Trial Outcomes & Findings for Low Intensity Ultrasound Therapy for Upper Back Pain Relief (NCT NCT02135094)
NCT ID: NCT02135094
Last Updated: 2020-04-02
Results Overview
Patients applied the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by numeric rating scale (NRS). NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. Device maybe be worn safely for 4 h per day for 7 days a week. Participants recorded NRS score daily (pre-treatment) and on days when the device was applied participants recorded pain 30 minutes into treatment, 2 hours into treatment and post-treatment (after 4 hours). The post-treatment score is used to find the week average and standard deviation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
Week 1, Week 2, Week 3, Week 4
Results posted on
2020-04-02
Participant Flow
Participant milestones
| Measure |
Active Ultrasound Therapy Device
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
8
|
|
Overall Study
Week 2
|
25
|
8
|
|
Overall Study
Week 3
|
25
|
8
|
|
Overall Study
Week 4
|
25
|
8
|
|
Overall Study
COMPLETED
|
25
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Intensity Ultrasound Therapy for Upper Back Pain Relief
Baseline characteristics by cohort
| Measure |
Active Ultrasound Therapy Device
n=25 Participants
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
n=8 Participants
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
Total
n=33 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
34.2 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
33.3 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
8 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Height
|
169.8 cm
STANDARD_DEVIATION 12.1 • n=5 Participants
|
169.1 cm
STANDARD_DEVIATION 9.7 • n=7 Participants
|
169.6 cm
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Weight
|
75.1 kg
STANDARD_DEVIATION 13.1 • n=5 Participants
|
72.2 kg
STANDARD_DEVIATION 22.4 • n=7 Participants
|
74.4 kg
STANDARD_DEVIATION 15.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4Patients applied the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by numeric rating scale (NRS). NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. Device maybe be worn safely for 4 h per day for 7 days a week. Participants recorded NRS score daily (pre-treatment) and on days when the device was applied participants recorded pain 30 minutes into treatment, 2 hours into treatment and post-treatment (after 4 hours). The post-treatment score is used to find the week average and standard deviation.
Outcome measures
| Measure |
Active Ultrasound Therapy Device
n=25 Participants
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
n=8 Participants
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
|---|---|---|
|
Pain on the Numeric Rating Scale (NRS)
Week 1
|
5.60 units on a scale
Standard Deviation 1.58
|
5.44 units on a scale
Standard Deviation 1.95
|
|
Pain on the Numeric Rating Scale (NRS)
Week 2
|
3.54 units on a scale
Standard Deviation 1.64
|
4.58 units on a scale
Standard Deviation 2.20
|
|
Pain on the Numeric Rating Scale (NRS)
Week 3
|
3.09 units on a scale
Standard Deviation 1.54
|
3.92 units on a scale
Standard Deviation 2.10
|
|
Pain on the Numeric Rating Scale (NRS)
Week 4
|
2.98 units on a scale
Standard Deviation 1.62
|
3.86 units on a scale
Standard Deviation 2.30
|
PRIMARY outcome
Timeframe: Day 1 through Week 1, Week 2, Week 3, and Week 4The Day 1 pre-treatment score was used to find the change in pain each week, rated on the numeric rating scale (NRS). NRS was rated from 0-10 with 0 being in no pain and 10 the worst pain possible. Weekly averaged post-treatment scores were subtracted from Day 1 pre-treatment score.
Outcome measures
| Measure |
Active Ultrasound Therapy Device
n=25 Participants
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
n=8 Participants
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
|---|---|---|
|
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Week 1 Change from Day 1
|
-2.05 units on a scale
Interval -2.76 to -1.35
|
-0.860 units on a scale
Interval -2.53 to 0.81
|
|
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Week 2 Change from Day 1
|
-2.34 units on a scale
Interval -3.03 to -1.65
|
-0.693 units on a scale
Interval -2.49 to 1.11
|
|
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Week 3 Change from Day 1
|
-2.51 units on a scale
Interval -3.18 to -1.83
|
-1.52 units on a scale
Interval -3.14 to 0.11
|
|
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Week 4 Change from Day 1
|
-2.61 units on a scale
Interval -3.34 to -1.9
|
-1.58 units on a scale
Interval -3.4 to 0.24
|
SECONDARY outcome
Timeframe: Day 1 through Week 4Participants recorded pain rated on the numeric rating scale (NRS) at 4 time points: before treatment, 30 minutes into treatment, 2 hours into treatment, and directly after treatment. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. The average time point scores across the study is used to assess pain during treatment.
