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

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02697435
• Collaborator: (none)
• Enrollment: 55
• Locations: 2
• Arms: 2
• Actual Duration (Months): 29
• Patients Per Site: 27.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Patient-Centered Care; Other: Imaging-Directed Care	N/A

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
• 1. created algorithms to be used in the clinical setting to treat these 11 conditions
• 1. successfully trained geriatrician providers in a practical structured assessment of the 11 conditions, and
• 1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Primary Purpose: Treatment
• Official Title: Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Placebo Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ) [Baseline and 6 months]

   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.

2. Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale [Baseline and 6 months]

   Pain rated on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain. Outcome is change score.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240
2	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia	United States	23249

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Debra K. Weiner, MD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 11, 2019

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02697435
• Other Study ID Numbers: F2021-P; PRO 1653
• First Posted: Mar 3, 2016
• Last Update Posted: Aug 19, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: 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
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Spinal Stenosis; Arthralgia; Leg Length Inequality; Dementia; Back Pain; Low Back Pain; Constriction, Pathologic; Depression

Study Results

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 Detail	There was no wash out or run in period.

Arm/Group Title	Patient-Centered Care	Imaging-Directed Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	25	30
COMPLETED	24	26
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Patient-Centered Care	Imaging-Directed Care	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	25	30	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 16%	12 40%	16 29.1%
>=65 years	21 84%	18 60%	39 70.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (7.5)	67.2 (5.5)	69.1 (6.7)
Sex: Female, Male (Count of Participants)
Female	1 4%	1 3.3%	2 3.6%
Male	24 96%	29 96.7%	53 96.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 32%	9 30%	17 30.9%
White	17 68%	20 66.7%	37 67.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 3.3%	1 1.8%

Outcome Measures

1. Primary Outcome

Title	Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Patient-Centered Care	Imaging-Directed Care
Arm/Group Description	Patient-Centered Care (i.e., ABC 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 in older adults. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs.	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.
Measure Participants	24	26
Mean (Standard Deviation) [score on a scale]	-1.29 (6.05)	-0.08 (4.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient-Centered Care, Imaging-Directed Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	P-value is calculated.
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patient-Centered Care	Imaging-Directed Care
Arm/Group Description	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.	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.
Measure Participants	24	26
Mean (Standard Deviation) [units on a scale]	0.46 (2.99)	0.96 (2.18)

Adverse Events

Time Frame	through the duration of the study, up to 2 years.
Arm/Group Title	Patient-Centered Care		Imaging-Directed Care
Arm/Group Description	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.		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.
All Cause Mortality
	Patient-Centered Care		Imaging-Directed Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/30 (0%)
Serious Adverse Events
	Patient-Centered Care		Imaging-Directed Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Patient-Centered Care		Imaging-Directed Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.