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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03151265




Registration number
NCT03151265
Ethics application status
Date submitted
9/05/2017
Date registered
12/05/2017
Date last updated
10/05/2019

Titles & IDs
Public title
A Prospective Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain
Scientific title
A Prospective Open Label Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain in Two Different Populations
Secondary ID [1] 0 0
2017THERMA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ThermaCare Low Back Heat Wrap

Experimental: 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.

Experimental: 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.


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Change from Baseline movement data after 1 consecutive day.
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Change from Baseline Erector spinae muscle activity data after 1 consecutive day.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Change from Baseline after 1 consecutive day.
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Change from Baseline after 1 consecutive day.
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Change from Baseline after 1 consecutive day.
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Change from Baseline after 1 consecutive day.
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Change from Baseline after 1 consecutive day.
Secondary outcome [6] 0 0
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)
Timepoint [6] 0 0
Change from Baseline after 1 consecutive day.
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Change from Baseline after 1 consecutive day.

Eligibility
Key inclusion criteria
Inclusion criteria for recent low back pain patients (Group 1):

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 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 (Group 2):

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 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.
Minimum age
21 Years
Maximum age
54 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria (applies to both Groups):

1. The subject is pregnant.

2. The subject has a severe hearing impairment.

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. Person who is currently enrolled in another investigational drug or device study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Clifton Hill Physiotherapy - Clifton Hill
Recruitment hospital [2] 0 0
Peak MSK Physiotherapy - Hampton
Recruitment hospital [3] 0 0
Hoppers Physio - Hoppers Crossing
Recruitment postcode(s) [1] 0 0
3068 - Clifton Hill
Recruitment postcode(s) [2] 0 0
3188 - Hampton
Recruitment postcode(s) [3] 0 0
3168 - Hoppers Crossing

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
dorsaVi Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03151265
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Ronchi, PhD
Address 0 0
dorsaVi Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications