The Back Pain and Movement (B-PAM) registry; a study protocol.

BACKGROUND

Low back pain (LBP) is a ubiquitous, heterogeneous disorder that affects most people at some point in their lives. The efficient management of LBP remains elusive, with direct and indirect costs attributed to LBP surpassing many other common conditions. An emphasis on a structural basis of LBP often fails to recognize movement, specifically patterns of movement that may provide biomechanical signatures of painful conditions. The primary objective of this registry is to understand the differences in movement patterns among those with LBP and those without pain in a U.S. population sample.

METHODS

This ongoing, non-randomized, prospective post-market registry will consist of two groups: patients with LBP, and age and sex-matched controls without LBP. We will seek to recruit 132 subjects in each group. Data collection will take place in two phases: (1) baseline assessment of LBP patients and matched controls; (2) assessment of LBP patients at 6 and 12-months follow up. The primary outcome measure will be differences in movement patterns between those with LBP and those without LBP. Secondary outcomes will include differences in patient reported outcomes including pain, disability and quality of life.

DISCUSSION: The findings will help determine if there are meaningful differences in movement patterns between those with and those without LBP. Further, an initial understanding of movement signatures specific to certain subtypes of patients with LBP may be achieved.

TRIAL REGISTRATION: The study was registered on the clinicaltrials.gov portal: NCT03001037 . Trial retrospectively registered 12/22/2016.