Pain Medicine 2020 (Dec 12); 21 (Suppl 2): S37–S44
Cynthia R. Long, PhD, Anthony J. Lisi, DC, Robert D. Vining, DC, DHSc, Robert B. Wallace, MD, MSc, Stacie A. Salsbury, PhD, RN, Zacariah K. Shannon, DC, MS, Stephanie Halloran, DC, MS, Amy L. Minkalis, DC, MS, Lance Corber, MSITM, Paul G. Shekelle, MD, PhD Erin E. Krebs, MD, MPH, Thad E. Abrams, MD, MS, Jon D. Lurie, MD, MS, and Christine M. Goertz, DC, PhD
Palmer Center for Chiropractic Research,
Palmer College of Chiropractic,
Davenport, IA, USA.
Background: Low back pain is a leading cause of disability in veterans. Chiropractic care is a well-integrated, nonpharmacological therapy in Veterans Affairs health care facilities, where doctors of chiropractic provide therapeutic interventions focused on the management of low back pain and other musculoskeletal conditions. However, important knowledge gaps remain regarding the effectiveness of chiropractic care in terms of the number and frequency of treatment visits needed for optimal outcomes in veterans with low back pain.
Design: This pragmatic, parallel-group randomized trial at four Veterans Affairs sites will include 766 veterans with chronic low back pain who are randomly allocated to a course of low-dose (one to five visits) or higher-dose (eight to 12 visits) chiropractic care for 10 weeks (Phase 1). After Phase 1, participants within each treatment arm will again be randomly allocated to receive either monthly chiropractic chronic pain management for 10 months or no scheduled chiropractic visits (Phase 2). Assessments will be collected electronically. The Roland Morris Disability Questionnaire will be the primary outcome for Phase 1 at week 10 and Phase 2 at week 52.
Summary: This trial will provide evidence to guide the chiropractic dose in an initial course of care and an extended-care approach for veterans with chronic low back pain. Accurate information on the effectiveness of different dosing regimens of chiropractic care can greatly assist health care facilities, including Veterans Affairs, in modeling the number of doctors of chiropractic that will best meet the needs of patients with chronic low back pain.
Keywords: Chiropractic; Low Back Pain; Nonpharmacologic; Pain Management; Pragmatic Clinical Trial; Veteran.
From the FULL TEXT Article:
Low back pain (LBP) is the leading global cause of years
lived with disability , with a point prevalence of 20%
in US adults, including 13% with chronic LBP (cLBP). [2, 3] Low back and neck pain were the health conditions
responsible for the highest amount of US health
care spending in 2016.  Most older veterans with pain
have a diagnosis of LBP and report pain-related disability,
high pain intensity, and the presence of pain on most
days of every month.  Another study found that at
least 50% of veterans receiving care in US Department of
Veterans Affairs, Veterans Health Administration (VA)
facilities were diagnosed with a musculoskeletal condition,
and these conditions are increasingly being diagnosed
in younger veterans.  Veterans diagnosed with
pain conditions report high rates of prescription medication
use, including opioids, psychotropics, and sleep
The American College of Physicians currently recommends
nonpharmacological therapies as first-line treatments
for patients with cLBP, several of which are common approaches used by doctors of chiropractic (DCs).  DCs are licensed health professionals who provide nonpharmacological, multimodal, conservative care focused on the management of musculoskeletal conditions, most often LBP.  DCs are best known for their emphasis on spinal manipulation as a treatment modality, but they routinely provide other manual therapies, recommendations for active interventions, education, and self-management advice. 
