A Prospective Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Intervention name(s): ThermaCare Low Back Heat Wrap
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional Outcome Measures; Wearable Sensors; ViMove; Low Back Pain; Range of Movement; Muscle Activity; ThermaCare