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. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161

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