We’re looking to create the next generation of digital therapies for chronic neck pain, and we’d like you to get involved.
Please email email@example.com or call (855) 902-2777 if you would like to opt out of research after finishing your program application.
Digital Care Pathways for Musculoskeletal Disorders
TITLE: Digital Care Pathways for Musculoskeletal Disorders: a pilot study to determine the efficacy of digital care pathways for chronic pain.
WIRB® Protocol #20160949
SPONSOR: Hinge Health, Inc.
INVESTIGATOR: Gabriel Mecklenburg, MA
465 California Street, Floor 14 San Francisco, California 94104 United States
STUDY-RELATED PHONE NUMBER(S): Gabriel Mecklenburg, + 1 (855) 902-2777 (24 hours)
“A pilot study to determine the efficacy of digital care pathways for chronic neck pain.”
You are invited to participate in a medical research study, and help in the development of the next generation of digital health care for chronic neck/upper back pain. We’re looking to redefine the delivery of best-practice care for chronic neck/upper back pain. Right now the best available care for chronic neck/upper back pain involves:
Learning about the condition
We believe that technology has a big potential to improve the delivery of this care for patients. So, we are inviting you to participate in a study to help us determine the efficacy a digital care pathway for treating neck/upper back pain. The effectiveness of the digital delivery of care is investigational. The important things to know are that:
You can withdraw from the study at any time without affecting your access to care.
You may continue in the program as long as it is offered by your employer or other host organization. We will check in with you at 6 months, one year and two years after you discontinue to see how you’re doing.
Please take your time to read the information in this leaflet and consider taking part in this study.
Background: Causes and Treatment for Neck/Upper back Pain
Chronic neck/upper back pain may originate from various causes, including wear and tear (osteoarthritis), myofascial pain, disc problems, pinched nerves, strains, sprains, or other injuries. It often involves difficulty moving the neck or upper back, stiffness, and pain in the neck, upper back, shoulder and/or arm. There are a wide range of factors that can contribute to the development and severity of chronic neck or upper back pain including: age, gender, genetics, activity level, posture, movement patterns and prior injuries. Importantly, however, chronic neck pain is a condition that you can take active control of, resulting in significant improvements in pain and function.
To achieve this, you will need to:
Learn more about the condition, how to manage it, and what to avoid
Participate in exercise therapy to make your neck and upper back stronger and more flexible
Make certain lifestyle changes, for example to diet and activity levels
This may reduce your need for pain-killers and also delay or even avoid the need for surgery later in life.
Why are we carrying out this study?
This research is important because the best-practice care recommended for chronic neck/upper back pain can be difficult and expensive to deliver. As a result, it is not possible for many people to access the level of care recommended in the medical literature. Developing better ways to deliver that care is, therefore, a critically important objective.
Hinge Health, the study sponsor and a developer of digital care pathways for musculoskeletal disorders, has carried out several trials previously. The results indicate that digital care delivery can be an effective means of reducing pain and stiffness while increasing function. This study intends to expand that evidence while refining the structure and delivery of the program to participants.
Gabriel Mecklenburg has equity and receives compensation from the sponsor. Please feel free to ask any further questions you might have about this matter.
Why am I being invited to participate in this study?
We are inviting you to participate because, based on your responses to our screening questionnaire, your neck or upper back pain symptoms may be conducive to the treatment available through Hinge Health’s digital care pathway. Further, you do not have other medical conditions that would preclude your participation.
However, before agreeing to participate you should confirm that:
You have regular access to Wi-Fi
You are reasonably comfortable using a tablet computer (we will provide you with the tablet), or are happy to learn
You are open to adopting lifestyle changes necessary to manage and reduce your neck or upper back pain
This is important to make sure that you will receive the maximum benefit from the care delivered as part of the study. If you have any questions about these requirements do not hesitate to ask a representative from Hinge Health.
However, it is important to know that, because we do not conclusively know if Hinge Health’s digital care pathway is better than the currently available healthcare options, we need to compare the two. To do this, we will put people taking part in this research into two groups. The groups are selected by chance, as if by tossing a coin.
Participants in the first group will be given access to Hinge Health’s digital care pathway (details below) while participants on the second group will be placed on a waitlist and will continue to have access to the existing healthcare options under their insurance plan, minus Hinge Health. We will then compare the outcomes of the two groups to determine the effect of the program. We will contact you after one and two years for follow up. Participants who agree to remain on the waitlist will be given priority access to future deployments of Hinge Health with your employer or host organization.
What is my alternative?
Your alternative is not to participate.
What will happen if I participate?
This section describes the treatment intervention you will receive as part of Hinge Health’s program. It is important for you to review and understand the information below to make sure you are comfortable committing to the study.
Step 1: Receive Your Hinge Health Kit
After confirming your participation in the program, Hinge Health will provide you with a program toolkit including a tablet computer and wearable sensors. You will use the tablet to access Hinge’s mobile health application, which will be your primary destination for exercise therapy, educational content and coach interaction throughout the program. The wearable sensors will provide real-time feedback during your exercise therapy and assist in guiding you through the exercises.
