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Table 2 Eligibility criteria determined during case review for Trial 2

From: Eligibility determination for clinical trials: development of a case review process at a chiropractic research center

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