An Observational Study of Integrated Chronic Pain Management in a Community Health Center
Conditions: Chronic Pain, Spine Disease
Sponsor: Washington University School of Medicine

Accessible Chiropractic Care and an Integrated Multidisciplinary Chronic Pain Team: 
Observational Study of Strategies to Manage Chronic Spinal Pain and Reduce Prescription 
Opioids in a Federally Qualified Health Center 
 
Date: July 1, 2018 
 
Background 
Chronic spinal pain is one of the most common complaints encountered in the United States 
health system (16-18). One multi-center study determined that 31% of primary care visits in 
community settings involved chronic lower back or neck pain (18). Furthermore, the annual 
prevalence of nonspecific neck pain in a Canadian study was estimated to be between 30 and 
50% (26); the global point prevalence of low back pain (LBP) is estimated at around 9%, with an 
estimated 80% lifetime prevalence (9, 10). Out of all 291 conditions studied in the Global 
Burden of Disease 2010 Study, LBP ranked highest in terms of disability (years lived with 
disability), and sixth in terms of disability adjusted life-years (DALYs) (9). In addition to the 
effect on patients, LBP costs the medical system an estimated $260 billion annually, not 
including indirect costs of lower household productivity and days of work lost (6,7).  
The treatment of chronic spinal pain often involves a stepwise approach that includes non-
steroidal anti-inflammatories (NSAIDs), rest, exercise, physical therapy, and sometimes 
prescription opioids (11, 26). Unfortunately, opioid analgesics have failed to demonstrate long-
term efficacy in managing chronic pain, at the cost of numerous adverse effects, including 
addiction and overdose (3). Now at the forefront of public health challenges, opioid-related 
deaths have quadrupled from 1999-2015, with 33,091 deaths attributed to opioid overdoses in 
2015 (11, 12).  
As a response, there have been multiple efforts to study the effects of non-pharmacologic 
treatments for chronic spinal pain. Patients seeking these modalities have been shown to have 
higher satisfaction with their management and lower costs to the health system (14,-16, 19). 
Chiropractic physicians manage patients with chronic spinal pain using non-pharmacologic 
therapies, namely spinal and soft tissue manipulation, work/activity modification, and exercise 
and lifestyle advice. Chiropractic care is a clinically-proven safe and effective strategy for 
managing spinal pain resulting in lower pain scores and increased patient satisfaction with 
minimal adverse events (16, 20, 21, 24). In a recent systematic review, chiropractic care was 
equally effective as physical therapy, but there is only limited evidence of equality with medical 
care (23).  
Low-income patients might be underrepresented in chiropractic clinics. Although there have 
been numerous cited attempts to include underserved patients in chiropractic care, there are few 
studies reporting efficacy of such programs. One Canadian study demonstrated that an urban 
chiropractic clinic could achieve sustainability and effectively reduce spinal pain (25). 
Furthermore, on-site chiropractic care in the workplace has been proven to reduce overall 

healthcare utilization, including emergency department visits, outpatient visits, and radiologic 
images (13). Although no such study known to these authors has been published integrating 
chiropractic care within a federally qualified health center (FQHC), it can be hypothesized that 
this model would improve patient outcomes and satisfaction, while reducing healthcare costs and 
potentially reducing opioid prescriptions. 
Affinia Healthcare is a multi-site FQHC in St. Louis, Missouri serving more than 40,000 patients 
per year. Recently, this organization has developed two unique strategies to manage chronic 
pain: 1) a multidisciplinary pain team and 2) chiropractic care. In 2016, Logan University 
College of Chiropractic began partnering with FQHCs, including Affinia Healthcare, whereby 
chiropractic providers treat patients within these medical homes. Using a flat rate of $10 USD 
per visit, this enhances access to chiropractic care for its low-income population. One goal of this 
study will be to examine the effectiveness of chiropractic care in a low-income urban population 
within a FQHC. 
There have been a few studies reporting the use of integrated multidisciplinary pain teams in 
primary care, which have endorsed this model for its acceptability, affordability, and feasibility 
among the primary care team members (1,2,4,5). These have focused on qualitative outcomes, 
and did not focus on endpoints of opioid dose reduction or reduction in patient pain scores. In 
order to assess the effectiveness of the integrated pain team, this study will investigate pain and 
disability score reductions and opioid weaning success. 
In order to best assess both pain and functional status, this study will use the Pain Disability 
Questionnaire (PDQ) as its validated quantitative assessment tool. As opposed to traditional pain 
scales, it incorporates both psychosocial and functional status components; because of this it is a 
useful survey to assess the impact of interventions to reduce pain and improve function, 
including chronic spinal pain (27, 28). 
 
 
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1. 
Research Question 
 
The overall goal of this project is to determine the effectiveness of two distinct interventions for 
reducing chronic pain and decreasing opioid use in a FQHC. 
Primary Objectives: 
i. 
Determine the PDQ score change over time with either intervention 
ii. 
Determine the proportion of patients who successfully wean off prescription 
opioids  
 
Secondary Objectives: 
i. 
Identify clinical and demographic factors associated with treatment success 
ii. 
Identify patients who can successfully reduce their morphine equivalent dose if 
not able to fully wean from opioids 
iii. 
Determine the proportion of eligible patients that adhere to the recommended 
treatments (by way of attrition rates) 
 