Step 2: The App Tutorial
Once your kit arrives, you’ll be guided through an in-app tutorial on the tablet. This will help you get oriented to the program and teach you how to use your sensors.
Step 3: Chat With Your Coach
Next, you’ll go through your first online coaching session and have the opportunity to speak on the phone with your personal coach. Your coach will be primarily responsible for customizing the program to your needs and goals and assisting you through the program.
Step 4: Get Started!
At that point you’ll be ready to get started with the program. Your coach will continue to work with you throughout and Hinge will follow up at various points during and after the program to find out how you are doing.
By proceeding with my application, I agree that:
I confirm that I have read the above information sheet.
I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected and without penalty or loss of benefits to which I am otherwise entitled.
I understand that the information I provide during my participation in the study, as well as information logged during my used of Hinge Health’s mobile application, may be viewed by employees of Hinge Health and, in aggregated form, by the organization offering Hinge Health. I give permission for these individuals to have access to these records.
I understand that the information collected about me will be used to support other research in the future, and may be shared in an anonymized form with other researchers.
I agree to take part in the above study.
If you are agreeing to this form after having already begun the Hinge Health program, you agree that we may use any data that we have already collected from you. However, if you do not agree to allow previous data collected to be used, you cannot be in this study.
If you have agreed to participate in this study previously, you are not under any obligation to continue your participation by agreeing to this consent.
Frequently Asked Questions
What are the possible benefits of taking part?
The benefits from receiving best practice care, whether digitally or in-person, may include reduction in neck or upper back pain, reduction in stiffness, improvement in function, and (if appropriate for you) some modest weight loss. You may also find that your mood and general wellbeing improve. However, the effects vary from person to person, and you may not experience substantial improvements. You may not receive any benefit for being in the study.
What are the possible disadvantages and risks of taking part?
Participating in the study does not present substantial risk. Participating in exercise therapy may lead to some temporary pain and discomfort. There may be a loss of confidentiality for being in this study.
If, for whatever reasons, you unexpectedly experience any ill effects, your care provider may recommend you withdraw from the study.
If you have a concern about any aspect of this study, you should speak to a member of the research team who will do their best to answer your questions. They may be contacted at: (855) 902-2777 or firstname.lastname@example.org.
Will my data be kept confidential?
The confidentiality of your data is extremely important to us but can’t be guaranteed. The sponsor of this study, Hinge Health, ensures that the handling, processing, storage and destruction of data complies will all applicable laws, rules and regulations. The information may also be given to the U.S. Food and Drug Administration (FDA). It may be given to similar governmental agencies in other countries. Medical records which identify you and the consent form signed by you may also be looked at and/or copied for research or regulatory purposes by:
Department of Health and Human Services (DHHS) agencies,
the institution where the research is being done, and
Western Institutional Review Board® (WIRB®).
Any data publicized based on this study will be made available only in anonymized form.
Will you inform my doctor?
No. Neither Hinge Health nor the organization offering Hinge Health to you will contact your doctor regarding participation in this study.
Will I receive painkillers or medication during the study?
Medication is not part of the care for this study. However, you may still participate if you are on medication such as painkillers.
What will happen if I don’t carry on with the study?
You can withdraw from the study at any time and without any repercussions. We may still use data collected in our research, but it will be anonymized and not linked to your personal information.
What will happen to the results of the study?
Results of this study will be published to the wider scientific community to advance knowledge regarding chronic neck/upper back pain treatment programs. You will not be identified in any publication, as we will be using the collective data of all participants.
How is the study organized and funded?
This study has been designed by Hinge Health, the digital health company (founded by Oxford and Cambridge researchers) that designed the digital care pathway used in this study. Hinge Health is being paid by your employer or other host organization to provide this care opportunity. This research study is being thoroughly reviewed by an independent group called an Institutional Review Board. The reference number given by the committee for this study is shown at the top of this page of this information sheet.
Will I be paid for being in the study?
You will not be paid for being in the study.
What if there are new findings?
You will be notified if new information that becomes available that may affect this study.
Is there a cost for being in this study?
There is no cost to you for being in the study.
Further Information and Contact Details
For information about the research, please visit www.hingehealth.com. For questions concerns or complaints about the study, or if you feel you have experienced a research- related injury contact the principal investigator, Gabriel Mecklenburg at email@example.com / +1 (855) 902-2777 (24 hours).
If you have questions about your rights as a research subject or if you have questions, concerns, or complaints about the research, you may contact:
Western Institutional Review Board® (WIRB®) 1019 39th Avenue SE Suite 120 Puyallup, Washington 98374-2115 Telephone: 1-800-562-4789 or 360-252-2500 E-mail: Help@wirb.com
WIRB is a group of people who perform independent review of research.
WIRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.