Tune Up Your Back: Soundwave Wellness Study
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New York
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New York, New York, United States, 10003
- Efforia
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm where participants act as their own control
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The WAVwatch sound frequency therapy device employs acoustic waves absorbed through the skin to promote wellness, with manufacturers and users reporting minimal safety risks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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
Time Frame: Change from baseline (Day 1-3) in pain intensity at 1 week after the start of the intervention (Day 4-10)
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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.
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Change from baseline (Day 1-3) in pain intensity at 1 week after the start of the intervention (Day 4-10)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37378
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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