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

Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02697435
Enrollment
55
Registered
2016-03-03
Start date
2016-04-01
Completion date
2018-08-31
Last updated
2019-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Pain, Aged, Elderly, Primary Care, Assessment, Lumbar, Spinal Stenosis, Hip Osteoarthritis, 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

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.

Interventions

OTHERPatient-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.

OTHERImaging-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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)Baseline and 6 monthsThe 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.
Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating ScaleBaseline and 6 monthsPain rated on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain. Outcome is change score.

Countries

United States

Participant flow

Recruitment details

Using an IRB-approved waiver of consent, research coordinators (RCs) screened CPRS records of Veterans age 60-89 with low back pain.Those eligible were mailed a study brochure and a letter signed by the chief of Primary Care. Additional screening was performed on those who called the RC. Those eligible were further screened on site.

Pre-assignment details

There was no wash out or run in period.

Participants by arm

ArmCount
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. 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.
25
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. 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.
30
Total55

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision04
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicPatient-Centered CareImaging-Directed CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
21 Participants18 Participants39 Participants
Age, Categorical
Between 18 and 65 years
4 Participants12 Participants16 Participants
Age, Continuous71.3 years
STANDARD_DEVIATION 7.5
67.2 years
STANDARD_DEVIATION 5.5
69.1 years
STANDARD_DEVIATION 6.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants9 Participants17 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
17 Participants20 Participants37 Participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
24 Participants29 Participants53 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 30
other
Total, other adverse events
0 / 250 / 30
serious
Total, serious adverse events
0 / 250 / 30

Outcome results

Primary

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.

Time frame: Baseline and 6 months

ArmMeasureValue (MEAN)Dispersion
Patient-Centered CareParticipants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale0.46 units on a scaleStandard Deviation 2.99
Imaging-Directed CareParticipants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale0.96 units on a scaleStandard Deviation 2.18
Primary

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.

Time frame: Baseline and 6 months

Population: All participants were called monthly for 6 months. One main outcome measure was Roland Morris score at 6 months.

ArmMeasureValue (MEAN)Dispersion
Patient-Centered CareParticipants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)-1.29 score on a scaleStandard Deviation 6.05
Imaging-Directed CareParticipants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)-0.08 score on a scaleStandard Deviation 4.12
p-value: <0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026