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

NCT03151265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-05-10

Study results available
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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

Interventions

DEVICE

ThermaCare Low Back Heat Wrap

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.

Sponsors & Collaborators

Principal Investigators

  • Andrew Ronchi, PhD · dorsaVi Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
54 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2017-12-21
Completion
2017-12-21
FDA Device
Yes

Countries

  • Australia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03151265 on ClinicalTrials.gov