Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)

NCT ID: NCT02697435

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2018-08-31

Brief Summary

Back pain is a huge problem for millions of Americans, including nearly 11 million Veterans. Our older Veterans suffer the most. Citizens spend billions of dollars, yet consistently get poor results. Primary Care Providers are often tasked with diagnosing and treating Chronic Low Back Pain, even though they are often undereducated in the field. These PCPs often use advanced imaging, usually MRIs to guide care. These images often show degenerative disc disease and other common pathologies in older adults, even those who are pain free, which can lead to misdiagnosis and treatment. The investigators believe that Chronic Low Back Pain is a syndrome, a final common pathway for the expression of multiple contributors that often lie outside the spine itself. For example, hip osteoarthritis, knee pain, and even anxiety could all lessen back pain if addressed and treated probably.

Investigators will measure participants' low back pain-associated disability with the well-validated RMDQ. Data will be collected at baseline and monthly via telephone. The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain-associated disability than those who receive IAUC at six months.

Investigators will also measure participants' low back pain with the 0-10 Numeric Rating Scale for Pain. Data will be collected at baseline and monthly via telephone. The investigators hypothesize that veterans who receive PCCET will experience significantly greater reduction in low back pain than those who receive IAUC at six months.

The goal of this study is to compare patients treated with usual care, which usually starts with imaging, versus patients who are treated by trained geriatricians who know how to recognize and address 11 key conditions that commonly drive pain and disability in older adults. The investigators believe that older patients who receive care tailored to their needs by educated PCPs will ultimately have less back pain and, more importantly, better quality of life.

Detailed Description

Nearly half of our 22 million US military Veterans are age 65 and older and, within this population, low back pain is common, costly and often disabling. The prevalence of low back pain in those 85+, the most vulnerable and fastest growing segment of society, is estimated at 44%. Chronic low back pain (CLBP, i.e., present for 6 months or more) is associated with the overwhelming majority of healthcare resource utilization and personal suffering. Treating back problems cost Americans more than $30 billion in 2007- up from $16 billion in 1997 (in 2007 dollars). Despite these staggering data, there is no evidence that the care of patients with CLBP has improved, and the use of invasive, potentially morbid, and often ineffective interventions (e.g., epidural corticosteroid injections and spine surgery) continues to skyrocket. Primary care providers (PCP) who are tasked with treating CLBP without adequate education often use advanced imaging (most commonly magnetic resonance imaging [MRI]) to guide care. Imaging-identified pathology (e.g., degenerative disc and facet disease, bulging discs) is ubiquitous in older adults, even in those that are pain-free. It is not surprising, therefore, that imaging-guided treatments often lead to suboptimal outcomes and potential morbidity. In contrast to how CLBP is often conceptualized and treated, the investigators conceptualize CLBP as a syndrome, that is, a final common pathway for the expression of multiple contributors that often lie outside the spine itself, for example, hip osteoarthritis, fibromyalgia syndrome, and anxiety. Treating CLBP and ameliorating disability in older adults necessitates addressing multiple conditions and risk factors; however, the expertise to evaluate and treat all of the disorders that can contribute to CLBP typically resides in multiple specialty silos, making a comprehensive approach to treating CLBP difficult to implement.

Through the support of a 2-year Rehab R&D Merit Review pilot award, the investigators have laid the essential foundation for delivering more comprehensive and patient-centric care to older Veterans with CLBP. The investigators have:

• 1) synthesized, through a modified Delphi process, evidence on evaluating and treating 11 key conditions that commonly drive pain and disability in older adults with CLBP
• 2) created algorithms to be used in the clinical setting to treat these 11 conditions
• 3) successfully trained geriatrician providers in a practical structured assessment of the 11 conditions, and
• 4) validated the prevalence of these conditions specifically in older Veterans

In the current application, the investigators are proposing a 2-site pilot study to explore the impact of delivering patient-centered comprehensive evaluation and treatment (PCCET) as compared with imaging-associated usual care (IAUC) to older Veterans with CLBP. In addition to examining whether PCCET is more effective than IAUC for reducing pain and functional limitations when delivered by geriatricians in 2 VA medical centers, the investigators will evaluate PCCET's impact on health-related quality of life and health care utilization. The investigators also will collect data to identify barriers and facilitators to implementing PCCET from the perspective of patients and providers.

Conditions

Chronic Low Back Pain; Hip Ostearthritis; Myofascial Pain Syndrome; Fibromyalgia; Depression; Maladaptive Coping; Lumbar Spinal Stenosis; Insomnia; Sacroiliac Joint Pain; Lateral Hip and Thigh Pain; Anxiety; Dementia; Recent Leg Length Discrepancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Patient-Centered Care

Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain.

Group Type: EXPERIMENTAL

Patient-Centered Care

Intervention Type: OTHER

Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs.

Imaging-Directed Care

Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.

Group Type: PLACEBO_COMPARATOR

Imaging-Directed Care

Intervention Type: OTHER

Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.

Interventions

Patient-Centered Care

Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs.

Intervention Type: OTHER

Imaging-Directed Care

Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• English-speaking (to ensure the validity of data collected)
• Age 60 and older
• Lumbar MRI within past 30 days and is without evidence of infection, malignancy, or acute fracture OR scheduled for a lumbar MRI within the next 30 days
• CLBP, defined as pain in the lower back of at least moderate severity (assessed with a verbal rating scale), every day or almost every day, for at least 3 months
• No red flags that would indicate a serious underlying disorder that would necessitate urgent and specialized treatment, i.e.,

• weight loss
• fever
• sudden severe LBP
• change in bowels/bladder
• back pain that awakens from sleep
• recent leg weakness
• No pain in other body locations that is more severe than their low back pain
• No psychotic symptoms
• No previous spine surgery
• No dementia (Folstein Mini-Mental State Examination score of > 24)
• No acute illness
• No prohibitive communication impairment (e.g., severe hearing or visual impairment)
• Able to commit to 6 months of study participation

Exclusion Criteria

• Vulnerable subjects will not be enrolled
• Neither pregnant subjects nor women of childbearing potential will be included because the investigators are targeting older Veterans with CLBP
• Neither children nor prisoners will be included
• Incompetent subjects will be excluded from participating in this research, as determined by performance on the Folstein Mini Mental State Examination

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra K. Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO 1653

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F2021-P

Identifier Type: -

Identifier Source: org_study_id