30 Day
Tune Up Your Back: Soundwave Wellness Study
| STUDY TITLE | Tune Up Your Back: Soundwave Wellness Study |
|---|---|
| Submitted under umbrella | |
| Date submitted |
May 2, 2025 |
| End date |
There is no pre-specified end date and sub-studies remain open long-term. |
| Language |
English |
| Efforia AI IRB approval recommendation | |
| Recruitment page preview | |
| Author edit | |
| Informed consent | |
| Study author |
Linda Bamber, Joseph Bamber, John Bamber, Matthew Amsden, Darci Gross |
| Principal investigator |
Matthew Amsden |
| Sub-Investigator for Adverse Events |
Dr. Viral Patel |
| Description |
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. |
| Participant engagement length |
30 Days |
| Sponsor |
This study is made possible by your payment to cover all supplies and expenses required to participate. |
| Cost to participant |
$597 |
| Included products & services |
WAVwatch 2.0 – Graphite: $697
|
| Outcome measures |
PROMIS® Item Bank/Scale v.2.0 – Pain Behavior Survey Quality of Life and Health Survey ROMIS® Numeric Rating Scale v.1.0 – Pain Intensity 1a |
| Methodology |
Single Arm longitudinal where participants act as their own control |
| Basic or advanced dissemination plan |
Basic |
| Deviation from recruitment approach |
No |
| Deviation from statistical approach |
No |
| Will study include “more about you questions” |
No |
| Clinicaltrials.Gov |
Yes |
| Committment to list findings on clinicaltrials.Gov |
Yes |
Preview This document is prepared with the assistance of AI, but is reviewed by a human.
Rational & Study Design
Why I created this study:
Back pain, even the minor aches and pains we all get is a drag. It often lingers just below the threshold of clinical intervention, leaving many to grapple with discomfort. While folklore and social media abound with miracle cures, scholarly research suggests non-invasive methods can offer genuine relief. The WAVwatch 2.0 leverages cutting-edge soundwave technology. This study is crucial to validate its efficacy, offering a potential breakthrough for countless individuals seeking a respite from their persistent, yet manageable, back pain.
My Objective for You:
Our goal is to explore the potential of WAVwatch 2.0 as a non-invasive alternative to traditional minor back pain. By participating, you'll gain insights into the device's impact on your pain behavior and quality of life. This personalized data will empower you to make informed decisions about managing your back discomfort without relying on over-the-counter solutions - or overkill from the pharmacy.
Aims & Objectives:
This study aims to evaluate the effectiveness of WAVwatch 2.0 in reducing back pain intensity and improving quality of life for participants. You will receive personalized results, revealing how this innovative soundwave therapy device influences your pain management journey. This valuable information will guide your future decisions on non-invasive pain relief solutions, optimizing your time and financial investments.
Significance & Impact:
The significance of this study lies in its potential to revolutionize non-invasive pain management strategies. By offering empirical evidence on the efficacy of WAVwatch 2.0 in alleviating minor back pain, we aim to fill a gap in current pain management options - maybe even studies exploring whether this device can help people with more serious back pain. While limitations may include variability in individual responses, the expected outcome is a validated, accessible alternative that empowers participants to manage their pain more effectively, transforming their quality of life.
The Intervention
Included Products & Services
Product Name: WAVwatch 2.0 – Graphite
Quantity included: 1
Price: $697.00
Product Description: Everything in the universe (and your body) vibrates at a unique frequency. Research also suggests that action of nerves is based on sound pulses. Sound frequencies may help restore harmony through gentle, non-invasive energy. WAVwatch 2.0 can be used for Soreness Better Sleep Energy Relaxation Detox Weight Management Mental Clarity Emotions Stress Swollen Joints WAVwatch makes self-care effortless—just wear it and let the frequencies play!
Product Image:
Ingredients: Internal Use Only
Product Safety:
**Product Title:** WAVwatch 2.0 – Graphite Edition
**Product Description:**
Introducing the WAVwatch 2.0 – Graphite Edition, a revolutionary wearable device designed to harness the power of sound frequencies to promote wellness and enhance your quality of life. Drawing on the fascinating concept that everything in the universe, including the human body, vibrates at unique frequencies, WAVwatch 2.0 offers a holistic approach to health and wellbeing.
**Key Features:**
- **Holistic Health Tool:** Utilizes sound frequencies to help restore the body's natural harmony, influenced by ongoing research into the bioacoustic impact of nerve actions.
- **Versatile Applications:** Designed to assist with a range of physical and mental conditions including soreness, sleep disturbances, energy levels, relaxation, detoxification, weight management, mental clarity, emotional balance, stress reduction, and swollen joints.
- **Non-Invasive Therapy:** Offers a gentle, non-invasive form of energy therapy that works by merely wearing the device, allowing the embedded technology to interact naturally with your body's frequencies.
- **User-Friendly Design:** The sleek, modern Graphite design is not only stylish but also comfortable and discreet enough to wear all day, every day.
- **Ease of Use:** With simplicity at its core, the WAVwatch 2.0 requires no complex setup or maintenance. Simply put it on and let it work its magic.
**Benefits:**
- **Self-Care Simplified:** WAVwatch 2.0 makes maintaining daily wellness as easy as wearing a watch. It's designed for anyone seeking a natural boost to their body’s ability to heal and maintain balance.
- **Science-Backed Approach:** Inspired by cutting-edge research in the field of bioacoustics, the WAVwatch 2.0 taps into the natural science of sound frequencies to support your body's health.
- **Suitable for Everyone:** Whether you're an athlete looking to speed up recovery, a busy professional needing stress relief, or anyone in between, WAVwatch 2.0 is your partner in personal health and wellness.
Embrace the future of self-care and experience a new level of well-being with the WAVwatch 2.0 – Graphite Edition. Just wear it and let the frequencies play their part in your journey towards a healthier, more balanced life.
The WAVwatch sound frequency therapy device employs acoustic waves absorbed through the skin to promote wellness, with manufacturers and users reporting minimal safety risks. Below is a detailed safety and side effect profile based on available information:
Safety Profile
Design Safety
Non-invasive & drug-free: Uses low-wave acoustic frequencies absorbed through the skin and bones, avoiding synthetic electromagnetic fields or internet connectivity.
Water-resistant (not waterproof): Suitable for light exposure but not submersion.
No interference with medical devices: Reported compatible with pacemakers and grounding pads due to acoustic (not electrical) frequencies.
Precautions
Avoid during high-intensity activities or excessive sweating to prevent damage.
Adjust volume to levels 1–3 (or 4–8 per some guides) for safe absorption.
Not FDA-approved; labeled experimental and non-medical.
Contraindications
Known allergies to metals and plastics used in connected health devices.
Pregnancy: Consult a physician before use.
Metallic implants/prosthetics: Caution advised for sound therapy (specific to singing bowls in sources).
Sound-induced epilepsy: Potential risk with sound vibrations.
Reported Side Effects
Manufacturers and most users claim no adverse effects, even with incorrect frequency selection. However:
Minor discomfort: Rare reports of temporary tingling or warmth during use (implied in general sound therapy context).
Warranty & Damage Risks
Covers defects for 1 year; optional extended warranty for accidents, spills, or screen damage.
Excludes theft, loss, or shipping-related issues.
Key Considerations
Individual variability: Effectiveness and tolerance may vary; users are advised to test frequencies cautiously.
Hydration: Recommended to drink water during sessions to aid frequency absorption.
The WAVwatch is marketed as low-risk, but users should consult healthcare providers for specific medical conditions and adhere to usage guidelines.
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Based on the provided risks, informed consent, intervention, and outcome measures, here is a table identifying the kinds of individuals who should avoid participating in this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with severe or chronic skin conditions | Risk of skin irritation or allergic reaction | The device may exacerbate skin issues due to potential irritation or allergic reactions. |
| Individuals with severe back pain | Exacerbation of existing back pain | The use of the device may worsen the condition instead of alleviating it. |
| Individuals prone to headaches or dizziness | Headaches and dizziness | The device may induce or worsen these symptoms, affecting the individual's well-being. |
| Individuals with mood disorders | Mood changes, frustration, and irritation | Potential mood changes and frustration could exacerbate existing mental health conditions. |
| Individuals with cognitive impairments | Cognitive impairment | Temporary distraction or discomfort could further impact cognitive function. |
| Individuals with respiratory conditions | Breathing or respiratory issues | Although not typically associated, any such occurrences should be taken seriously. |
| Pregnant individuals | Unknown risks to pregnancy | Limited research data could imply unforeseen risks during pregnancy. |
These groups should consider their unique health circumstances and consult with a healthcare professional before deciding to participate in the trial.
Study Design & Experience
Daily Activity: Use the WAVwatch 2.0 with the 'Pain > Back Support Frequency' every day to support your back, particularly after sitting too long, during physical strain, or when discomfort arises.
Assesments and frequency:- Daily: Mentally check in with how your back feels.
- Throughout the study: Complete the PROMIS® Item Bank v.2.0 – Pain Behavior Survey, Quality of Life and Health Survey, and PROMIS® Numeric Rating Scale v.1.0 – Pain Intensity 1a as specified in the protocol.
The study titled "Wave Goodbye to Back Pain: Sound Relief Study" aims to explore the potential benefits of the WAVwatch 2.0, a soundwave therapy device, in alleviating minor back pain. This study is designed as a single-arm observational trial where participants act as their own control, a methodology referred to at Efforia as a "Signal Phase" study. The primary objective is to assess whether the non-invasive WAVwatch 2.0 device can serve as an effective alternative to over-the-counter painkillers for individuals experiencing minor back discomfort. By using soundwave therapy, the study seeks to determine the device's efficacy in providing relief from common back aches and pains.
In this study, participants will engage with the WAVwatch 2.0 over a period of 30 days, adhering to a structured protocol that includes using the "Pain > Back Support Frequency" daily. The study experience is structured to ensure that participants gain personalized insights into the effectiveness of the device for their individual needs. Participants will be encouraged to synchronize their study activities with tools like Google Calendar and Todoist to facilitate adherence to the protocol. The study emphasizes the importance of consistent device usage to gather valuable data that can inform smarter decisions about back pain management strategies. Participants' privacy is prioritized, and the study aims to provide them with a clear understanding of what interventions are worthwhile.
The study employs various measures to track participant progress and outcomes, including the PROMIS® Item Bank v.2.0 – Pain Behavior Survey, Quality of Life and Health Survey, and PROMIS® Numeric Rating Scale v.1.0 – Pain Intensity 1a. These assessments will help in evaluating the impact of the WAVwatch 2.0 on participants' pain levels, behavior, and overall quality of life. Should the study yield a positive signal indicating the WAVwatch 2.0's effectiveness, it could pave the way for more robust study designs in the future. Furthermore, this trial will contribute to gathering comprehensive safety data, which is currently limited, thereby enhancing our understanding of the device's potential benefits and risks. For more detailed information on the study's methodology and design, please refer to the "Minimal Risk Umbrella protocol."
Statistical Analysis Plan
In alignment with the Minimal Risk Umbrella protocol, we have ensured that our statistical plan is consistent with the guidelines and framework established within this protocol. Our study involves non-invasive interventions and surveys that are designed to assess pain behavior, quality of life, and pain intensity, which fall under the minimal risk category.
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, we acknowledge and address several inherent limitations associated with the study design. Primarily, the absence of a control group introduces potential biases, such as placebo effects and participant expectations that could skew outcome interpretations. To mitigate this, the study incorporates an expectations questionnaire to quantify and account for such biases, providing a clearer picture of the WAVwatch 2.0's true efficacy on back pain management. Our design leverages the Minimal Risk Umbrella Protocol's emphasis on democratizing clinical research, ensuring we explore and validate research questions and interventions that might otherwise remain uninvestigated.
Another limitation pertains to the variability in individual responses to the WAVwatch 2.0 due to differences in demographics and baseline pain experiences. Our study addresses this by implementing a robust statistical methodology, including potential stratification by participant demographics, which enhances the accuracy of our data interpretation. The single-arm design, while less rigorous than randomized controlled trials, serves as an effective preliminary exploration—functioning as a signal detection study. This approach allows us to identify promising trends that can inform the necessity and design of subsequent, more controlled studies to rigorously test the device's efficacy.
Finally, the study's focus on a consumer-paid model ($597 for materials) poses financial accessibility concerns, potentially limiting participant diversity. However, by recruiting through various channels such as the Efforia website and social media, we broaden accessibility, enhancing participant diversity and the generalizability of findings. The inclusion of unlimited participants over an extended recruitment period further supports this effort. Should the WAVwatch 2.0 demonstrate positive outcomes in this initial phase, more inclusive, funded research could follow (including on more clinically relevant back pain that would require an IDE), in alignment with Efforia's mission to democratize clinical research, by offering verified non-invasive back pain management solutions to a wider audience. For more detailed information and to understand the broader context of this approach, individuals are encouraged to consult the Minimal Risk Umbrella Protocol.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The "Wave Goodbye to Back Pain: Sound Relief Study" appears to be suitable under the minimal risk umbrella protocol based on the guidelines provided. The study seems to focus on a non-invasive intervention—sound therapy—which is generally recognized as safe and does not require a physician's diagnosis or prescription. As it aims to explore the effects of sound-based interventions on general wellness and potentially enhance productivity and health within normal ranges, it aligns with the focus on health and wellness without crossing into regulated medical interventions. Furthermore, if the study involves longitudinal elements lasting several days and limits specimen collection to two or fewer blood draws, it would meet the criteria for minimal risk studies.
However, it is essential to ensure that the study does not inadvertently involve vulnerable populations or require any form of regulatory approval. Assuming the sound therapy intervention is not classified as a medical device or subject to sports regulatory body approval, the study should comply with the stipulations of not exceeding minimal risk. Additionally, the study should not incorporate blinding, deception, or specific eligibility criteria beyond basic accessibility, which appears to be in accordance with the guidelines if these elements are not present. If these conditions are met, the protocol is indeed suitable for inclusion under the minimal risk umbrella protocol.
Suitability for Pay to Participate Model
The WAVwatch 2.0 – Graphite, as utilized in the "Wave Goodbye to Back Pain: Sound Relief Study," is a product that is legally available on the open market in the United States, where soundwave therapy devices are commonly sold for personal health management. Consumers in the target market for non-invasive pain relief solutions are generally willing to pay for such products, as they often seek alternatives to pharmaceutical interventions. The $597 price point is consistent with similar therapeutic devices available in the market, and it reflects the costs associated with research, development, and production of the WAVwatch 2.0. Furthermore, the study offers participants the opportunity to access a product that not only provides soundwave therapy but also includes the added value of contributing to scientific research, potentially leading to improved and validated treatment protocols for minor back pain.
Participants in the "Wave Goodbye to Back Pain: Sound Relief Study" are likely to be typical consumers who prioritize non-invasive pain relief solutions and can financially manage the cost of the WAVwatch 2.0 without experiencing significant financial hardship. The study's design ensures transparency and informed consent, empowering participants to make autonomous decisions about their involvement. Additionally, the device's availability and use in the study offer real-world representation of its potential benefits, aligning with Efforia's commitment to enhancing beneficence and justice. Given the non-invasive nature of the device and the voluntary nature of participation, there is minimal risk of severe and acute vulnerabilities leading to significant buyer's remorse. Participants are fully informed about the study's objectives and the product's capabilities, allowing them to make educated choices about their participation and investment.
Human Subjects Protection Questionnaire
Beneficence
Is there a description, unambiguous research question, and purpose? Yes, the study has a clear research question and purpose, focusing on assessing the effectiveness of a specific product or service, which is defined in the study design. This clarity helps ensure that the study is well-directed and the data collected will address the intended objectives.
Is the study built on what is known already? Yes, the study builds on existing knowledge by examining a product or service that is currently available on the market. This foundation allows the study to contribute additional insights and potentially enhance understanding of the product's effectiveness or safety.
Will the study provide meaningful answers to the research question? Yes, the study is designed to produce meaningful results that are not only generalizable but also relevant to the individual participants. By assessing the product's impact in a real-world setting, the study can provide valuable information to both the participants and the broader community.
Will the study provide valid answers to the research question? Yes, the study's methodology is structured to ensure valid results, utilizing appropriate data collection and analysis techniques to accurately measure the product's effects. This approach helps ensure the reliability and credibility of the study's findings.
Non-maleficence
Are participants recruited with justifiable inclusion and exclusion criteria? Yes, any individual who has already purchased the product is eligible to participate, ensuring a relevant participant pool. Efforia emphasizes participant responsibility for assessing their suitability for the study through informed consent, which outlines potential risks and special considerations.
Does the research team have the experience, skills, facilities, and time to complete the study? Yes, the research team is well-equipped to conduct the study, with extensive infrastructure provided by the Efforia platform and the expertise of the Principal Investigator, Matthew Amsden. The study is decentralized and minimal risk, reducing the likelihood of adverse events, and Dr. Viral Patel is available to address any issues that arise.
Is there a fair balance of benefits and harms (risks) for all with an interest in the study? Yes, the study's unique approach offers added value to participants by providing insights at no additional cost, alongside the minimal risk nature of the interventions. The design ensures that benefits outweigh potential risks, making participation advantageous.
Will participants receive appropriate care both during and after the study? Yes, participants are advised to seek their own medical care in the event of an adverse event, as outlined in the informed consent. The minimal risk nature of the study and ongoing monitoring offer more care than would typically be available outside the study.
Is personal data handled appropriately (confidentiality)? Yes, personal data is managed in accordance with the Minimal Risk Umbrella protocol, ensuring confidentiality and compliance with ethical standards.
Autonomy
Have participants been offered a fair choice through the information they are given (presented in plain English) and consent process? Yes, the informed consent document clearly outlines the study's details, risks, benefits, and voluntary nature, empowering participants to make informed decisions about their involvement.
Has the research incorporated patient and participant views? Yes, Efforia's platform is inherently participant-driven, incorporating participant feedback into study design. This study encourages participants to provide input and ask questions, ensuring their perspectives are considered.
Justice
Are there fair payments for participation and financial recompense in case of harm? Yes, while participation involves a cost, the study offers valuable insights and health outcome tracking. In case of harm, participants are responsible for their own medical expenses but are instructed to report incidents for further action by Efforia.
Do participants have access to an independent complaints procedure (or advocate)? Yes, participants can contact Efforia's support for concerns, or reach out to independent ethics review boards, whose contact information is included in the informed consent, ensuring access to impartial resolution avenues.
Will the project be registered and results reported in the public domain? Yes, Efforia is committed to transparency by making personal results available to participants and publishing generalizable results to build credibility and contribute to the public domain.