Pain, BackNCT07256626
Tune Up Your Back: Soundwave Wellness Study
A study testing WAVWatch 2.0 in people with Pain, Back, run by Efforia, Inc at 1 site in United States.
Trial summary
Looking to support your back mobility and overall comfort? Join our study exploring WAVwatch 2.0, an innovative soundwave therapy device. This non-invasive technology is designed for individuals who want to maintain easy movement and flexibility without constantly reaching for over-the-counter options. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain, Back
- What is being tested?
- WAVWatch 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Looking to support your back mobility and overall comfort? Join our study exploring WAVwatch 2.0, an innovative soundwave therapy device. This non-invasive technology is designed for individuals who want to maintain easy movement and flexibility without constantly reaching for over-the-counter options. By joining, you'll discover how this gentle approach may help support everyday back comfort, mobility, and flexibility.
Read the detailed description
This remotely administered decentralized trial is designed to methodically explore the efficacy of WAVwatch 2.0, a non-invasive device that leverages soundwave therapy, in enhancing back comfort and flexibility. In the wake of increasing reliance on temporary solutions for back tension and stiffness, this study emerges as a pivotal investigation into whether soundwave therapy can offer a sustainable pathway to maintaining ease of back movement and overall wellness.
The primary objective of this online trial is to facilitate participants in understanding the potential benefits of WAVwatch 2.0 on their daily comfort, range of motion, and general quality of life. Through this exploratory journey, participants will receive personalized insights, enabling a comprehensive understanding of how soundwave therapy might influence their back comfort and mobility. This initiative aims not only to assess the device's ability to support back wellness but also to empower participants with knowledge about alternative, non-invasive options for enhancing their quality of life.
Focusing on the experiential changes in ease of movement, daily activities, and overall wellness, the study intends to rigorously evaluate and document the impact of WAVwatch 2.0 on participants. By doing so, it seeks to offer a detailed perspective on the device's effectiveness in promoting back health and comfort. The trial is committed to providing participants with a clear, personalized overview of how soundwave therapy could integrate into their wellness routines, potentially redefining approaches to back care.
The significance of this remotely conducted trial extends beyond individual benefits, aiming to contribute to the broader understanding of non-invasive back care solutions. By examining the outcomes of using WAVwatch 2.0 for back comfort and mobility, the study aspires to challenge and expand current perspectives on managing back tension and stiffness, offering new insights into the role of soundwave therapy in daily wellness practices.
It is important to note that throughout this trial, the PROMISE and ROMISE scales will serve as key tools in assessing participants' quality of life, comfort, and ease of movement. These scales, while integral to evaluating the benefits of WAVwatch 2.0, are not utilized as diagnostic instruments but as means to gauge the subjective experience of participants, thereby enriching the study's findings on the feasibility of soundwave therapy as a supportive measure for back wellness.
- Conditions
- Pain, Back
- Being tested
- WAVWatch 2.0
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVWatch 2.0Device
The WAVwatch sound frequency therapy device employs acoustic waves absorbed through the skin to promote wellness, with manufacturers and users reporting minimal safety risks
| Study group | Role | What they receive |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Single arm where participants act as their own control Receives: Device: WAVWatch 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS® Item Bank/Scale v.2.0 - Pain Behavior Survey
This survey aims to understand individual behaviors and reactions when experiencing pain within the past 7 days.
Measured: Change from baseline (Day 1-3) in pain behavior at 4 weeks after the start of the intervention (Day 27-33)
Quality of Life and Health Survey
This survey asks about your feelings towards your quality of life, health, and various areas of your life. It covers your experiences and feelings in the past four weeks. Please choose the answer that appears most appropriate.
Measured: Change from baseline (Day 1-3) in quality of life at 4 weeks after the start of the intervention (Day 27-33)
ROMIS® Numeric Rating Scale v.1.0 - Pain Intensity 1a
This survey is designed to understand the level of pain experienced by the participant in the past 7 days. The responses will help in assessing the pain intensity from no pain to worst imaginable pain.
