Muscle SpasmNCT02135094
Low Intensity Ultrasound Therapy for Upper Back Pain Relief
A study testing Active ultrasound therapy device in people with Muscle Spasm, run by ZetrOZ, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Spasm
- What is being tested?
- Active ultrasound therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65 years.
- Has acute trapezius muscle pain that has been assessed by a health care practitioner.
- Has a NRS pain severity score of 3.0 or higher in the trapezius muscle 3-4 times over the past week prior to enrolling in the trial.
- Subjects must be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the device under test.
- Not taken any prescription pain medications or muscle relaxers in the 5 days prior to the study and agree not to take any during the study and to maintain any dosage of NSAIDs (nonsteroidal antiinflammatory drug) or non-prescription pain medications constant during the study
- Has access to a mobile phone or camera and the help of another individual to take a picture of the upper back area immediately after use of the device
Who cannot join
- Subjects with known neuropathy will be excluded from the study
- Women who are pregnant may not participate.
- Prisoners
- Smokers
- Subjects with Type I or Type II Diabetes
- Subjects who have had surgery in the target area within the last 6 months will be excluded from the study.
Show all 19Show fewer
- Subjects who are non-ambulatory (i.e. who cannot walk) will be excluded from the study.
- Subjects who refuse to agree to not increase current use or initiate new use of pain medication during the course of the trial unless medically necessary to ensure patient safety.
- Subjects who refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study.
- Subjects who refuse to discontinue massage therapy or spinal manipulation during the duration of this study.
- Subjects who have had massage therapy within 1 day of beginning the protocol
- Subjects who refuse to discontinue all other interventional treatment modalities (i.e. transcutaneous electrical nerve stimulation (TENS), ultrasound)
- Subjects who had a local corticosteroid or PRP (platelet-rich plasma) injection within the past 3 months.
- Subjects who have a clinically significant or unstable medical or psychological conditions that would compromise participation in the study.
- Subjects who have participated in another clinical trial for an investigational drug and/or agent within 30 days prior to screening.
- Subjects involved in any injury-related litigation in the target area.
- Subjects with abnormal neurological history, lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus (gel-like substance within a spinal disc), or other structural defects.
- Subjects with back pain related to major trauma in the last 6 months
- Subjects with open sores or wounds in the treatment area that would prevent use of the device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Term Effects of Long Duration Low Intensity Continuous Ultrasound for Trapezius Muscle Pain
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound device will lower the reported daily pain level of subjects suffering from trapezius muscle pain in their upper back.
Subjects who participate in the study will self-administer the ultrasound device daily if pain is rated 3.0 or higher on the numeric rating scale (0-10). Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary. Subject will also report pain levels at 30 min, 2 hours, and 4 hours (treatment completion) after start of each treatment.
The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and increased circulation.
Read the detailed description
The study will have approximately 33 subjects randomly assigned into a user group (active ultrasound device) of 25 participants or a control group (inactive ultrasound device) of 8 participants with an equal number of males and females in each group. The research coordinator will be blinded to the assignment of devices to each group.
The daily pain scores reported by patients who receive active devices will be compared to those who receive placebo devices.
Background:
Approximately 50 to 80 million people in the United States suffer from some form of chronic pain. Back pain is the most common neurological disorder in the United States after headaches and costs consumers nearly $50 billion annually. Pharmaceuticals currently dominate the treatment options despite a myriad of public health problems including cost, untoward side effects, and addiction to widely available opioid analgesics. Non-pharmaceutical treatments, such as the one under test, provide a safer and potentially lower cost alternative to traditional analgesic use.
- Conditions
- Muscle Spasm
- Being tested
- Active ultrasound therapy device, Placebo ultrasound therapy device
- Keywords
- trapezius, upper back, muscle pain, pain relief, ultrasound, double blind, Sam, ZetrOZ, muscle, LITUS, low intensity therapeutic ultrasound
- Medical subject headings
- Spasm, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ultrasound therapy deviceDevice
Also called ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS 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 deviceDevice
Also called ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS device
The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Active ultrasound therapy device | Experimental | 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 Receives: Device: Active ultrasound therapy device |
| Placebo ultrasound therapy device | Placebo comparator | 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. Receives: Device: Placebo ultrasound therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the Numeric Rating Scale (NRS)
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.
Measured: Week 1, Week 2, Week 3, Week 4
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
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.
Measured: Day 1 through Week 1, Week 2, Week 3, and Week 4
Secondary outcomes (3)
Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
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.
Measured: Day 1 through Week 4
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)
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.
Measured: Day 1 through Week 4
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
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.
