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Table 1 Study inclusion and exclusion criteria

From: Study protocol for patient response to spinal manipulation – a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain

Inclusion criteria Rationale Source
Age ≥ 21 and ≤ 65 Chronic LBP not as common under age 21. Older adults not as likely to tolerate biomechanical tests PS, BL1
Chronic low back pain matching QTF Classifications 1, 2, and 3 Low back pain, uncomplicated by known nerve root compression, neurological signs or prior surgery CR
RMDQ ≥ 6 Disability high enough to prevent floor effect PS
NRS Pain (Average within past 24 hours) ≥ 2 at PS and BL1 and BL2, and ≥ 4 at PS or BL1 Pain high enough to prevent floor effect PS, BL1, BL2
Exclusion criteria   
Additional diagnostic tests or urgent/emergent procedures needed beyond study exam procedures Advanced diagnostic tests or other necessary evaluation(s) are outside study scope CR
BMI ≥ 40 Unable to adequately perform manipulation procedures per study protocol BL1
BDI II score ≥ 29 May interfere with protocol compliance and data collection BL1
Compliance concerns May compromise ability to comply with study protocols CR
Co-morbidity requiring coincident clinical management May interfere with study requirements, pose significant scheduling burden, or pose a safety risk CR
Inability to read or verbally comprehend English Proxy unavailable BL1
Inflammatory or destructive tissue changes to the spine Potential intolerance to biomechanical testing or treatment protocols PS, CR
Joint replacement history Potential intolerance to biomechanical testing or treatment protocols PS, CR
Moving from area within 8 weeks May interfere with ability to comply with study protocol PS, BL1, BL2
Neuromuscular disease Interference with biomechanical measurements PS
No indication for SM at L1 – L5 or sacroiliac joint (s) Spinal Manipulation is only treatment available CR
Open or pending litigation for LBP or seeking/receiving disability compensation May interfere with study compliance or data collection PS, BL1
Pacemaker/Defibrillator Safety due to potential electromagnetic fields produced by biomechanical testing equipment PS, BL1
Peripheral arterial disease Potential intolerance to biomechanical tests, potential need for referral, and interference with pain and disability measures PS, CR
Pregnancy Safety for biomechanical testing and may interfere with data collection PS, BL1
QTF classification 4-11 Conditions sufficiently complicated to cause intolerance to biomechanical testing procedures or data collection CR
Received SM within past 4 weeks May interfere with data interpretation BL1
Safety Precaution for condition(s) posing a safety risk or intolerance for treatment or biomechanical tests (i.e., excessive bruising/bleeding and adhesive sensitivity) CR
Suspicion of drug or alcohol abuse May interfere with data collection, ability to comply with study protocol, and require referral CR
Uncontrolled hypertension May interfere with study protocols and require referral CR
  1. BDI-II: Beck Depression Inventory; BL1: Baseline Visit 1; BL2: Baseline Visit 2; BMI: body mass index; CR: Case Review; L1 – L5: lumbar segment level 1 to 5. LBP: low back pain; NRS: numerical rating scale; PS: Phone Screen; QTF- Quebec Task Force; SM: Spinal Manipulation.