2. 
Methods 
a. Design: This study will be a prospective observational study. There will be no 
randomization. Patients and their primary care provider (PCP) will determine 
their health plans outside of the influence of this proposed study. Once 
determined by their PCP to be candidates for either or both of the two 
interventions (chiropractic care or interdisciplinary pain team), they will be 
scheduled an appropriate appointment. On the day of their appointment, all 
patients will be reviewed by the clinician to determine eligibility. If eligible, they 
will be offered the consent document to enroll in the study. The clinician will then 
be blinded to which patients have consented to participation so as to minimize 
bias. Patients concurrently enrolled in both intervention groups will be included in 
a final subgroup analysis. 
 
b. Control group: For this proposed pilot study, there will be no control group. 
Ideally, a standard care group could be analyzed, but currently, Affinia does not 
have the administrative or IT support to incorporate the PDQ in its workflow or 
medical records. Future studies could be designed and planned with this in mind if 
the initial studies have impactful results. 
 

c. Inclusion/exclusion criteria. 
Inclusion criteria: Individuals with chronic (>90 days) spinal pain at Affinia 
healthcare that have been referred internally to either chiropractic care or the 
integrated multidisciplinary pain team. 
Exclusion criteria: Patients deemed to have non-mechanical spinal pain from 
malignancy, compression fracture, or inflammatory spondyloarthropathy.  
d. The target number of enrolled patients per treatment is 30. Thus approximately 60 
patients will be enrolled. Enrollment period is estimated to be three months, and 
will end when the target participant number is achieved. Patients will be followed 
a total of 6 months. Data analysis may take an additional 3 months. Thus this study 
will take approximately 12 months.  
 
e. Data will be stored both electronically and paper-format. A hardcopy of the Patient 
Disability Questionnaire (PDQ) will be provided. This hardcopy will be used to 
help guide clinical decisions during the visit, and then scanned into the electronic 
health record (EHR). Medications, including opioid prescriptions, will be recorded 
in the EHR. A list of enrolled patients will be kept in Microsoft Excel. 
 
f. Enrolled participants will be tracked in a Microsoft Excel spreadsheet to be stored 
in Affinia Healthcare’s user-specific and password-protected desktop computers 
with drive encryption. In order to track opioid prescriptions, the enrolled patient list 
can be exported to Affinia’s IT department to run a medication search. This 
information will be relayed to the study team to enter in the database. Any 
discrepancies, suspected to be minimal, will require a manual chart review. This 
will be done by someone other than the investigators such as the IT data analyst so 
as to minimize bias. Prior to final data analysis, data will be de-identified. All data 
transactions will be done through secure, encrypted server e-mail. 
 
g. Will the data set include any sensitive information (e.g., HIV status, psychiatric 
diagnosis)? No.  
 
h. Will the data set include any genomic data? No. 
 
i. Will your data be used in collaborative efforts with other institutions? Yes. Patrick 
Battaglia, DC, DACBR and Barry Wiese, DC, MHA, DIBCN, will be co-
investigator from Logan University. The faculty of Logan University who have 
patient privileges at Affinia Healthcare have access to the same EHR and servers, 
and data will remain in the same secure, encrypted locations. 
 
3. 
Study Statistics 
Primary outcome variable: 
i. Difference in PDQ (functional and psychosocial scores) 
ii. Proportion of patients weaned from opioids by the end of study period 
 

Secondary outcome variables: 
i. Odds of treatment success by demographic factor (age, sex, origin, other 
musculoskeletal pain diagnoses, etc.) 
ii. Proportion of patients successfully reduced on morphine equivalent dose (any 
reduction) 
iii. Proportion of eligible patients who adhere to treatment (show rates) 
 
Analysis plan (sample size justification and interim analysis) 
Sample size calculations will be technically challenging due to the observational 
nature of the dual-intervention study design. We will estimate that standard care 
results in 90% failure rate to positively change PDQ scores or wean opioids. We 
will estimate the true relative risk of treatment failure is 0.5. Using the null 
hypothesis that there is no difference between the treatments and that there is no 
difference between either treatment and standard care, our calculations predict that 
16 experimental subjects will be needed per intervention. The proportion of cross-
over patients is unknown, so a conservative 50% will be used, and thus 32 (30 for 
ease of estimation) patients will be needed per group to reject the null (α=0.05, 
power=0.8). We will use the chi-squared statistic to evaluate this null hypothesis. 
Two-sample t-test and multiple linear regression will be conducted to determine the 
demographic and clinical features associated with outcomes. Most demographic 
factors will be binary or categorical, including age.  
Variables to collect 
i. 
Age (categorical) 
ii. Sex 
iii. Preferred language 
iv. Country of origin  
v. 
Insurance (categorical) 
vi. Type of spinal pain (cervical, lumbar) 
vii. Morphine equivalent dose 
viii. Other musculoskeletal pain diagnoses (hip pain, shoulder pain, etc.) 
 
 
4. 
Risks 
a. Address the risk of loss of confidentiality. 
b. Discuss the steps you are taking to minimize this risk. 
c. Discuss your plan for reporting unanticipated problems or study deviations 
 
There are no anticipated medical, legal, or financial risks to the participants.  
There is no randomization and no placebo. Patients will be studied as part of a treatment 
plan dictated independently by their medical providers. Risks to confidentiality will be 
minimized by the following procedures: study records will be accessible only to 
authorized study staff, and the generated data report for analysis will be de-identified. 

Chart reviews will be conducted for enrolled study participants, gathering pre-selected 
variables.  
This study relies upon a steady referral stream to Affinia chiropractic care and the 
pain team. Currently, these are accessible and well-utilized services, but there is no way 
to predict the future trend of these referrals. Any unanticipated change in providers, 
access to the pain team or chiropractic services, or patients refusing participation will 
extend the enrollment period.