Chronic Low Back PainNCT02697435
Making Better Lives: Patient-Focused Care for Low Back Pain (LBP)
A study testing Patient-Centered Care and Imaging-Directed Care in people with Chronic Low Back Pain and Hip Ostearthritis, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Chronic Low Back Pain, Hip Ostearthritis, Myofascial Pain Syndrome
- What is being tested?
- Patient-Centered Care and Imaging-Directed Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2016to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249
About this study
Official title: Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Low Back Pain, Hip Ostearthritis, Myofascial Pain Syndrome, Fibromyalgia, Depression, Maladaptive Coping
- Being tested
- Patient-Centered Care, Imaging-Directed Care
- 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
- Medical subject headings
- Myofascial Pain Syndromes, Fibromyalgia, Depression, Spinal Stenosis, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Dementia, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Imaging-Directed Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start1 Apr 2016
- Primary completion31 May 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Debra K. Weiner, MD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697435
- Sponsor's protocol ID
- F2021-P
- Other IDs
- PRO 1653
- Status last verified
- Jul 2019
- First submitted
- 12 Feb 2016
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Versus Imaging-Directed Care for Older Veterans With Chronic LBP
- ClinicalTrials.gov ID
- NCT02697435
- Acronym / sponsor ID
- F2021-P
- Conditions
- Chronic Low Back Pain, Hip Ostearthritis, Myofascial Pain Syndrome, Fibromyalgia, Depression, Maladaptive Coping
- Keywords
- Chronic Low Back Pain, Aged, Elderly, Primary Care, Assessment, Lumbar, Spinal Stenosis, Hip Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-Centered Care | Experimental | Other: Patient-Centered CarePatient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. |
| Imaging-Directed Care | Placebo comparator | Other: Imaging-Directed CareImaging-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. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Centered CarePatient-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. | Other | Patient-Centered Care |
| Imaging-Directed CareImaging-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 |
Primary outcome
Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)
Time frame: 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.
Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra K. Weiner, MD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Care and Imaging-Directed Care in people with Chronic Low Back Pain and Hip Ostearthritis, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.