Measured: Change from baseline (Day 1-3) in pain intensity at 1 week after the start of the intervention (Day 4-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start25 Aug 2025
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BackStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm observational where participants act as their own control
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efforia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256626
- Sponsor's protocol ID
- 37378
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tune Up Your Back: Soundwave Wellness Study
- ClinicalTrials.gov ID
- NCT07256626
- Acronym / sponsor ID
- 37378
- Conditions
- Pain, Back
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efforia, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Aug 2026 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Looking to support your back mobility and overall comfort? Join our study exploring WAVwatch 2.0, an innovative soundwave therapy device. This non-invasive technology is designed for individuals who want to maintain easy movement and flexibility without constantly reaching for over-the-counter options. By joining, you'll discover how this gentle approach may help support everyday back comfort, mobility, and flexibility.
Detailed description
This remotely administered decentralized trial is designed to methodically explore the efficacy of WAVwatch 2.0, a non-invasive device that leverages soundwave therapy, in enhancing back comfort and flexibility. In the wake of increasing reliance on temporary solutions for back tension and stiffness, this study emerges as a pivotal investigation into whether soundwave therapy can offer a sustainable pathway to maintaining ease of back movement and overall wellness.
The primary objective of this online trial is to facilitate participants in understanding the potential benefits of WAVwatch 2.0 on their daily comfort, range of motion, and general quality of life. Through this exploratory journey, participants will receive personalized insights, enabling a comprehensive understanding of how soundwave therapy might influence their back comfort and mobility. This initiative aims not only to assess the device's ability to support back wellness but also to empower participants with knowledge about alternative, non-invasive options for enhancing their quality of life.
Focusing on the experiential changes in ease of movement, daily activities, and overall wellness, the study intends to rigorously evaluate and document the impact of WAVwatch 2.0 on participants. By doing so, it seeks to offer a detailed perspective on the device's effectiveness in promoting back health and comfort. The trial is committed to providing participants with a clear, personalized overview of how soundwave therapy could integrate into their wellness routines, potentially redefining approaches to back care.
The significance of this remotely conducted trial extends beyond individual benefits, aiming to contribute to the broader understanding of non-invasive back care solutions. By examining the outcomes of using WAVwatch 2.0 for back comfort and mobility, the study aspires to challenge and expand current perspectives on managing back tension and stiffness, offering new insights into the role of soundwave therapy in daily wellness practices.
It is important to note that throughout this trial, the PROMISE and ROMISE scales will serve as key tools in assessing participants' quality of life, comfort, and ease of movement. These scales, while integral to evaluating the benefits of WAVwatch 2.0, are not utilized as diagnostic instruments but as means to gauge the subjective experience of participants, thereby enriching the study's findings on the feasibility of soundwave therapy as a supportive measure for back wellness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm observational where participants act as their own control
| Arm | Type | Receives |
|---|---|---|
| Single arm where participants act as their own control | Experimental | Device: WAVWatch 2.0Single arm where participants act as their own control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| WAVWatch 2.0The WAVwatch sound frequency therapy device employs acoustic waves absorbed through the skin to promote wellness, with manufacturers and users reporting minimal safety risks | Device | Single arm where participants act as their own control |
Primary outcome
PROMIS® Item Bank/Scale v.2.0 - Pain Behavior Survey
Time frame: Change from baseline (Day 1-3) in pain behavior at 4 weeks after the start of the intervention (Day 27-33)
This survey aims to understand individual behaviors and reactions when experiencing pain within the past 7 days.
Quality of Life and Health Survey
Time frame: Change from baseline (Day 1-3) in quality of life at 4 weeks after the start of the intervention (Day 27-33)
This survey asks about your feelings towards your quality of life, health, and various areas of your life. It covers your experiences and feelings in the past four weeks. Please choose the answer that appears most appropriate.
ROMIS® Numeric Rating Scale v.1.0 - Pain Intensity 1a
Time frame: Change from baseline (Day 1-3) in pain intensity at 1 week after the start of the intervention (Day 4-10)
This survey is designed to understand the level of pain experienced by the participant in the past 7 days. The responses will help in assessing the pain intensity from no pain to worst imaginable pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Additional information and join instructions on EfforiaLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAVWatch 2.0 in people with Pain, Back, run by Efforia, 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 3 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 26 Dec 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
PROMIS® Item Bank/Scale v.2.0 - Pain Behavior Survey (time frame: Change from baseline (Day 1-3) in pain behavior at 4 weeks after the start of the intervention (Day 27-33)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.