Aging Back Clinics

NCT ID: NCT03564600

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-03
• Study Completion Date: 2024-03-29

Brief Summary

The purpose of this study is to compare two different ways to treat chronic low back pain. The two types of treatment that the investigators will compare are called Usual Care and ABC Care. Usual Care tends to focus on the spine. ABC Care focuses on the entire body and the mind. With Usual Care, participants will work with their own doctor to come up with a treatment plan. With ABC Care, participants will work with the investigators' ABC providers and their team. The investigators believe ABC Care will help reduce pain, lower costs, and increase participants' ability to do the things they enjoy doing better than Usual Care. In ABC Care the investigators hope to avoid treatments like surgeries where participants get metal rods put in their back.

This research is being done at three Veterans Hospitals: the Veterans Administration of Pittsburgh Healthcare System (VAPHS) in Pittsburgh, PA; the North Texas VA Medical Center in Dallas, TX; and the Hunter Holmes McGuire VA Medical Center in Richmond, VA. This research study is being paid for by the Rehabilitation Research and Development section of the Veterans Health Administration.

The investigators will be enrolling about 450 participants at 3 sites or around 150 at each site.

Detailed Description

Degenerative disease of the lumbar spine is ubiquitous in older adults, but low back pain is not. Treatments that focus exclusively on degenerative spine disease, such as spinal injection and surgery, have resulted in rising costs and exposure to potentially life-threatening morbidity but outcomes have not improved. The investigators posit that to improve treatment outcomes for older adults with chronic low back pain (CLBP - back pain that has been present on at least half the days for at least 6 months), the condition should be approached as a syndrome, that is, a final common pathway for the expression of many contributors, in the same way that geriatricians approach the evaluation and treatment of delirium and falls. Using this model, the lumbar spine is considered a weak link, but is rarely the sole treatment target. Conditions that commonly contribute to pain and disability in older adults with CLBP include hip osteoarthritis, fibromyalgia, anxiety, maladaptive coping, and myofascial pain, each of which is associated with specific evidence-based treatments. Because such conditions are not routinely evaluated in patients with CLBP, it is perhaps not surprising that first line treatments that do not specifically target multiple contributors (e.g. spine-focused physical therapy and analgesics) often provide suboptimal treatment outcomes. This often results in continued treatment-seeking including potentially toxic medications and invasive, expensive, and potentially life-threatening procedures such as complex spinal fusion.

The central question that the proposed randomized trial is designed to answer is: What is the efficacy of caring for older adults with CLBP in Aging Back Clinics (ABC), where the patient is first treated as an older adult, and second as a patient with CLBP, compared with usual care (UC)? The investigators have developed evidence and expert-opinion based guidelines for the evaluation and treatment of 12 key contributors to pain and disability in older adults with CLBP. The investigators' prior work also supports the commonplace nature of multiple contributors to CLBP in older Veterans and the feasibility of delivering patient-centered comprehensive care that follows the investigators' published guidelines. The investigators now wish to implement these guidelines in the investigators' ABC clinics and compare this approach to that of UC in older Veterans. Proof of the hypotheses could significantly impact patient care by reducing pain and disability and identifying key conditions whose treatment could prevent the pursuit of invasive treatments and their associated potential morbidity and cost.

About 450 Veterans age 65-89 with CLBP will be recruited from primary care provider practices at 3 VAs - VA Pittsburgh Healthcare System, Dallas VA, and Richmond VA to meet a target randomization of 330. Individuals will be randomized to receive either ABC care or UC and they will be followed for one year. Those in ABC care will be referred to a generalist (e.g., geriatrician, physiatrist, rheumatologist) that has been identified and trained in a structured assessment to identify the conditions for which evidence and expert opinion-based algorithms have been created. Usual care will not be constrained. Outcomes will be assessed at baseline and over the telephone at three later time points: 6 months, 9 months and 12 months. Health Care Utilization will be assessed monthly. Gait speed, a strong predictor of morbidity and mortality in older adults, will be measured at baseline. The proposed clinical trial has the potential not only to improve pain-related disability, but also to reduce morbidity, increase quality of life, and limit healthcare utilization.

Conditions

Chronic Low Back Pain

Study Design

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

Study Groups

ABC Group

Veterans with back pain for at least the past 6 months receive personalized care by providers trained based on a published set of algorithms that guide care for conditions that contribute to disability in older adults with chronic low back pain

Group Type: EXPERIMENTAL

Aging Back Clinics management

Intervention Type: OTHER

Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.

UC Group

Veterans with back pain for at least the past 6 months who receive usual care as directed by their primary care physician.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aging Back Clinics management

Personalized care is delivered that is guided by published algorithms for each component condition identified by a trained provider.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Older Veterans with CLBP, defined as pain in the lower back of at least moderate severity.

• assessed with a verbal rating scale on > half the days for > 6 months
• Veterans must be English speaking.
• Must be able to commit to 12 months of study participation.
• The Quick Mild Cognitive Impairment Screen (QMCI) will be administered on site to screen for mild cognitive impairment (MCI).

• Those with MCI will not be excluded, but their PCP will be alerted.

Exclusion Criteria

• Positive screen for dementia (score <23 on the MMSE)
• Pain in other body locations that is more severe than their low back pain
• Red flags indicative of serious underlying illness requiring urgent care

• e.g., fever, change in bowel/bladder function, sudden severe change in pain, unintentional weight loss, new lower extremity weakness
• Previous lumbar surgery.
• Acute illness.
• Psychotic symptoms.
• Prohibitive communication impairment.

• e.g., severe hearing or visual impairment.
• Neither pregnant subjects nor women of childbearing potential will be included due to the age requirements of the study.
• Vulnerable subjects will not be enrolled, nor children and prisoners.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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 Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

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

O2808-R

Identifier Type: -

Identifier Source: org_study_id