Aging Back Clinics

NCT03564600 | Completed Results

• 1 other identifier: O2808-R
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Low Back Pain

Keywords

low back pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI) Change

  The ODI assesses interference of pain with function. This questionnaire is used by clinicians and researchers to quantify disability for low back pain. Range 0 to 100 with higher score indicating greater disability.

  Baseline visit, every three months for up to one year

Study Arms (2)

ABC Group

EXPERIMENTAL

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

Other: Aging Back Clinics management

UC Group

NO INTERVENTION

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

Interventions

Aging Back Clinics management OTHER

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

ABC Group

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Debra K. Weiner, M.D.
• Organization: University of Pittsburgh School of Medicine

dweiner@pitt.edu

4124016811

Study Officials

• Debra K. Weiner, MD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 21, 2018
• Study Start: January 3, 2019
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)