Chiropractic care is a well-integrated, nonpharmacological
therapy in the VA. [10, 11] Since initial implementation
in 2004, the VA has expanded its delivery of
chiropractic care to 148 facilities.  Use of chiropractic
care in the VA has been growing at ~ 18% per year,
and in Fiscal Year 2019 >300,000 chiropractic visits
were provided to >66,000 individual veterans. However,
important knowledge gaps remain regarding optimal
dose (i.e., the number and frequency of DC visits) for the
The majority of randomized controlled trials (RCTs)
evaluating spinal manipulation in general, and chiropractic
care in particular, for cLBP have focused on short-term
effects (two to six weeks) with highly variable treatment
schedules in terms of the number of visits.  The average
annual number of visits by patients to a DC in the private
sector varies widely but generally ranges between six
and 12.  Respondents to a recent Gallup study who
had seen a DC within the past year reported an average of
11 visits annually.  The only RCT designed to evaluate
dose for patients with cLBP found that 12 chiropractic
care sessions conveyed the optimum benefit when compared
with zero, six, or 18 visits.  However, the generalizability
of this light-massage-controlled efficacy study
to chiropractic practice in real-world settings, especially
for veterans, is unknown. In the VA, the mean number of
visits per year is five , while an integrated care pathway
developed by our team using a modified Delphi process
recommends eight to 12 visits. 
Even less is known about the effectiveness of longerterm
care or chiropractic chronic pain management (CCPM; sometimes referred to as “maintenance” or “extended” care) intened to prevent new episodes of LBP and/or to maintain high function.  This is an important
gap in evidence because the greatest risk factor
for experiencing an episode of LBP is history of LBP , and between 50% and 70% of those with LBP suffer a recurrence within 12 months. [20, 21] A small cadre of studies on CCPM for patients with cLBP, including two small pilot studies and one RCT of 328 participants, indicate that CCPM may improve outcomes. [22–25] However, these studies did not focus on veterans and were conducted outside the United States.
The trial has two primary objectives.
Objective 1: Evaluate the effectiveness of a low dose (one to five visits) of chiropractic care compared with a higher dose (eight to 12 visits) in veterans with cLBP at 10 weeks;
Objective 2: Evaluate the effectiveness of CCPM (one scheduled chiropractic visit per month X 10 months) compared with no CCPM following the initial treatment period of
10–weeks at 52 weeks.
This pragmatic, parallel-group, multisite randomized
trial will include 766 veterans with cLBP who are randomly
allocated to undergo a course of low- or higher-dose
multimodal, evidence-based chiropractic care for
10–weeks (Phase 1). After Phase 1, participants within
each treatment arm will again be randomly allocated to
receive either CCPM or no CCPM for 10 months (Phase
Figure 1 visually describes the pragmatic nature of the trial.  We consider Phases 1 and 2 as separate but linked trials as they each have different interventions, primary outcomes, and random allocations.
Veterans 18 years and older reporting cLBP, defined as
LBP persisting for three or more months with pain on at
least half the days in the past six months , will be eligible. The eligibility criteria in Table 1 reflect a largely
Screening, Recruitment, and Randomization
Based on our pilot study , we anticipate screening
2,000 candidates to accomplish our target enrollment of
766 veterans. We will oversample women, who currently
comprise 15.8% of patients seen in the VA chiropractic
clinics annually , targeting a minimum of 20% female
veterans. We will also target veterans with diverse
ethnic and racial minority backgrounds at rates proportionate
to the veterans seen in our geographically dispersed
VA chiropractic clinics.
We will build upon three successfully piloted methods  to identify and recruit participants for the trial:
1) provider referral, including patients consulted for a first chiropractic visit;
2) invitational letter generated from the VA electronic health record (EHR); and
3) community-based outreach with informational materials.
All or a subset of these strategies may be used.
Based on our pilot study , we anticipate that the
majority of participants will be recruited through provider
referral. Veterans who have been consulted to the
chiropractic clinic as part of routine care, but not yet
seen, will be identified through VA EHR reports.
Candidates will be mailed a letter to determine their interest
in the study. Study team members will regularly
share trial information with VA primary care physicians
and other health professionals to promote referrals.