Measured: Week 1, Week 2, Week 3, Week 4, Overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZetrOZ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George K. Lewis, PhD, Principal investigator, ZetrOZ, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135094
- Sponsor's protocol ID
- TP-02
- Other IDs
- 201306603
- Status last verified
- Mar 2020
- First submitted
- 2 May 2014
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Petterson S, Plancher K, Klyve D, Draper D, Ortiz R. Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial. J Pain Res. 2020 Jun 2;13:1277-1287. doi: 10.2147/JPR.S247463. eCollection 2020.
PubMed 32606899
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effects of Long Duration Low Intensity Continuous Ultrasound for Trapezius Muscle Pain
- ClinicalTrials.gov ID
- NCT02135094
- Acronym / sponsor ID
- TP-02
- Conditions
- Muscle Spasm
- Keywords
- trapezius, upper back, muscle pain, pain relief, ultrasound, double blind, Sam, ZetrOZ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- ZetrOZ, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 11 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device for relief of pain associated with the trapezius muscle of the upper back over a 4-week period. The trapezius muscle is a wide, flat, superficial muscle that covers most of the upper back and the posterior of the neck.The hypothesis is that the ultrasound device will lower the reported daily pain level of subjects suffering from trapezius muscle pain in their upper back.
Subjects who participate in the study will self-administer the ultrasound device daily if pain is rated 3.0 or higher on the numeric rating scale (0-10). Subjects will be required to visit the clinical site at enrollment and weeks 2 and 4 for a total of 3 visits. Subjects will report their daily pain levels in a diary. Subject will also report pain levels at 30 min, 2 hours, and 4 hours (treatment completion) after start of each treatment.
The wearable ultrasound device, Sam®, has been cleared by the FDA for pain relief, relief of joint contracture, relief of muscle spasm, and increased circulation.
Detailed description
The study will have approximately 33 subjects randomly assigned into a user group (active ultrasound device) of 25 participants or a control group (inactive ultrasound device) of 8 participants with an equal number of males and females in each group. The research coordinator will be blinded to the assignment of devices to each group.
The daily pain scores reported by patients who receive active devices will be compared to those who receive placebo devices.
Background:
Approximately 50 to 80 million people in the United States suffer from some form of chronic pain. Back pain is the most common neurological disorder in the United States after headaches and costs consumers nearly $50 billion annually. Pharmaceuticals currently dominate the treatment options despite a myriad of public health problems including cost, untoward side effects, and addiction to widely available opioid analgesics. Non-pharmaceutical treatments, such as the one under test, provide a safer and potentially lower cost alternative to traditional analgesic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active ultrasound therapy device | Experimental | Device: Active ultrasound therapy devicePatients 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 |
| Placebo ultrasound therapy device | Placebo comparator | Device: Placebo ultrasound therapy devicePatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 18 and 65 years.
- Has acute trapezius muscle pain that has been assessed by a health care practitioner.
- Has a NRS pain severity score of 3.0 or higher in the trapezius muscle 3-4 times over the past week prior to enrolling in the trial.
- Subjects must be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the device under test.
- Not taken any prescription pain medications or muscle relaxers in the 5 days prior to the study and agree not to take any during the study and to maintain any dosage of NSAIDs (nonsteroidal antiinflammatory drug) or non-prescription pain medications constant during the study
Key exclusion criteria (19 listed)
- Subjects with known neuropathy will be excluded from the study
- Women who are pregnant may not participate.
- Prisoners
- Smokers
- Subjects with Type I or Type II Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ultrasound therapy deviceAlso: ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS devicelow intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day | Device | Active ultrasound therapy device |
| Placebo ultrasound therapy deviceAlso: ZetrOZ ultrasound device, wearable ultrasound device, long duration ultrasound, LITUS deviceThe placebo device appears and operates identically to the active device except that it does not emit ultrasound. | Device | Placebo ultrasound therapy device |
Primary outcome
Pain on the Numeric Rating Scale (NRS)
Time frame: Week 1, Week 2, Week 3, Week 4
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.
Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.
Time frame: Day 1 through Week 1, Week 2, Week 3, and Week 4
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.
3 secondary outcomes
Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.
Time frame: Day 1 through Week 4
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)
Time frame: Day 1 through Week 4
Comparison of Pain Level Using Global Rating of Change (GROC) Scale.
Time frame: Week 1, Week 2, Week 3, Week 4, Overall
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32606899Petterson S, Plancher K, Klyve D, Draper D, Ortiz R. Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial. J Pain Res. 2020 Jun 2;13:1277-1287. doi: 10.2147/JPR.S247463. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George K. Lewis, PhD principal investigator
ZetrOZ, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active ultrasound therapy device in people with Muscle Spasm, run by ZetrOZ, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on the Numeric Rating Scale (NRS) (time frame: Week 1, Week 2, Week 3, Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.