Trial Outcomes & Findings for A Prospective Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain (NCT NCT03151265)
NCT ID: NCT03151265
Last Updated: 2019-05-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Change from Baseline movement data after 1 consecutive day.
Results posted on
2019-05-10
Participant Flow
Participant milestones
| Measure |
Low Back Pain Group
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.
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.
|
Active in Sport Group
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 and muscle relaxation.
The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
n=20 Participants
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.
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Australia
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline movement data after 1 consecutive day.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
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
n=20 Participants
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.
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.
|
|---|---|---|
|
Change in Movement Data Over Time
|
2.74 Degrees
Standard Deviation 6.17
|
1.1 Degrees
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Change from Baseline Erector spinae muscle activity data after 1 consecutive day.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.
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
n=20 Participants
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.
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.
|
|---|---|---|
|
Change in Erector Spinae Muscle Activity Over Time
|
-.13 Ratio
Standard Deviation .28
|
-.019 Ratio
Standard Deviation .45
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Maximal range of low back movement in sagittal,axial and coronal planes. Results depict the change in Pelvis ROM in the sagittal plane.
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
n=20 Participants
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.
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.
|
|---|---|---|
|
A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion.
|
2.05 Degrees
Standard Deviation 6.6
|
3.11 Degrees
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Population: Pain scores were not captured for the sports group as 'no pain' is a selection criterion for this group.
Pain Score out of 10 as rated on the ViMove scale during movement assessment. Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in pain scores between baseline and post-intervention
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
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.
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.
|
|---|---|---|
|
In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement.
|
.3 score on a scale
Standard Error .58
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Surface EMG measurement of erector spinae muscle activity at L3 vertebra level
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
n=20 Participants
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.
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.
|
|---|---|---|
|
A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected.
|
-.13 Ratio
Standard Deviation .28
|
-.019 Ratio
Standard Deviation .45
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Population: Pain scores were not captured for the sports group as 'no pain' is a selection criterion for this group.
Pain Score out of 10 as measured on a Numeric Rating scale (NRS) Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in NRS scores between baseline and post-intervention
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
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.
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.
|
|---|---|---|
|
Change in Pain From Baseline
|
-.1 scale on a scale
Standard Error .71
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Population: ODI scores were not captured for the sports group as 'no pain/disability' is a selection criterion for this group.
Measurement of disability related to low back pain. Contains 10 sections, each of which can be from from 0-5 for a maximum score of 50. 50 indicates maximum possible disability (bed-bound - or are exaggerating their symptoms). The results depicted indicate the change in NRS scores between baseline and post-intervention
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
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.
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.
|
|---|---|---|
|
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 score on a scale
Standard Error 2.29
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Population: PGIC data were not collected for the Active in Sport Group, as subjects in this group were selected on the basis that they had no pain. As such, they would not have had an applicable impression of change related to pain.
Measurement of perceived change in Low back pain. Score from a scale of 1-7. 1 indicates no change (or condition has worsened), 7 indicates a considerable improvement. The results depicted indicate the change in PGIC scores between Day 1 and Day 2 (intervention)
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
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.
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.
|
|---|---|---|
|
Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC).
|
2.7 score on a scale
Standard Error .45
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline after 1 consecutive day.Population: RMDQ scores were not captured for the sports group as 'no pain/disability' is a selection criterion for this group.
Measurement of disability related to low back pain. A checklist of 24 items. A score of 24 indicates maximum disability.
Outcome measures
| Measure |
Low Back Pain Group
n=20 Participants
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.
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.
|
Active in Sport Group
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.
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.
|
|---|---|---|
|
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 score on a scale
Standard Error 2.00
|
—
|
Adverse Events
Low Back Pain Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active in Sport Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place