Outcome measures
| Measure |
Active Ultrasound Therapy Device
n=25 Participants
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
n=8 Participants
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
|---|---|---|
|
Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
Before Treatment
|
5.40 units on a scale
Standard Deviation 1.50
|
5.22 units on a scale
Standard Deviation 2.14
|
|
Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
30 minutes into Treatment
|
4.99 units on a scale
Standard Deviation 1.39
|
4.98 units on a scale
Standard Deviation 2.13
|
|
Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
2 hours into Treatment
|
4.04 units on a scale
Standard Deviation 1.45
|
4.61 units on a scale
Standard Deviation 2.08
|
|
Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
Post-treatment
|
3.24 units on a scale
Standard Deviation 1.61
|
4.34 units on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Day 1 through Week 4The numeric rating scale (NRS) was used to assess pain before treatment, 30 minutes into treatment, 2 hours into treatment, and post-treatment. NRS range was from 0-10 with 0 being in no pain and 10 the worst pain possible. Change in pain was calculated by subtracting intra-treatment and post-treatment average scores from pre-treatment average score.
Outcome measures
| Measure |
Active Ultrasound Therapy Device
n=25 Participants
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
n=8 Participants
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
|---|---|---|
|
Change in Pain Rated on Numeric Rating Scale (NRS) From Pre-treatment to 30 Minutes Into Treatment, 2 Hours Into Treatment, and Post-treatment (4 Hours Into Treatment)
Pain score change after 30 minutes
|
-0.416 units on a scale
Interval -0.599 to -0.218
|
-0.237 units on a scale
Interval -0.713 to 0.239
|
|
Change in Pain Rated on Numeric Rating Scale (NRS) From Pre-treatment to 30 Minutes Into Treatment, 2 Hours Into Treatment, and Post-treatment (4 Hours Into Treatment)
Pain score change after 2 hours
|
-1.36 units on a scale
Interval -1.55 to -1.16
|
-0.615 units on a scale
Interval -1.09 to -0.145
|
|
Change in Pain Rated on Numeric Rating Scale (NRS) From Pre-treatment to 30 Minutes Into Treatment, 2 Hours Into Treatment, and Post-treatment (4 Hours Into Treatment)
Pain score change after 4 hours
|
-2.16 units on a scale
Interval -2.36 to -1.95
|
-0.885 units on a scale
Interval -1.37 to -0.394
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3, Week 4, OverallParticipants were asked to report how their body feels overall compared to the day before, on days when the ultrasound device (or placebo) were applied. The score was reported after the 4-hour treatment completion and rated on a 15-point global rating of change scale, with -7 being "a very great deal worse" than the day before, 0 being "no change" from the day before, and +7 being "a very great deal better" than the day before. The weekly average GROC and average GROC for the entire study (Overall) were assessed.
Outcome measures
| Measure |
Active Ultrasound Therapy Device
n=25 Participants
Patients receive treatment from the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The active device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity
Active ultrasound therapy device: low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
|
Placebo Ultrasound Therapy Device
n=8 Participants
Patients apply the Sam Ultrasonic Diathermy Device for 4 hours on days when their trapezius muscle pain score is at least a 3 on a scale of 0-10 (NRS). The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
Placebo ultrasound therapy device: The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
|
|---|---|---|
|
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Week 1
|
2.35 units on a scale
Standard Deviation 1.96
|
0.76 units on a scale
Standard Deviation 1.89
|
|
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Week 2
|
2.84 units on a scale
Standard Deviation 2.01
|
0.53 units on a scale
Standard Deviation 2.44
|
|
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Week 3
|
3.21 units on a scale
Standard Deviation 2.45
|
0.36 units on a scale
Standard Deviation 1.99
|
|
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Week 4
|
3.09 units on a scale
Standard Deviation 2.37
|
0.14 units on a scale
Standard Deviation 1.93
|
|
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Overall
|
2.84 units on a scale
Standard Deviation 2.21
|
0.46 units on a scale
Standard Deviation 2.08
|
Adverse Events
Active Ultrasound Therapy Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Ultrasound Therapy Device
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