Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

Abstract

BackgroundLow back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults.Methods/designThis pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes.DiscussionThis pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.Trial registrationThis trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233.

BAck complaints in the elders - chiropractic (BACE-C): protocol of an international cohort study of older adults with low back pain seeking chiropractic care

“…Patient-related factors: The following factors will be measured at baseline: 1) sociodemographic characteristics (i.e. age, gender, marital status, education level, height, weight); 2) physical activity (measured with the International Physical Activity questionnaire [15]); 3) other lifestyle variables smoking; measured by pack years, alcohol use measured by the short version of the AUDIT-C [17,18], sleeping habits; measured by the short version of the Pittsburgh Sleep Quality Index [19]; 4) comorbidities using the Selfadministered Comorbidity Questionnaire [20] and 7)…”

“…Chiropractors provide a significant portion of care for patients with low back pain [10], and care from chiropractors in the younger and older population appears to be safe and effective [11][12][13]. Unfortunately, existing trials have typically included only younger adults with low back pain, and exclude older adults for various complicating reasons, such as comorbidity and polypharmacy [14,15]. As a significant proportion of chiropractors treat older adults [11], it is important to understand the course and characteristics of low back pain in older adults under this care.…”

A graphical clinical decision aid for managing imaging report information

“…Reports were obtained from records generated from a previous randomized controlled trial during which participants aged 65 years or older with subacute or chronic low back pain underwent digital X-ray imaging. 18 All participants were ambulatory. A complete list of inclusion/exclusion criteria can be found in the published study protocol.…”

“…A complete list of inclusion/exclusion criteria can be found in the published study protocol. 18 This secondary analysis was deemed exempt by the institutional review board Human Protections Office of Palmer College of Chiropractic. Radiology reports were generated by board-certified medical or chiropractic radiologists from either a regional health care facility or the radiology department within the Palmer College of Chiropractic clinic system.…”

BAck Complaints in the Elders - Chiropractic (BACE-C): Design of a cohort study in chiropractic care

“…Chiropractors provide a significant portion of care for patients with low back pain (10), and care from chiropractors in the younger and older population appears to be safe and effective (16)(17)(18). Unfortunately, existing trials have typically included only younger adults with low back pain, and exclude older adults for various complicating reasons, such as comorbidity and polypharmacy (19)(20)(21). As a significant proportion of chiropractors treat older adults (16), it is important to understand the course and characteristics of low back pain in older adults under this care.…”