Promotional materials created for the community-based
outreach strategy will be placed in clinics that commonly
refer veterans for chiropractic care and area veteran
For all recruitment strategies, the site study coordinator
will conduct a phone screen to determine initial eligibility
(Figure 2). Those who are preliminarily eligible will
have a baseline visit scheduled up to 10 days before or on
the day of the initial chiropractic visit. At the baseline
visit, veterans will provide written informed consent,
followed by an eligibility interview to verify participant
eligibility status, collection of demographics, and confirmation
of contact information. Participants will then complete the baseline assessments in REDCap (Vanderbilt University, Nashville, TN, USA), a secure, HIPAA-compliant, Web-based application. At the initial chiropractic visit, participants will undergo clinical evaluation by a site DC to determine if chiropractic care is indicated and verify that an ICD-10 LBP diagnosis code is consistent with neuromusculoskeletal LBP. Eligibility criteria are listed in Table 1 .
Because all consented participants have been referred to the chiropractic clinic, those found ineligible will receive routine care in the chiropractic clinic, as clinically warranted, but will not be retained in the trial. At the end of the initial chiropractic visit, the study coordinator will randomly allocate eligible participants to one of the two treatment groups in Phase 1 and assist in scheduling visits per group assignment. After participants end Phase 1 by completing the week 10 assessment, the study coordinator will contact them, confirm
continued interest in participation in Phase 2, and
randomly allocate them to either CCPM or no CCPM. Group allocation for both Phases 1 and 2 will occur through a 1:1 ratio by a predetermined, computergenerated, restricted randomization scheme with random block sizes, stratified by site and sex. A biostatistician independent of the study team will prepare the randomization scheme, which will be stored in the treatment allocation module of REDCap. Future group assignments for both phases are concealed from participants and trial personnel.
The four participating VA chiropractic clinics are located
in Iowa City, Iowa, West Haven, Connecticut, Los
Angeles, California, and Minneapolis, Minnesota.
Chiropractic care will be provided by licensed DCs who
are fully credentialed and privileged by the VA. DCs will
have access to an evidence-based clinical decision aid for
the treatment of back pain  that will serve as an information
resource, but have the autonomy to treat
patients based on their own clinical judgment, including
the development of individualized treatment plans.
Evidenced-based chiropractic interventions include five
general categories applied individually depending on diagnosis,
patient preferences, and other individual factors.
1) education to inform patients about their condition and to foster health literacy;
2) passive interventions, such as spinal manipulation and myofascial therapies;
3) transitional interventions, which are monitored or guided by a health professional but performed by a patient during active care, such as therapeutic exercises;
4) active interventions, which are controlled and performed by a patient, such as general exercise and mind–body therapies; and
5) self-management advice designed to help patients self-monitor and self-manage symptoms to reduce the impact of a condition over time. 
We anticipate that the most common manual therapies
will include spinal manipulation. For Phase 2, we anticipate
that care during CCPM visits will be similar to
care that occurred during Phase 1, although there may be
a greater emphasis on active care and self-management.
Participants will have access to the same usual VA
medical care available to all veterans during the study.
Acupuncture is delivered by some DCs at our four VA
sites but is not routinely included as part of chiropractic
care in the VA. To maintain our focus on routine chiropractic
care, we will ask DCs and participants not to include
acupuncture as part of the treatment plan.
DCs, site study coordinators, and participants will not be
blinded to treatment group assignment. DCs will be
blinded to research outcome measures; statisticians will
be blinded to treatment group assignment during data
analysis; and research personnel conducting computerassisted
telephone interviews (CATIs) will be blinded to
Baseline and Follow-up Procedures
Participants will complete assessments at the baseline
visit and receive e-mail invitations for subsequent followups
that include a link to their REDCap forms. If a participant
cannot complete the online assessment, research
personnel will contact the individual to complete a
CATI. In addition, participants will receive weekly text
messages asking the number of days in the past week
with LBP and the three questions from the Pain,
Enjoyment of life, and General activity (PEG) scale for
Primary and Secondary Outcomes
The outcome assessment schedule is shown in Table 2.
