N/A
Completed N=40
A Prospective Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain
Source: ClinicalTrials.gov NCT03151265 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change in Movement Data Over Time — 2.74; 1.1 Degrees
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Movement Data Over Time |
2.74; 1.1 | — |
| PRIMARY Change in Erector Spinae Muscle Activity Over Time |
-.13; -.019 | — |
| SECONDARY A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion. |
2.05; 3.11 | — |
| SECONDARY In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement. |
.3 | — |
| SECONDARY A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected. |
-.13; -.019 | — |
| SECONDARY Change in Pain From Baseline |
-.1 | — |
| SECONDARY 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 |
.70 | — |
| SECONDARY Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC). |
2.7 | — |
| SECONDARY 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 |
.20 | — |
Eligibility Criteria
Inclusion criteria for recent low back pain patients (Group 1):
- 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.
Inclusion criteria for people who are active in sports (Group 2):
- 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.
Exclusion Criteria (applies to both Groups):
- 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.
Data sourced from ClinicalTrials.gov (NCT03151265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.