Biomarkers for Evaluating Spine Treatments
Official Title
A Study About Biomarkers for Evaluating Spine TreatmentsPurpose
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