Low Back PainNCT03151265

A Prospective Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain

A study testing ThermaCare Low Back Heat Wrap in people with Low Back Pain, run by dorsaVi Ltd at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 54 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: ThermaCare Low Back Heat Wrap
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesAustralia
Study dates: 3 Jul 2017to 21 Dec 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 54 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

None listed.

Who cannot join

The subject is pregnant.
The subject has a severe hearing impairment.
The subject is cognitively impaired.
Known allergic skin reaction to tapes and plasters.
Co-morbidities of neoplasm, infection, fracture, inflammatory or metabolic disorder that has potential to affect the lumbo-pelvic region.
Person who is currently enrolled in another investigational drug or device study.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

Clifton Hill Physiotherapy
Clifton Hill, Victoria, 3068
Peak MSK Physiotherapy
Hampton, Victoria, 3188
Hoppers Physio
Hoppers Crossing, Victoria, 3168

Other trials in Australia

About this study

Official title: A Prospective Open Label Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain in Two Different Populations

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.

Read the detailed description

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.

Conditions: Low Back Pain
Being tested: ThermaCare Low Back Heat Wrap
Keywords: Functional Outcome Measures, Wearable Sensors, ViMove, Low Back Pain, Range of Movement, Muscle Activity, ThermaCare
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ThermaCare Low Back Heat WrapDevice
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.

Study groups in NCT03151265
Study group	Role	What they receive
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. Receives: Device: ThermaCare Low Back Heat Wrap
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. Receives: Device: ThermaCare Low Back Heat Wrap

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Change from Baseline Erector spinae muscle activity data after 1 consecutive day.

Secondary outcomes (7)

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.
Measured: 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.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: Change from Baseline after 1 consecutive day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jul 201721 Dec 2017

First posted12 May 2017
Study start3 Jul 2017
Primary completion21 Dec 2017
Study completion21 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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).
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03151265
Sponsor's protocol ID: 2017THERMA
Status last verified: Apr 2019
First submitted: 9 May 2017
Last updated: 10 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Open Label Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain in Two Different Populations
ClinicalTrials.gov ID: NCT03151265
Acronym / sponsor ID: 2017THERMA
Conditions: Low Back Pain
Keywords: Functional Outcome Measures, Wearable Sensors, ViMove, Low Back Pain, Range of Movement, Muscle Activity, ThermaCare
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: dorsaVi LtdIndustry (pharma, biotech, devices)
Collaborators: Monash University
Study start: 3 Jul 2017 (actual)
Primary completion: 21 Dec 2017 (actual)
Study completion: 21 Dec 2017 (actual)
First posted: 12 May 2017 (actual)
Results: Posted 10 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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).

Arm	Type	Receives
Low Back Pain Group	Experimental	Device: ThermaCare Low Back Heat WrapLow 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	Device: ThermaCare Low Back Heat WrapSport 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.

Who may qualify

Ages: 21 to 54 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (6 listed)

The subject is pregnant.
The subject has a severe hearing impairment.
The subject is cognitively impaired.
Known allergic skin reaction to tapes and plasters.
Co-morbidities of neoplasm, infection, fracture, inflammatory or metabolic disorder that has potential to affect the lumbo-pelvic region.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ThermaCare Low Back Heat WrapThe 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.	Device	Active in Sport Group, Low Back Pain Group

Primary outcome

Change in Movement Data Over Time
Time frame: Change from Baseline movement data after 1 consecutive day.
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 in Erector Spinae Muscle Activity Over Time
Time frame: Change from Baseline Erector spinae muscle activity data after 1 consecutive day.
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.

7 secondary outcomes

A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion.
Time frame: 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.
Time frame: Change from Baseline after 1 consecutive day.
A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected.
Time frame: Change from Baseline after 1 consecutive day.
Change in Pain From Baseline
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: Change from Baseline after 1 consecutive day.

Results and safety

Results posted to the registry on 10 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Back Pain Group	20	20
Active in Sport Group	20	20

Primary outcome: Change in Movement Data Over Time

Time frame: Change from Baseline movement data after 1 consecutive day.. Mean (Standard Deviation). Unit: Degrees

Measure	Low Back Pain Group n = 20	Active in Sport Group n = 20
Value	2.74 (6.17)	1.1 (6.9)

Primary outcome: Change in Erector Spinae Muscle Activity Over Time

Time frame: Change from Baseline Erector spinae muscle activity data after 1 consecutive day.. Mean (Standard Deviation). Unit: Ratio

Measure	Low Back Pain Group n = 20	Active in Sport Group n = 20
Value	-.13 (.28)	-.019 (.45)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Back Pain Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Active in Sport Group	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Ronchi, PhD principal investigator

dorsaVi Ltd

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ThermaCare Low Back Heat Wrap in people with Low Back Pain, run by dorsaVi Ltd at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Movement Data Over Time (time frame: Change from Baseline movement data after 1 consecutive day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03151265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.