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Trial registered on ANZCTR


Registration number
ACTRN12617000362392
Ethics application status
Approved
Date submitted
7/03/2017
Date registered
10/03/2017
Date last updated
16/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle relaxation & low back pain in two different populations.
Scientific title
A Prospective Open Label pilot study investigating the impact of ThermaCare on flexibility, muscle relaxation & low back pain in two populations: patients with recent low back pain, and people actively involved in sport.
Secondary ID [1] 291035 0
None
Universal Trial Number (UTN)
U1111-1192-2140
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain > 3 Weeks 301822 0
Condition category
Condition code
Musculoskeletal 301502 301502 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301503 301503 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ThermaCare Low-back HeatWraps provide continuous, low-level, direct heat therapy and will be evaluated in two population samples:
Group 1: participants with low back pain occuring for > 3 week,
Group 2: participants who engage in moderate-to-high intensity exercise 3 times a week or more as assessed by the Borg Perceived Exertion Scale

Efficacy of ThermaCare HeatWraps (Pfizer Consumer Healthcare) will be assessed using reliable and valid subjective measures of pain and disability, in conjunction with objective movement and function data (ViMove sensors, dorsaVi Ltd.)

The study will occur across two consecutive days. The first day will provide a baseline assessment of the participant, and will require the following from both groups:

Fitment of ViMove Sensors, followed by a ViMove in-clinic assessment of movement in the "start interview" of day 1
The participant will then leave the clinic whilst wearing the sensors, and will go about their day. This provides a baseline assessment of movement and activity.
The participant will return to the clinic after approximately 8-hours for an "end-of-day interview", and will be required to complete questionnaires assessing pain and disability. This will be followed by a 2nd ViMove in-clinic assessment. Sensors will then be removed for the day.

The second day will assess the efficacy of ThermaCare HeatWraps.
The procedure is almost identical to the first day, with the difference being the additional application of the HeatWrap during the "start interview".
The HeatWrap will be worn outside of the clinic for the 8-hour period, and will be removed following the completion of the "end-of-day interview".

These Heatwraps are wrapped around the low back of the participant and worn for 8 hours. They will be applied by the treating physician according to the manufacturer's instructions. Each heat wrap is designed to heat to about 40 degrees Celsius (104 F).

Intervention adherence will be assessed by the treating clinician during the end-of-day interview. No strategies will be utilised to improve adherence, other than the recommendations outlined by the clinician (i.e that the Wrap should be worn for the 8-hours unless you feel extremely uncomfortable etc.)
Intervention code [1] 297005 0
Treatment: Devices
Comparator / control treatment
Evaluation of the effect of ThermaCare HeatWraps on movement and pain when compared with no treatment.
Control group
Active

Outcomes
Primary outcome [1] 300917 0
Movement and erector spinae muscle activity data composite in all participants.
- maximum range of movement during lumbar flexion, extension, and lateral flexion
- Electromyography (EMG) data
Timepoint [1] 300917 0
This outcome will be assessed 4 times.

The timepoint for this outcome are the:
1. Start Interview of Day 1 (Baseline Assessment)
2. End of day interview of Day 1 (Baseline Assessment)
3. Start Interview of Day 2 (Intervention)
4. End of day interview of Day 2 (Intervention)

Baseline Assessment will be within 3 weeks of participant enrolment.
Baseline Assessment and Intervention will be consecutive days.
Primary outcome [2] 300918 0
A change over time in range of motion in any one plane of movement compared to pre-intervention range of motion as assessed by ViMove sensors.
Timepoint [2] 300918 0
The timepoint for this will be at the end of the intervention day (Day 2)
Primary outcome [3] 300919 0
Change over time in Flexion-Relaxation response in those subjects where abnormal EMG activity in flexion during baseline assessment is detected.

This outcome is assessed by using 2 surface electromyography sensors which are placed on the skin above the erector spinae muscles during the in-clinic assessment.
Timepoint [3] 300919 0
The timepoint for this will be at the end of the intervention day (Day 2)
Secondary outcome [1] 331177 0
A change in maximum pain during movement score following the intervention
(1-10 as recorded during the in-clinic ViMove assessment) for any one plane of movement.
Timepoint [1] 331177 0
The timepoint of this is the end of Day 2 (Intervention)
Secondary outcome [2] 331178 0
Observation of self-reported changes in functional status pre- and post- ThermaCare application as measured by the Oswestry Disability Index (ODI)
Timepoint [2] 331178 0
The timepoint for this is the end of Day 2 (Intervention)
Secondary outcome [3] 331179 0
The impression of change from participants post ThermaCare application, using the Patient Global Impression of Change Scale (PGIC)
Timepoint [3] 331179 0
The timepoint for this is the end of Day 2 (Intervention).

Eligibility
Key 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 received treatment for muscle related low back pain with an average score of at least 3/10 on a 10-point VAS 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 determined by the Borg 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
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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
Crossover
Other design features
Both participant samples (i.e. 1.Low back pain 2. Regularly engage in sport) will receive the same sequence of interventions, which will be as follows:

Day 1 (Baseline assessment day)
- No Intervention (i.e. ThermaCare)
- ViMove sensors still attached.

Day 2 (Intervention day)
-Intervention applied (i.e. ThermaCare HeatWrap)
- ViMove sensors attached.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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 Day 1 and Day 2. 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2017
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
20/12/2017
Date of last data collection
Anticipated
Actual
21/12/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15200 0
3131 - Forest Hill
Recruitment postcode(s) [2] 15201 0
3168 - Clayton
Recruitment postcode(s) [3] 15202 0
3068 - Clifton Hill

Funding & Sponsors
Funding source category [1] 295460 0
Commercial sector/Industry
Name [1] 295460 0
Pfizer Consumer Healthcare
Country [1] 295460 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
dorsaVi Ltd.
Address
Level 1, 120 Jolimont Road, East Melbourne, Victoria, 3002
Country
Australia
Secondary sponsor category [1] 294604 0
None
Name [1] 294604 0
Address [1] 294604 0
Country [1] 294604 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296794 0
Bellberry Ltd.
Ethics committee address [1] 296794 0
129 Glen Osmond Rd, Eastmond, South Australia, 5063
Ethics committee country [1] 296794 0
Australia
Date submitted for ethics approval [1] 296794 0
10/03/2017
Approval date [1] 296794 0
05/06/2017
Ethics approval number [1] 296794 0

Summary
Brief summary
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 patients 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
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72074 0
Dr Andrew Ronchi
Address 72074 0
dorsaVi Ltd.
Level 1, 120 Jolimont Road, East Melbourne, Victoria. 3002
Country 72074 0
Australia
Phone 72074 0
+61 3 9652 2192
Fax 72074 0
Email 72074 0
[email protected]
Contact person for public queries
Name 72075 0
Sangeeth Wanasinghage
Address 72075 0
dorsaVi Ltd.
Level 1, 120 Jolimont Road, East Melbourne, Victoria. 3002
Country 72075 0
Australia
Phone 72075 0
+61 422 106 668
Fax 72075 0
Email 72075 0
[email protected]
Contact person for scientific queries
Name 72076 0
Sangeeth Wanasinghage
Address 72076 0
dorsaVi Ltd.
Level 1, 120 Jolimont Road, East Melbourne, Victoria. 3002
Country 72076 0
Australia
Phone 72076 0
+61 422 106 668
Fax 72076 0
Email 72076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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