Table 2 Eligibility criteria determined during case review for Trial 2
Inclusion criteria | Rationale |
Low back pain diagnosis consistent with Quebec Task Force classifications 1 to 9 | Low back pain classifications commonly treated by both doctors of chiropractic and primary care physicians |
Exclusion criteria | Rationale |
Low back pain diagnosis consistent with Quebec Task Force classification of 10 or 11 | Classification 10 (chronic pain syndrome) and Classification 11 (other low back pain causes such as visceral disease, metastasis, and spondylitis) require treatment outside the scope of the trial |
Spinal surgery in past 3 months | Potential to confound health outcomes |
Fracture in any location in the body in 6 weeks | Recent fracture may influence ability to measure pain-related health outcomes; participant safety concern |
Active carcinoma/metastatic disease or current treatment for any form of cancer | Serious health condition requiring medical treatment during study period; participant safety concern |
Serious concomitant illness or co-morbidity preventing delivery of care of any available treatments | Potential to confound health outcomes |
Serious concomitant illness or co-morbidity requiring coincident medical treatment | May interfere with study requirements or pose a significant scheduling burden to participants during study period |
Contraindication to chiropractic care in primary treatment area | Safety precaution for treatment protocols |
Aortic aneurysm (or suspicion of) >5 centimeters | Safety precaution for treatment protocols; need for referral for further evaluation or treatment |
Need for advanced laboratory testing or diagnostic imaging or referral to a healthcare provider | Safety precaution for treatment protocols; potential need for further evaluation or treatment outside that provided by study protocol |
Other clinical concerns for safety of available treatments | Safety precaution for treatment protocols |
Activities of daily living, mobility, or sensory impairment | Severe impairments may pose a safety concern or impair delivery of available treatments in outpatient study facilities |
Cognitive or memory impairment | May prohibit informed consent or compromise safety due to potentially reduced comprehension or compliance with study procedures |
Suspicion of alcohol or drug abuse | May interfere with data collection, ability to comply with study protocol, and requires referral/management |
Compliance concerns | May compromise ability to adhere to study protocol |