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 |