Table 1.
Study inclusion and exclusion criteria
| 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 |
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.