| PMC full text: | Published online 2016 Feb 9. 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 |