Trials Sponsors Conditions Drugs Pricing

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.

Conditions

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

Keywords

Chronic Low Back PainAgedElderlyPrimary CareAssessmentLumbarSpinal StenosisHip OsteoarthritisMyofascial Pain SyndromeFibromyalgiaDepressionMaladaptive CopingLumbar Spinal StenosisInsomniaSacroiliac Joint PainLateral Hip and Thigh PainAnxietyDementiaRecent Leg Length Discrepancy

Outcome Measures

Primary Outcomes (2)

Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)
The Roland Morris Questionnaire is a 24 item yes/no measure of back pain interference with various daily activities. It is a well validated measure of low back pain disability. The total score ranges from 0 to 24 with a higher score meaning greater impairment. Our main outcome measure is reported as the change in Roland Morris score from baseline to 6 months.
Baseline and 6 months
Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale
Pain rated on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain. Outcome is change score.
Baseline and 6 months

Study Arms (2)

Patient-Centered Care

EXPERIMENTAL

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.

Other: Patient-Centered Care

Imaging-Directed Care

PLACEBO COMPARATOR

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.

Other: Imaging-Directed Care

Interventions

Patient-Centered CareOther

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.

Patient-Centered Care

Imaging-Directed CareOther

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.

Eligibility Criteria

Age60 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

English-speaking (to ensure the validity of data collected)
Age 60 and older

Sponsors & Collaborators

VA Office of Research and Development
US federal agencylead

Study Sites (2)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

MeSH Terms

Conditions

Myofascial Pain SyndromesFibromyalgiaDepressionSpinal StenosisSleep Initiation and Maintenance DisordersAnxiety DisordersDementiaOsteoarthritis, Hip

Interventions

Patient-Centered Care

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Results Point of Contact

Title: Debra Kaye Weiner, M.D.
Organization: VAPHS

Study Officials

Debra K. Weiner, MD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

55 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Masking Details: Research Coordinators who perform the "data measure" portion of the baseline are masked from knowing which group (usual care or patient care) the participant ends up in. This is also true of monthly follow-up calls.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: FED
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

March 3, 2016

Study Start

April 1, 2016

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Patient-Centered Care

Imaging-Directed Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Patient-Centered Care

Imaging-Directed Care

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Documents

Locations