Biomarkers for Evaluating Spine Treatments

Official Title
A Study About Biomarkers for Evaluating Spine Treatments
Purpose

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