Bellberry Ltd.: 
• 
Date and time of DRO; 
• 
Description of DRO; 
• 
Serial number of the device with a complication; 
• 
Clinical consequences, if any (to be reported on an AE form); 
• 
Whether the device was replaced, and the serial number of the replacement; 
• 
Whether or not the procedure could be completed. 
11: STATISICAL CONSIDERATIONS AND DATA ANALYSIS 
11.1 Sample Size and Statistical Power 
The purpose of this study is feasibility testing to provide insights to develop a RCT. As such, a sample 
size of N=40, with 20 participants in each of the 2 population samples has been chosen. As we expect 
an attrition rate of 20%, we will initially recruit 50 subjects. 
11.2 Statistical Methods 
An initial descriptive analysis will be completed on the baseline measures of movement to determine 
mean scores, ranges and standard deviations of each sample group. This analysis will be repeated at 
later time points. Wilcoxon Signed Ranked Tests will be completed to determine if participant 
movement significantly changes following an intervention: One each for Baseline and Intervention. A 
repeated measures ANOVA will then be completed on all post trial data for the 2 separate groups to 
determine movement changes in the post-trial period.  
Bivariate correlational analyses through the Pearson product-moment coefficient, will be undertaken 
to determine if there is a relationship between movement and “pain on movement” using data 
collected at each time point. This potential relationship will be mapped to assess any temporal 
influences. 
Similarly, correlational analyses will be conducted to determine if there is a relationship between daily 
activity and ODI scores, using data collected at each of the four total time points. This potential 
relationship will also be mapped over time to determine if there are any temporal effects following 
initial treatment. 
All findings with a p-value < 0.05 will be deemed significant.  

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12: ETHICS CONSIDERATIONS 
The Investigator agrees that the study will be conducted in full accordance with the protocol, the 
principles of the ICH Guideline on GCP [32], the current revised principles of the Declaration of Helsinki 
[33], the National Statement on Ethical Conduct in Human Research [34], and applicable local laws 
and regulations of the country in which the research is conducted which provide the greatest 
protection to the individual.  
It is the Investigator’s responsibility to obtain written informed consent in compliance with ICH GCP 
Guidelines (Guidelines for Good Clinical Research Practice) from each subject prior to the Subject’s 
entrance into the study or the performance of any unusual, invasive, or non-routine procedure that 
involves risk to the Subject. The Investigator must also explain to the Subject that participation is 
voluntary and that they can withdraw from the study at any time without a reason and without having 
to fear any loss in his/her medical care. 
Prior to any study-related screening procedures being performed, the consent form will be reviewed 
and signed and dated by the Subject or legally authorized representatives and the person who 
administered the informed consent. 
Subjects will have sufficient time and opportunity to clarify and resolve questions before the Subject 
starts the study.  Furthermore, the Subject will be handed a Subject Information Sheet containing all 
the important information in writing.  A copy of the consent form will be given to the Subject or legally 
authorized representatives and the original will be placed in the Investigator Study File.  An entry must 
also be made in the Subject’s source documents to confirm that informed consent was obtained prior 
to any study-related procedures and that the Subject received a signed copy. 
The Investigator will submit the consent to the appropriate IRB/IEC for review and approval prior to 
the start of the study in this case Bellberry Ltd needs to approve the informed consent. If the consent 
form is revised during the course of the study, all active participating subjects must sign the revised 
form. 
12.1 Quality Assurance 
According to the ICH guidelines on GCP, the Investigator is responsible for implementing and 
maintaining quality assurance (QA) and quality control systems with written Standard Operating 
Procedures (SOPs). This is to ensure that the trial is conducted and data is generated, recorded and 
reported in compliance with the protocol, GCP and the applicable regulatory requirements. 
Data recorded on the Subject CRFs will be subjected to a quality control review according to the 
investigating site’s SOPs. All source document reviews will be performed against entries on the CRF 
and quality assurance checks will be performed to ensure that the Investigator is complying with the 
protocol and regulations.  
All data entered in the database will be verified and cleaned by the Data Management Team. Any 
discrepancies will be reviewed against the CRF hard copy and corrected. After completion of the entry 
process, computer logic checks will be run to check for such items as inconsistent study dates and 
outlying laboratory values. Any necessary corrections will be made to the database and documented 
via addenda or audit trails. 
On one or more occasions the study site may be audited by a third party or regulatory agency on 
behalf of the investigating site. 

