Clinical trial NCT03151265: A Prospective Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain
Official title: A Prospective Open Label Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain in Two Different Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Functional Outcome Measures
Wearable Sensors
ViMove
Low Back Pain
Range of Movement
Muscle Activity
ThermaCare
Lead sponsor: dorsaVi Ltd
Sponsor class: INDUSTRY
Collaborators: name: Monash University
First posted: 2017-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

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.

Primary outcomes:
measure: Change in Movement Data Over Time
timeFrame: Change from Baseline movement data after 1 consecutive day.
measure: Change in Erector Spinae Muscle Activity Over Time
timeFrame: Change from Baseline Erector spinae muscle activity data after 1 consecutive day.
Secondary outcomes:
measure: A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion.
timeFrame: Change from Baseline after 1 consecutive day.
measure: In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement.
timeFrame: Change from Baseline after 1 consecutive day.
measure: A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected.
timeFrame: Change from Baseline after 1 consecutive day.
measure: Change in Pain From Baseline
timeFrame: Change from Baseline after 1 consecutive day.
measure: 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
timeFrame: Change from Baseline after 1 consecutive day.
measure: Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC).
timeFrame: Change from Baseline after 1 consecutive day.
measure: 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
timeFrame: Change from Baseline after 1 consecutive day.
Other outcomes:
Locations:
city: Clifton Hill
country: Australia
facility: Clifton Hill Physiotherapy
state: Victoria
city: Hampton
country: Australia
facility: Peak MSK Physiotherapy
state: Victoria
city: Hoppers Crossing
country: Australia
facility: Hoppers Physio
state: Victoria
Study officials:
affiliation: dorsaVi Ltd
name: Andrew Ronchi, PhD
role: PRINCIPAL_INVESTIGATOR
References: