Summary Information to Help you Decide Whether to Join this Study

Study Title	Wave Goodbye to Back Pain: Sound Relief Awaits
Study Author	Joseph Bamber, John Bamber, Linda Bamber, Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$597
Included Products & Services	WAVwatch 2.0 – Graphite
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
Contact	help@efforia.com

Introduction & Summary

Welcome! You are invited to join our research study "Wave Goodbye to Back Pain: Sound Relief Awaits" on the Efforia platform. This study is made possible by your support through participation and financial contribution. Before you make your decision, consider this concise summary to understand why you might want to participate, or not, in this study. The purpose of this study is to evaluate the effectiveness of the WAVwatch 2.0 device in alleviating back pain. Your participation is entirely voluntary, and you can leave the study at any time without any penalty. If you have questions, please seek answers before proceeding.

Efforia is a citizen science platform where studies are effectively sponsored by you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

Purpose of the Study

The purpose of this study is to investigate the efficacy of the WAVwatch 2.0 device, a non-invasive wearable designed to alleviate back pain through sound frequency therapy. The study aims to contribute valuable insights into alternative pain management strategies, potentially benefiting individuals suffering from chronic back pain. Participants will use the WAVwatch 2.0 device, which emits specific sound frequencies aimed at reducing pain, and their experiences will be measured using the PROMIS® Pain Behavior Survey, Quality of Life and Health Survey, and the PROMIS® Numeric Rating Scale.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

It is important to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary, and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

No Benefit: A key risk to all studies is that there is no benefit, and that participants receive no benefit from the proposed intervention or treatment, despite the financial payment the participant has made.

There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Interventional New Drug Application: WAVwatch 2.0 – Graphite

Introduction

The WAVwatch 2.0 – Graphite is a non-invasive wearable device designed for sound therapy, specifically targeting the alleviation of back pain and enhancing quality of life. This report details the known risks and potential side effects associated with the use of WAVwatch 2.0, based on existing academic literature, anecdotal evidence, and user feedback from online forums and case reports.

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

In the Case of an Adverse Event

If you experience any adverse event while using the WAVwatch 2.0, seek immediate medical care by calling 911, especially if symptoms are severe or life-threatening. After addressing any acute situations, please contact Efforia to report the incident. Your feedback is crucial for ongoing safety monitoring and product improvement.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Exacerbation of existing back pain	Low to moderate likelihood	Symptoms usually subside with discontinuation
Skin irritation or allergic reaction	Low likelihood	Symptoms typically resolve after discontinuation
Headaches and dizziness	Low likelihood	Often subsides with continued use
Frustration and irritation	Very low likelihood	May persist as long as the device is in use

Other Known Risks

• Gastrointestinal Symptoms: Uncommon, and usually anecdotal. No clear evidence linking the use of WAVwatch 2.0 to gastrointestinal issues.
• Skin & Hair Reactions: Minor skin irritation has been reported, particularly at higher volume settings. Generally, symptoms resolve upon lowering the volume or discontinuing use.
• Mood Changes: Mood swings are rarely reported and typically associated with frustration due to non-responsiveness or ineffectiveness in some users.
• Cognitive impairment: No substantial evidence to suggest that WAVwatch 2.0 affects cognitive functions. However, distraction or discomfort might temporarily affect concentration.
• Breathing or respiratory issues: Not typically associated with WAVwatch 2.0. Any occurrences should be reported immediately as they might indicate an unrelated underlying condition.

Long-term Dependence

No evidence suggests that long-term dependence occurs with the regular use of WAVwatch 2.0. Users can stop using the device at any time without withdrawal symptoms, though underlying symptoms (e.g., back pain) may persist or return.

Legality and Compliance

The use of WAVwatch 2.0 should be compliant with local regulations and workplace policies. It is not listed by the World Anti-Doping Association (WADA) or the National Collegiate Athletic Association (NCAA) as a banned substance or method, making it generally permissible for athletes. However, individual users are encouraged to verify the acceptability of wearable therapeutic devices within their specific professional or athletic organizations.

Efforia's Limitations in Providing Direct Medical Support

While Efforia provides the platform for using WAVwatch 2.0, it does not offer direct medical services or emergency response capabilities. Users should maintain contact with their healthcare providers for medical advice and emergency services when necessary.

This document aims to assist in the informed use of WAVwatch 2.0 by highlighting potential risks and providing guidelines for action in the event of adverse effects. Ongoing monitoring and user feedback are essential for ensuring the safety and efficacy of this therapeutic device.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: https://efforia.com/privacy-policy/

There may be very certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury.

If you experience any problems, side effects, or study-related injury, please contact Efforia after you've received any necessary treatment. We want to make sure others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right, or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant

Ethical Considerations: Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance

Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections

Describe how data will be collected, used, and protected, ensuring compliance with data protection laws.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. There may be partners who also have access to your data (like labs and connected health devices).

What will we do with your data

We will use the data to show you your own personal results, and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

California Experiential Research Subject’s Bill of Rights

Tell participants about the California Experiential Research Subject Bill of Rights. Give participants a link to the Efforia privacy policy.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:
HELP@EFFORIA.COM
(646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road
Suite 403
Raleigh, NC 27612
info@univo-group.com
(919) 910-7743

Additional questions and closing

Efforia and Univo have approved the information in this consent form and have given approval to publish this study. This does not mean Efforia or Univo have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.
If you have questions, please contact help@efforia.com. It is up to you to do additional research and talk to your physician before joining a study.