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The Regulatory Authority or its designee, has the obligation to follow the study closely. The 
investigator may delegate or appoint a third party to monitor the study to ensure compliance with 
Good Clinical Practice (GCP). In doing so, the monitor will visit the Investigator and study facilities at 
periodic intervals, in addition to maintaining necessary telephone and written contact, as appropriate. 
The monitor will maintain a working knowledge of the study through observation, review of study 
records and source documentation, and discussion of the conduct of the study with the Investigator 
and staff. 
All aspects of the study will be carefully monitored by its designee for adherence to the protocol and 
for compliance with applicable government regulations, current good clinical practice, and current 
standard operating procedures. 
12.2 Confidentiality of Study Data 
The aims, contents, and results of this study are confidential and are not to be transmitted to any third 
party in any form or fashion without prior approval by the Principal Investigator and the study subject. 
The Investigator should keep a separate log (Subject Master List) of the assigned Subject numbers and 
corresponding names, addresses, telephone number and site number (if applicable). 
Permission for direct access to a Subject’s data will be sought in writing by the Investigator and from 
the Subject as part of the informed consent procedure. This gives permission to examine, analyze, 
verify, and reproduce any records and reports that are important to the evaluation of the study. Any 
party (e.g. domestic and foreign regulatory authorities, monitors and auditors) with direct access must 
take all reasonable precautions within the constraints of the applicable regulatory requirements to 
maintain the confidentiality of the subjects’ identities and the Hospital Authority’s proprietary 
information. 
It is the study monitor’s responsibility to verify that each Subject has consented, in writing, to direct 
access to their information. 
12.2.1 Case Report Forms 
CRFs are the sole property of the Investigator and should not be made available in any form to any 
third parties, expect for approved representatives of appropriate health, regulatory, or auditing 
authorities. 
As part of the responsibilities assumed by participating in the study, the Investigator agrees to 
maintain adequate case histories for the subjects treated under this protocol. The Investigator agrees 
to maintain accurate CRFs and source documentation as part of the case histories. 
All CRFs should be completed legibly in black ink or typed. Case report forms should never be 
completed in pencil. 
All requested information should be entered in the CRFs. If an item is not available or is not applicable, 
this fact should be so indicated. Blank spaces should not be present unless otherwise directed. A 
correction should be made by striking through the incorrect entry with a single line and by entering 
the correct information adjacent to it. The correction must be initialed and dated by the person 
making the correction. 
The Investigator must review, sign, and date each completed CRF in a timely manner. 
The Investigator will allow regulatory bodies to have direct access to the source documents to verify 
the data reported in the CRF. 

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12.2.2 Source Documents 
Source documents are the originals of any documents used by the Investigator or institution that allow 
verification of the existence of the Subject and substantiate the integrity of the data collected during 
the trial. Source documents may include hospital records, clinical and office charts, laboratory 
data/information, evaluation checklists, pharmacy dispensing and other records, recorded data from 
automated instruments, microfiches, photographic negatives, microfilm or magnetic media and/or x-
rays.  Source documents should be available to support all the data recorded in the CRF. 
13: STUDY OUTCOMES AND SIGNIFICANCE 
13.1 Primary Endpoints 
1. Collection of movement and erector spinae muscle activity data in all participants. 
2. Change over time in range of motion (ROM) in any one plane of movement compared to pre-
intervention ROM. 
3. A change over time in Flexion-Relaxation response in those subjects where abnormal EMG 
activity in flexion during baseline assessment is detected. 
4. A change over time in maximum pain during movement score (1-10 as recorded during the in-
clinic ViMove assessment) for any one plane of movement.  
13.2 Secondary Endpoints 
1. Capture changes in low back pain levels as assessed via a Numeric Rating Scale (NRS-Pain). 
2. Capture self-reported changes in functional status pre- and post- ThermaCare application as 
measured by the Oswestry Disability Index (ODI) and Roland Morris Disability Questionnaire 
(RMDQ) if subjects scored >3 on the NRS. 
3. Capture impression of change from subjects post ThermaCare application using the Patient 
Global Impression of Change Scale (PGIC). 
4. Observe changes in activity levels as collected by ViMove monitoring. 
5. Correlation of Low Back Pain Classifier (LBPC) Score to ViMove Scores for flexion and 
extension. 
 
13.3 Significance 
This intervention study will provide information regarding changes in movement, flexibility, and pain 
following the use of ThermaCare HeatWraps in subjects who either suffer from low back pain, or are 
moderately or highly active. Moreover, it will assess any potential relationships between changes in 
pain, and responses to questionnaires as well as objectively measurable changes using ViMove 
systems. 
 
 

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