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Low Intensity Ultrasound Therapy for Upper Back Pain Relief

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ClinicalTrials.gov Identifier: NCT02135094
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : June 11, 2018
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
ZetrOZ, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muscle Spasm
Interventions Device: Active ultrasound therapy device
Device: Placebo ultrasound therapy device
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 25 8
Week 2 25 8
Week 3 25 8
Week 4 25 8
Completed 25 8
Not Completed 0 0
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 25 8 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 8 participants 33 participants
34.2  (13.9) 30.3  (10.9) 33.3  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 8 participants 33 participants
Female
16
  64.0%
5
  62.5%
21
  63.6%
Male
9
  36.0%
3
  37.5%
12
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 8 participants 33 participants
25 8 33
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 25 participants 8 participants 33 participants
169.8  (12.1) 169.1  (9.7) 169.6  (11.4)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 25 participants 8 participants 33 participants
75.1  (13.1) 72.2  (22.4) 74.4  (15.0)
1.Primary Outcome
Title Pain on the Numeric Rating Scale (NRS)
Hide Description 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.
Time Frame Week 1, Week 2, Week 3, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 5.60  (1.58) 5.44  (1.95)
Week 2 3.54  (1.64) 4.58  (2.20)
Week 3 3.09  (1.54) 3.92  (2.10)
Week 4 2.98  (1.62) 3.86  (2.30)
2.Primary Outcome
Title Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Hide Description The 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.
Time Frame Day 1 through Week 1, Week 2, Week 3, and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 8
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Week 1 Change from Day 1
-2.05
(-2.76 to -1.35)
-0.860
(-2.53 to 0.810)
Week 2 Change from Day 1
-2.34
(-3.03 to -1.65)
-0.693
(-2.49 to 1.11)
Week 3 Change from Day 1
-2.51
(-3.18 to -1.83)
-1.52
(-3.14 to 0.110)
Week 4 Change from Day 1
-2.61
(-3.34 to -1.90)
-1.58
(-3.40 to 0.24)
3.Secondary Outcome
Title Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
Hide Description Participants 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.
Time Frame Day 1 through Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Before Treatment 5.40  (1.50) 5.22  (2.14)
30 minutes into Treatment 4.99  (1.39) 4.98  (2.13)
2 hours into Treatment 4.04  (1.45) 4.61  (2.08)
Post-treatment 3.24  (1.61) 4.34  (2.26)
4.Secondary Outcome
Title 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)
Hide Description The 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.
Time Frame Day 1 through Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 8
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Pain score change after 30 minutes
-0.416
(-0.599 to -0.218)
-0.237
(-0.713 to 0.239)
Pain score change after 2 hours
-1.36
(-1.55 to -1.16)
-0.615
(-1.09 to -0.145)
Pain score change after 4 hours
-2.16
(-2.36 to -1.95)
-0.885
(-1.37 to -0.394)
5.Secondary Outcome
Title Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Hide Description Participants 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.
Time Frame Week 1, Week 2, Week 3, Week 4, Overall
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 25 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 1 2.35  (1.96) 0.76  (1.89)
Week 2 2.84  (2.01) 0.53  (2.44)
Week 3 3.21  (2.45) 0.36  (1.99)
Week 4 3.09  (2.37) 0.14  (1.93)
Overall 2.84  (2.21) 0.46  (2.08)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Hide Arm/Group Description

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

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.

All-Cause Mortality
Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/8 (0.00%) 
Hide Serious Adverse Events
Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Ultrasound Therapy Device Placebo Ultrasound Therapy Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ralph Ortiz
Organization: Pain Management Associates
Phone: (607) 844-9979
EMail: rodoc@cnymail.com
Layout table for additonal information
Responsible Party: ZetrOZ, Inc.
ClinicalTrials.gov Identifier: NCT02135094    
Other Study ID Numbers: TP-02
201306603 ( Other Identifier: Schulman Associates IRB )
First Submitted: May 2, 2014
First Posted: May 9, 2014
Results First Submitted: May 9, 2018
Results First Posted: June 11, 2018
Last Update Posted: April 2, 2020