The primary outcome is the Roland Morris Disability Questionnaire (RMDQ), the patient self-report one-page modified 24–item version, to assess LBP-related disability. It has documented reliability and validity, ease of use, patient acceptance, and is sensitive to clinical change. [30, 31]
We will administer secondary outcomes that measure
other aspects of physical, mental, and social health
domains. The PEG is a three-item chronic pain severity
tool that includes items assessing average pain intensity, interference with enjoyment of life, and interference with
general activity.  For the PEG, we have instructed
participants to consider their LBP in responding to the
We will use computerized adaptive testing to
collect the following Patient-Reported Outcomes Measurement Information System (PROMIS) measures :
pain interference, physical function, fatigue, sleep disturbance, anger, and satisfaction with social roles and activities.
We will also collect PROMIS domains for neuropathic and nociceptive pain quality, self-efficacy for managing symptoms, and global health. Our REDCap
Library will use the Assessment Center Application
Programming Interface to calculate domain-specific
T-scores, which are normed to a mean of 50 and SD of
10 based on the 2000 US general Census. 
The following legacy instruments will measure aspects
of mental health. The Patient Health Questionnaire
(PHQ-8) will assess depressive disorder.  The
Generalized Anxiety Disorder–7 (GAD-7) will assess generalized
anxiety disorder.  The PTSD Checklist-5
(PCL-5) will assess PTSD symptoms.  The Alcohol
Use Disorders Identification Test (AUDIT-10) is a screening
questionnaire to determine harmful or hazardous
consumption of alcohol, correctly classifying 95% of
people as having a clinical diagnosis of an alcohol abuse
Chronic LBP will be determined by a
two-item instrument. 
A three-item instrument recommended by the
Centers for Disease Control and Prevention will define
more general chronic pain. 
We will administer the Use of Nonpharmacological
and Self-care Approaches (NSCAP), a nine-domain questionnaire
developed through the NIH-DOD-VA Pain
Management Collaboratory, to assess complementary
and integrative health approaches for pain. We will also
assess other self-care strategies for LBP care through a
questionnaire developed from previous LBP studies. [39, 40]
We will administer
Expectations for Complementary and Alternative Medicine Treatments (EXPECT) at two
time points to assess individuals’ expectations of treatment
for their cLBP.  We modified “complementary
and alternative medicine,” phrasing in the instrument to
The Healing Encounters and Attitudes Lists (HEAL), a validated item bank comprised of six patient-centered domains developed through PROMIS methodology , will assess nonspecific factors
known to influence patient outcomes. We will also
collect information to screen for serious adverse events
(SAEs) and obtain participant reactions and discomforts.
Sample Size Determination
We first estimated sample size for the two comparisons
of interest for Objective 2 at 52weeks: Phase 1 low dose,
CCPM vs no CCPM; Phase 1 higher dose, CCPM vs no
CCPM. Using the SD of 4.5 (estimated from preliminary
data ) and a 0.05 level of significance, 107 participants
per each of these four groups gives us 90% power
to detect a 2.0–point difference  between groups on
the RMDQ, the primary outcome variable. We then inflated
n=107 per group to account for a 20% loss to
follow-up in Phase 2 of the study, resulting in 134 participants
per each of four groups. Working backwards, we
collapsed the four groups into the two groups for Phase 1
(Objective 1: low-dose vs higher-dose chiropractic care)
and inflated n=268 (134 X 2) by 30% to account for
20% dropout and 10% of participants choosing not to
be randomized into Phase 2, resulting in 383 participants
per group, for a total sample size of 766. For Objective 1,
assuming 30–40% of the low-dose group will achieve a
clinically meaningful improvement on the RMDQ, this
sample size provides 90–96% power to detect at least a
15% difference (relative risks = 1.4–1.5) between the
low- and higher-dose groups. Figure 2 shows the sample
sizes in each phase.
