Objective The purpose of this study is to measure the prevalence of graded disc degeneration, spondylolisthesis, transitional segmentation and the distribution of sacral slope in patients 21 to 65 years of age with chronic low back pain (CLBP). Methods This retrospective study analyzed 247 digital lumbar radiographic series obtained during a randomized controlled trial of chiropractic patients with CLBP. CLBP was defined as pain in the low back lasting 12 weeks or longer. Radiographic findings of disc degeneration, spondylolisthesis, and lumbosacral transitional segmentation were graded by 2 authors using established classification criteria. Sacral slope was measured with a digital tool contained within imaging software. Results Lumbosacral transitional segments graded I – IV (Castellvi classification) were present in 14% of cases. Lumbar disc degeneration was most prevalent at L3-4 (49%) followed by L4-5 (42%), L2-3 (41%), L5-S1 (37%), and L1-2 (29%). Isthmic spondylolisthesis was present in 5% of cases with L5 the most common location. Degenerative spondylolisthesis demonstrated a prevalence rate of 18%, most commonly occurring at L4. The prevalence of degenerative spondylolisthesis was 51% for females aged 50–59 and 24% for males in the same age range. Conclusions Moderate-severe disc degeneration, multi-level disc narrowing, and degenerative spondylolisthesis were common in individuals with CLBP over age 40. Isthmic spondylolisthesis was not more prevalent than what has been reported in other populations. Transitional segmentation was identified in a minority of participants with some of these exhibiting accessory joints or fusion. Mean sacral slope in individuals with CLBP was not substantially different from mean slopes reported in other populations.

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PurposeTo describe a consensus-based case review development process that applies eligibility and diagnostic criteria for diverse clinical trials of chiropractic care for chronic pain conditions. MethodsA multidisciplinary team of investigators and clinical research staff provide iterative feedback to develop case review processes for application across complex clinical trials involving biomechanical testing and/or spinal manipulation. Investigative team members design eligibility criteria and operational definitions consistent with the specific aims of the trial. These parameters are codified in study protocols and programmed into secure, web-based data collection systems that record eligibility decisions. The clinical team develops study-specific procedures, documentation templates, and flow-charts for conducting meetings. Research records are uploaded onto a web server for panel members to view during the meeting. ResultsOur case review panel consists of research clinicians, project managers, study coordinators and the senior clinician who convene twice weekly to discuss participants who remain eligible following completion of baseline visits. The research clinician who performed the eligibility examination begins case review with an oral presentation of the case and leads the case review panel through a discussion of safety and compliance issues, eligibility concerns, diagnosis determination, and clinical precautions. Panel members provide clinical recommendations and determine final eligibility status by consensus vote. The senior clinician determines eligibility only in cases where consensus (80%) is not reached. Through this process, our research clinic presented 534 cases, excluded 174 participants, and allocated 291 into two phase II clinical trials and six feasibility studies over a three year period. ConclusionOur case review process utilizes the combined scientific and clinical experience of panel members for consistent eligibility determination, thereby reducing selection bias and ensuring that participants are appropriate candidates for study procedures. The consensus building process creates a collegial environment that enhances clinical trial management and fosters rigorous clinical research.