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

dorsaVi

Status: Completed

Conditions: Low Back Pain

Treatments: Device: ThermaCare Low Back Heat Wrap

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03151265

2017THERMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Low Back Pain Group

Experimental group

Description:

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.

Treatment:

Device: ThermaCare Low Back Heat Wrap

Active in Sport Group

Experimental group

Description:

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:

Device: ThermaCare Low Back Heat Wrap