Data Analysis Plans
Data analysis will use an intention-to-treat approach in
which participants will be analyzed according to their
assigned treatment groups. All observed data will be used
in the analyses. Data analyses will be performed using
SAS (SAS Institute Inc., Cary, NC, USA). Descriptive statistics
of demographic and LBP history variables will be
presented by group for each site and by group with all
sites combined. Descriptive statistics of outcome variables
will be presented by group and site over time and by
group over time for all sites.
The primary outcome of achieving a clinically meaningful
improvement on the RMDQ (30% relative to baseline)
at week 10 will be modeled with a modified
Poisson regression with robust error variance fit through
general estimating equations with an unstructured covariance
matrix over baseline, week 5, and week 10. We
will include terms in the model for these three time
points (as a categorical variable), treatment group, and
time X treatment group interaction, adjusting for site,
sex, age, and baseline LBP intensity. We will report the
estimated relative risk of higher-dose vs low-dose chiropractic
care at week 10 from this model with 95% confidence
We will model RMDQ with a linear mixed-effects regression
over baseline and weeks 5, 10, 26, 40, and 52. We
will include terms in the model for these six time points
(as a categorical variable), treatment group, and time X
treatment group interaction, adjusting for site, sex, age,
and baseline LBP intensity. We will report model-based means and 95% confidence intervals of between-group
differences for the two comparisons of interest: Phase 1
low dose, CCPM vs no CCPM, and Phase 1 higher dose,
CCPM vs no CCPM at week 52. Secondary outcomes for
both Objectives 1 and 2 will be analyzed as continuous
variables with linear mixed-effects regression models.
Procedures for Handling Missing Data
We will adjust the models for covariates related to missing
data. For the analyses of both Objectives 1 and 2, we will
conduct sensitivity analyses to examine the possible effects
of missing data. We will use multiple imputation methods
based on assumptions of missing at random and missing
not at random. We will use the tipping point approach for
investigating different patterns of missing not at random.
Adverse Event Procedures
Participants will be instructed to notify the site study coordinator if they experience any side effects or adverse events
following treatment. For adverse events happening during
exam or treatment, the DCs will initiate appropriate clinical
protocols and report related information to the study
coordinator. We will formally inquire about all adverse
events during the assessments according to the schedule in
Table 2. We will screen for SAEs with questions about
hospitalization, life-threatening disease, and significant
change in health status. The study coordinator will follow
up with participants responding yes to any of these questions
to obtain additional information with standardized
questions. All reported adverse events will be reviewed
centrally by a clinician on the research team, who will also
oversee grading of severity and expectedness.
Implementation and Dissemination Procedures
We will report our trial results at key scientific conferences,
at national meetings of the VA Health Services
Research and Development pain management research
community, and to the VA chiropractic field and publish
our results in high-impact journals. To inform VA policymakers,
we will prepare an executive summary to brief
the Deputy Chief Patient Care Services Officer for
Rehabilitation and Prosthetic Services and other relevant
Due to the COVID-19 pandemic, our VA chiropractic
clinic sites have not been providing in-person patient care
since March 2020. As they begin to resume operation,
effects on participant recruitment and intervention delivery
may cause the need to make modifications to our
Lack of information on optimal dosing is a significant
barrier to planning and operationalizing the continued
implementation of VA chiropractic services. Currently,
few published data are available to guide the development of DC staffing models that would provide
optimal access to care for veterans with cLBP. The
extended-care approach of CCPM is not currently used
in the VA, in part because of the lack of studies conducted
in the United States demonstrating its effectiveness.
Accurate information on the effectiveness of
different dosing regimens of chiropractic care could
greatly assist health systems, including the VA, in modeling
the number of DCs that will best meet the needs of
patients with cLBP.
This manuscript is a product of the NIH-DOD-VA Pain
Management Collaboratory. For more information
about the Collaboratory, visit https://painmanagementcollaboratory.
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