Biomarkers for Evaluating Spine Treatments

Official Title
A Study About Biomarkers for Evaluating Spine Treatments

The purpose of this research study is to study four treatments for chronic low-back pain to learn whether or not certain treatments work better for people with certain characteristics.

The study’s main goal is to find a way to match treatments to low-back pain patients based on their characteristics and how they responded to treatments they have used before.

Could this study be right for you?

Inclusion Criteria:

To be eligible, an individual must meet all of the following inclusion criteria:

  • Ability to read and understand English
  • Provision of signed and dated informed consent form(s)
  • Willing and able to receive study-related messages and survey links via email
  • Willing and able to receive study-related phone calls
  • Age 18 years old or older
  • Low-back pain for at least 3 months and occurring on at least half the days in the past 6 months
  • Contraindicated to no more than one of the study interventions at the time of eligibility assessment(s)
  • Eligible to receive at least three of the four study interventions and willing to receive any intervention for which they are eligible
  • A PEG score 4 or higher at two time points: 1) screening prior to the Run-in period and 2) screening prior to baseline (Visit 0)
  • Willing and able to undergo required phenotyping
  • Regular reliable access to an internet-enabled device such as a smart phone, tablet, or laptop computer
  • Meet Run-in period engagement eligibility criteria:

    • Completion of two Run-in study information modules prior to period 1 randomization (Visit 0)
    • Response to at least 5 emails prior to period 1 randomization (Visit 0)
  • Low-back pain more severe than pain in other parts of the body
  • Available to complete the full study protocol (approximately 9 months)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnant at the time of Visit 0 (Baseline)
  • Affirmative participant response to any of the following conditions:

    • Progressive neurodegenerative disease
    • History of discitis osteomyelitis (spine infection) or spine tumor
    • History of ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, or lupus
    • History of cauda equina syndrome or spinal radiculopathy with functional motor deficit (strength <4/5 on manual motor testing)
    • Diagnosis of any vertebral fracture in the last 6 months
    • Osteoporosis requiring pharmacologic treatment other than vitamin D, calcium supplements, or bisphosphonates.
    • History of any bone-related cancer or cancer that metastasized to the bone
    • Currently in treatment for any non-skin cancer or plan to start non-skin cancer treatment in the next 12 months
    • History of any non-skin cancer treatment in the last 24 months
    • Visual or hearing difficulties that would preclude participation
    • Uncontrolled drug/alcohol addiction
    • Individuals actively pursuing disability or workers compensation or involved in active personal injury-related litigation
    • Currently participating in another interventional pain study
  • Any condition that, in the opinion of the investigator, would preclude the patient from being able to safely participate in in the trial
Age Range
18 and up

The Spine Project

Official Title
The Spine Phenome Project

This study is designed to capture information about your spine. We will collect information from wearable sensors while you move your low back and neck. We will also collect a series of questionnaires and information from your medical record that related to your spine health. We want to compare the health history and motion capabilities of participants with healthy spines to participants with back and neck pain disorders. We believe that capturing and analyzing this information together will advance our understanding of low back and neck disorders and help develop healthcare applications, tools, or devices that improve the way we prevent, evaluate, and treat spine disorders. You will complete up to 8 visits and participate in the study for up to 5 years.

Could this study be right for you?

To participate, you must meet the following criteria: -Age 18-80 -Able to speak, read, and understand English -Able to stand for 20 minutes Please let us know if you have any of the following as you may not be eligible to participate (not a complete list): -Currently pregnant -Currently seeing or planning to see a medical provider for low back or neck pain -History of chronic low back or neck pain lasting longer than 3 months -Severe back or spine curvature (example – scoliosis) -Current condition requiring a back brace -History of spine surgery -History of brain or spine cancer -Open wounds on back or neck -Current spine infection

Age Range
18 and up