The proposed pilot application is designed to prepare for a three-site randomized controlled clinical efficacy trial that compares, in older veterans with low back pain (LBP) outcomes associated with patient-centered comprehensive evaluation and treatment (PCCET) versus imaging-associated usual care (IAUC). Veterans who have just had lumbar Magnetic Resonance Imaging (MRI) will be targeted, as these patients often have not had a comprehensive history and physical examination to identify all contributors to their pain and disability and, therefore, are at high risk of experiencing suboptimal outcomes. Much of MRI-identified degenerative lumbar pathology is incidental in older adults and its identification often leads to invasive procedures that are ineffective and potentially dangerous. The pilot study has four aims.
Aim 1 : Evaluate the feasibility of the recruitment strategy for the future clinical effiacy trial by reviewing electronic medical records for inclusion and exclusion criteria (no red flags tht would require urgent LBP treatment, no previous spine surgery, no dementia). Records of veterans age 65-89 who are scheduled for a lumbar MRI will be reviewed at each of the three sites for one year. An estimated 314 participants will be needed for the future clinical efficacy trial (alpha .025, power 90%, effect 0.4) to detect meaningful between group differences in two primary outcome measures, the Roland Disability Questionnaire (RDQ) and the Short Physical Performance Battery (SPPB).
Aim 2 : Assess inter-rater agreement of the structured assessment that will be used to guide LBP care in the PCCET arm of the future clinical efficacy trial. The principal investigator has previously developed and published a LBP assessment protocol. She will teach two-three geriatrician providers at each of the three sites (Pittsburgh, Miami, Richmond) in performance of the protocol and 45 older veterans (15 at each site) will be evaluated using this tool. Veterans also will be evaluated for other key pain and disability generators - depression (with the CES-D), anxiety (with the GAD-7), mild cognitive impairment (with the computer-based assessment of mild cognitive impairment), fear avoidance beliefs (with the Fear Avoidance Beliefs Questionnaire), and pain coping skills (with the Cognitive Strategies Questionnaire). The PI and geriatrician providers will use these data combined with supplemental clinical interviews as indicated, to identify the contributors to LBP and disability from a structured checklist and inter-rater agreement will be evaluated. We will train providers to an inter-rater agreement of > .95.
Aim 3 : Estimate sample size for the future clinical efficacy tril by assessing the anticipated change in primary outcomes during IAUC and PCCET. For IAUC, another group of 45 veterans (15 at each site) will be invited to participate via primary care provider-signed letters. Volunteers will be evaluated on-site to confirm eligibility and collect th primary outcome measures for the clinical trial - the RDQ and the SPPB. Participants will be telephoned monthly to collect structured information on LBP interventions sought and received. For PCCET, 20 veterans treated in the PI's pain clinic will be followed in a manner similar to the IAUC participants. The RDQ and SPPB will be repeated in 6 months on all and 12 months on 75% of participants.
Aim 4 : Standardize the treatments that will be delivered in the PCCET arm of the future clinical efficacy trial. This will be accomplished by drawing from evidence-based literature and a 33-member interdisciplinary panel of experts (geriatric medicine, geriatric pharmacology, geriatric psychiatry, low back pain, pain medicine, primary care, psychology, rehabilitation medicine and rheumatology) using a Modified Delphi technique. After accomplishing the aims outlined, we will be well- prepared to design the clinical efficacy trial tht has the potential to improve function and quality of life for millions of older veterans.
Currently there are over 9 million United States veterans age 65 and older and low back pain (LBP) is one of the most common causes of disability in these individuals.1,17 When these patients are evaluated using advanced imaging (e.g., MRI) and treated as an aging spine rather than an older adult with spine pain, results are often suboptimal. Spinal arthritis is common in older adults with and without pain and conditions outside of the spine such as hip arthritis, depression, and fibromyalgia may be responsible for LBP and disability, but practitioners are often poorly educated about these conditions.4,5,48,49 Thus we are ill-equipped to implement the 1998 VHA National Pain Management Strategy for older veterans with LBP. This pilot study will inform a future randomized controlled trial to evaluate the benefits in veterans with LBP age 65-89 who have undergone lower back MRI of patient-centered comprehensive treatment as compared with usual care. We believe the patient-centered comprehensive approach could save substantial suffering for millions of older veterans.
