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. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8

Table 1.

Eligibility criteria

Inclusion criteria Rationale
Age ≥ 18 and ≤ 50 Age range of most active duty U.S. military personnel
Acute, subacute, or chronic low back pain Low back pain commonly treated by primary care and chiropractic providers
Ability to provide voluntary written informed consent Able to comprehend study details; able to make decisions without limitations or impairment
Active duty status at one of the three participating military treatment facilities Chiropractic care available only to active duty personnel at U.S. military treatment facilities
Exclusion criteria
LBP from a non-musculoskeletal source (pain from a visceral condition[s]) Care outside study scope needed; potential to confound health outcomes
Co-morbid pathology that may directly impact spinal pain Care outside study scope needed; potential to confound health outcomes
Recent spinal fracture (within the last 8 weeks) May influence ability to measure pain-related health outcomes; safety concern
Recent spinal surgery (within the last 12 weeks) Potential to confound health outcomes due to natural history or from potential complications
Spinal or paraspinal tumor(s) Care outside study scope needed
Spinal or paraspinal infection(s) Care outside study scope needed
Spinal inflammatory arthropathy (rheumatoid arthritis, enteropathic spondyloarthropathy) Potential to confound health outcomes
Contraindication(s) for spinal manipulation of the lumbar spine and pelvis (unstable spinal segments, cauda equina syndrome) Care outside study scope needed
Pregnancy or plans to become pregnant within active treatment period Potential to confound health outcomes
Diminished/altered mental capacity May prohibit informed consent or compromise safety or compliance with study procedures
Use of spinal manipulative care for any reason within the past month Prevent carryover effects from recent chiropractic care
Significant/severe osteoporosis Potential to confound health outcomes; care outside study scope may be needed
Unwilling to provide phone and electronic contact information Compromises ability to adhere to study protocol
Unable to confirm availability during the active treatment period due to known deployment, orders for a distant duty assignment, or other absence Compromises ability to adhere to study protocol
Does not agree to be enrolled regardless of group assignment Compromises ability to adhere to study protocol
Post-traumatic stress disorder diagnosis Potential to confound health outcomes