Table 1.
Inclusion and Exclusion Criteria
| Inclusion criteria | Rationale | Source |
|---|---|---|
| Age 21 y -65 y inclusive | Individuals > 65 are not as likely to tolerate the biomechanical tests and experience altered sensorimotor function. Children not considered for study | PS, BL1 Int |
| Acute, sub-acute or chronic LBP matching QTF classifications 1, 2, 3 or 7 | Low back pain, uncomplicated by known nerve compression, neurological signs or prior surgery | Exam, CR |
| Numerical Pain Rating Scale of > 4 at PS or BL1 &≥2 at PS, BL1, BL2 | Low back pain with enough severity to demonstrate clinical improvement | PS, HA1, HA2 |
| Signed the Informed Consent Documents | Research policy | PS, BL1 Int, BL2 Int |
| Exclusion criteria | Rationale | Source |
| Bleeding disorders | Safety concern for biomechanical testing procedures | Exam, CR |
| Sensitivity to tape used during the sensorimotor function tests | Safety concern for biomechanical testing procedures | BL1 Int, Exam |
| Pregnancy or nursing | Safety concern for biomechanical testing procedures | PS, BL1 Int, BL2 Int |
| Contra-indication to SM | Safety concern for treatment protocols | Exam, CR |
| Joint Replacement | Safety not confirmed for biomechanical testing | PS, BL1 Int, Exam, BL2 Int |
| Pacemaker | Safety not confirmed when used near biomechanical equipment producing electromagnetic field | PS, BL1 Int, Exam, BL2 Int |
| Extreme obesity (≥ 307 lbs) | Safety concern related to equipment weight capacity | BL1 Int |
| Vascular claudication | Condition can result in intolerance to biomechanical testing protocols | PS, Exam, CR |
| Bone and joint abnormality | Condition can result in intolerance to biomechanical testing or treatment protocols | PS, Exam, CR |
| Inflammatory or Destructive tissue changes to the spine | Condition can result in intolerance to biomechanical testing or treatment protocols | Exam, CR |
| Osteoporosis | Condition can result in intolerance to biomechanical testing or treatment protocols | PS, Exam, CR |
| General poor health | Overall condition is too poor to tolerate both treatment and biomechanical testing procedures | Exam, CR |
| Neuromuscular Diseases | Condition might interfere with data collection | PS, Exam, CR |
| Peripheral Neuropathies | Condition might interfere with data collection | PS, Exam, CR |
| Spinal Surgery | Condition might interfere with data collection | PS, Exam, CR |
| Suspicion of drug or alcohol abuse | Condition can interfere with ability to comply with study protocol and data collection | BL1 Int, Exam, CR |
| Uncontrolled hypertension | Condition might make it difficult to receive treatment or perform research procedures | PS, BL1 Int, Exam |
| BDI-II ≥ 29 | Condition can interfere with ability to comply with study protocol and data collection | HA1 |
| QTF 4-6 & 8-11 | Condition of sufficient complicated nature to cause intolerance to biomechanical testing procedures or data collection | Exam, CR |
| Cauda Equina Syndrome | Requires emergency surgical evaluation | Exam, CR |
| Inability to read or verbally comprehend English | Difficult to ensure full consent | PS, BL1 Int |
| Further diagnostic procedures other than dipstick urinalysis or x-rays | Advanced diagnostic testing was unavailable | Exam, CR |
| Retention of legal advice and open or pending case related to LBP | May interfere with study compliance | PS, BL1 Int, BL2 Int |
| Ongoing treatment for LBP by other health care providers | Possible confounding data | PS, BL1 Int, BL2 Int |
BDI-II- Beck Depression Inventory; BL1- Baseline Visit 1; BL2- Baseline Visit 2; CR- Case Review; Exam- Determined by the examining clinician; HA1- Health Assessment Questionnaire administered at BL1; HA2- Health Assessment Questionnaire administered at BL2; Int- Study Coordinator administered Interview; PS- Phone CATI Screen; QTF- Quebec Task Force; SM- Spinal Manipulation