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 knee pain and chronic lower back pain.

WIRB® Protocol #20160949

SPONSOR: Hinge Health, Inc.

INVESTIGATOR:    Gabriel Mecklenburg, MA
Suite 200, 818 Mission Street
San Francisco, California 94103
United States

STUDY-RELATED PHONE NUMBER(S): Gabriel Mecklenburg, +1 (415) 510-1419 (24 hours)

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 lower back pain.

“A pilot study to determine the efficacy of digital care pathways for chronic lower back pain.”

Summary

  1. The best available care chronic lower back pain involves
    1. learning about the condition,
    2. exercise therapy,
    3. behavioral changes.
  2. There is active interest in exploring how to use technology to improve the delivery of care for patients with chronic lower back pain.
  3. We are inviting you to participate in a study evaluating the provision of care for lower back pain through an integrated digital care pathway
  4. You can withdraw from the study at any time without affecting your access to care.
  5. The main study will take 12 weeks. We will check in with you at one and two years post-treatment to see how you’re doing.

Please take your time to read the information in this leaflet and consider this opportunity.

Chronic Lower Back Pain: Causes and Treatment

Your back is one of the strongest part of your body, containing the bones and flexible disks of the spine reinforced by multiple types of soft tissue, such as muscles, ligaments and nerves. Yet, back pain issues affect over 80% of people at some point in their lives, making it a leading cause of pain and disability worldwide.

Lower back pain, defined as pain occurring in the region between your rib cage and the top of your legs, is by far the most common type of back pain and affects both the young and old. Symptoms include tension, stiffness or soreness in this region. Chronic lower back pain is defined as that lasting more than 12 weeks and accounts for approximately 20% of all cases.

The causes of acute and chronic back pain vary but are generally caused by tissue sprains or strains. Often there is no specific cause identifiable, but the pain is real nonetheless. Back pain arising from more serious conditions, such as spinal damage, is typically associated with other symptoms such as incontinence or unexplained weight loss. We asked you about these ‘red flags’ during the screening process for this program because they are a sign that this program would not be appropriate for your needs.

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Even in cases of non-specific back pain, self-management techniques provide a powerful way to manage and reduce chronic lower back pain. This study is designed to help you self-manage your back pain by allowing you to:

  • Learn about the condition, how to manage it, and what to avoid,
  • Participate in exercise therapy that will strengthen the back,
  • 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 future medical interventions.

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Why are we carrying out this study?

This research is important because the best-practice care recommended for chronic lower 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 lower back pain and stiffness while increasing function. This study intends to expand that evidence while refining the structure and delivery of the program to participants.

Why have I been chosen?

We are inviting you to participate because, based on your responses to our screening questionnaire, your lower 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 back pain.

This is important to make sure that you will receive the maximum benefit from the care delivered as part of the study.

However, it is important to know that, because we do now 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. After the 12-week digital care pathway intervention we will compare the outcomes of the two groups to determine the effect of the program. Participants who agree to remain on the waitlist will be given priority access to future deployments of Hinge Health with your employer. 

What will happen if I take part?

This section describes the treatment intervention you will receive as part of Hinge Health’s 12-week program. It is important for you to review and understand the information below to make sure you are comfortable committing to the study.

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Step 1: Receive Your Hinge Health Toolkit

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: Schedule Your On-Boarding Session

Once receiving your Hinge Toolkit, you’ll go through a 30-minute session to introduce you to the mobile application and instruct you on proper use of the mobile sensors.

Step 3: Schedule Your Coaching Session

Next you’ll have the opportunity to speak with your personal Hinge coach, who will be primarily responsible for customizing the program to your needs and assisting you through the 12-week program. In this call you’ll discuss how Hinge’s mobile application and wearable sensors can help you:

  • safely and effectively carry out a set of customized at-home exercises for 10-15 minutes several times a week,
  • learn more about chronic lower back pain and how you can combat its symptoms,
  • achieve and/or maintain a healthy weight if this would help your condition,
  • talk to your “team”, a group of patients going through the program together with you, and to your personal health coach.

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 our how you are doing.

Consent

By proceeding with my application, I agree that:

  1. I confirm that I have read the above information sheet.
  2. 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.
  3. 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 my employer. I give permission for these individuals to have access to these records.
  4. 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.
  5. I agree to take part in the above study.

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 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.

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.

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 (415 510 1419) or hello@hingehealth.com.

Will my data be kept confidential?

The confidentiality of your data is extremely important to us. 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. Any data publicized based on this study will be made available only in anonymized form.

Will you inform my GP?

No. Neither Hinge Health nor your employer will contact your GP 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 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 organised 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 to provide this care opportunity to its employees. This research study is being thoroughly reviewed by an independent group called a Research Ethics Committee. The reference number given by the committee for this study is shown at the top of this page of this information sheet.

Further Information and Contact Details

For information about the research, please visit www.hingehealth.com or contact the principal investigator, Peter Smittenaar at peter@hingehealth.com / +1 (415) 510-1419

 

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.