. 2023 Jan 27;24(Suppl 1):S126–S138. doi: 10.1093/pm/pnad005

Table 1.

Light phenotyping inclusion and exclusion criteria

Inclusion Criteria	Exclusion Criteria
Meet the definition of cLBP described in the NIH Task Force Report on Research Standards for Chronic Low Back Pain. ie, low back pain presents at least six months, and presents more than half of those days. Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference. The normal population mean for pain interference is 50. Participants must be 1 SD above the population mean (≥60) for inclusion. Individuals must be willing and eligible to be randomized to receive at least three of the four proposed treatments.	History of: discitis osteomyelitis (spine infection) or spine tumor ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus cauda equina syndrome or spinal radiculopathy with functional motor deficit Diagnosis of any vertebral fracture in the last 6 months Osteoporosis requiring treatment other than vitamin D and calcium supplements Cancer (History of any bone-related cancer or cancer that metastasized to the bone; currently in treatment for cancer or plan to start treatment in the next 12 months; history of any cancer treatment in the last 24 months) Life expectancy less than 2 years Unable to speak and write English Visual or hearing difficulties that would preclude participation Presence of any history that would preclude scanning in MRI Uncontrolled drug/alcohol addiction Individuals started receiving disability or compensation within the past year, or currently involved in litigation Pregnancy or breastfeeding Individuals on high doses of opioids (over 100 OME per day) Scheduled back surgery, back surgery within the last year, or more than one back surgery in the past. Expecting to receive an injection or surgical procedure within the next year for their cLBP Current/planned (next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial. Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

Inclusion Criteria

Exclusion Criteria

Meet the definition of cLBP described in the NIH Task Force Report on Research Standards for Chronic Low Back Pain. ie, low back pain presents at least six months, and presents more than half of those days.
Individuals must have a pain interference score of ≥60 on PROMIS Pain Interference. The normal population mean for pain interference is 50. Participants must be 1 SD above the population mean (≥60) for inclusion.
Individuals must be willing and eligible to be randomized to receive at least three of the four proposed treatments.

History of:
- discitis osteomyelitis (spine infection) or spine tumor
- ankylosing spondylitis, rheumatoid arthritis, polymyalgia rheumatica, or psoriatic arthritis, lupus
- cauda equina syndrome or spinal radiculopathy with functional motor deficit
Diagnosis of any vertebral fracture in the last 6 months
Osteoporosis requiring treatment other than vitamin D and calcium supplements
Cancer (History of any bone-related cancer or cancer that metastasized to the bone; currently in treatment for cancer or plan to start treatment in the next 12 months; history of any cancer treatment in the last 24 months)
Life expectancy less than 2 years
Unable to speak and write English
Visual or hearing difficulties that would preclude participation
Presence of any history that would preclude scanning in MRI
Uncontrolled drug/alcohol addiction
Individuals started receiving disability or compensation within the past year, or currently involved in litigation
Pregnancy or breastfeeding
Individuals on high doses of opioids (over 100 OME per day)
Scheduled back surgery, back surgery within the last year, or more than one back surgery in the past.
Expecting to receive an injection or surgical procedure within the next year for their cLBP
Current/planned (next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

1. Deyo RA, Dworkin SF, Amtmann D, et al. Report of the NIH Task Force on research standards for chronic low back pain. J Pain. 2014; 15(6):569–585.