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

NCT03151265 | Completed Results FDA Device

• 1 other identifier: 2017THERMA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Back Pain

Keywords

Functional Outcome Measures; Wearable Sensors; ViMove; Low Back Pain; Range of Movement; Muscle Activity; ThermaCare

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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.

  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.

  Change from Baseline after 1 consecutive day.

• A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected.

  Change from Baseline after 1 consecutive day.

• Change in Pain From Baseline

  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

  Change from Baseline after 1 consecutive day.

Study Arms (2)

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.

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.

Device: ThermaCare Low Back Heat Wrap

Interventions

ThermaCare Low Back Heat Wrap DEVICE

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.

Active in Sport Group; Low Back Pain Group

Eligibility Criteria

• Age: 21 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between the age of 21-54 inclusive, male and female.
• Low back pain is the primary source of pain over the last 3 weeks.
• 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.
• Must be able to communicate fluently in English.
• Must provide written informed consent.
• Must agree to confidentiality.
• Adults between the age of 21-54 inclusive, male and female.
• Participate in 30 min of moderate to high intensity exercise 3 times per week. As defined by Borg Rating of Perceived Exertion scale.
• Must be able to communicate fluently in English.
• Must provide written informed consent.
• Must agree to confidentiality.

You may not qualify if:

• 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.

Sponsors & Collaborators

• dorsaVi Ltd: lead
• Monash University: collaborator

Study Sites (3)

Clifton Hill Physiotherapy

Clifton Hill, Victoria, 3068, Australia

Location

Peak MSK Physiotherapy

Hampton, Victoria, 3188, Australia

Location

Hoppers Physio

Hoppers Crossing, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sangeeth Wanasinghage
• Organization: dorsaVi Ltd

support@dorsavi.com

+61 1800 367 728

Study Officials

• Andrew Ronchi, PhD

  dorsaVi Ltd

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study is open label, meaning that no masking occurs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: July 3, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-04

Locations

AU (3)