Spinal Manipulation Services vs. Prescription Drug Therapy for Long-term Care of Aged Medicare Beneficiaries With Chronic Low Back Pain
Conditions: Low Back Pain
Sponsor: Southern California University of Health Sciences

Spinal Manipulation vs. Opioid Analgesic Therapy for Chronic Low 
Back Pain: Beliefs, Satisfaction with Care, and Qualify of Life among 
Older Medicare Beneficiaries 
 
 
 
Principle Investigator 
Anupama Kizhakkeveettil, PhD. 
Southern California University of Health Sciences 
16200 Amber Valley Drive, Whittier, CA 90604, USA 
(562) 475-5158 - anu@scuhs.edu 
 
 
Co-Principle Investigator 
James M Whedon, DC, MS. 
Southern California University of Health Sciences, Whittier, CA 
jameswhedon@scuhs.edu 
 
 
 
 
 
              Date of the document: June 2 2018 
 
 
 
 
 
 
 
 
 
 
 
 
This research was supported by the National Center for Complementary and Integrative Health 
(NCCIH) of the National Institutes of Health under award number 1R15AT010035. This project 
was 100% federally funded. The content is solely the responsibility of the authors and does not 
necessarily represent the official views of the National Institutes of Health. 

 
METHODS 
 
To test our hypothesis, we conducted a survey among older Medicare beneficiaries with 
cLBP. “X university IRB” approval was received to conduct this study. This study was registered 
under clinical trials.gov website (NCT03669354). 
Population 
Potential survey participants were identified through analysis of Medicare claims data. 
The study population included non-institutionalized Medicare Fee for Service (FFS) 
beneficiaries, either male or female, aged 65-84 years, as of 01/01/2012, and residing in a US 
state or the District of Columbia, and continuously enrolled in Medicare Parts A (inpatient), B 
(outpatient) and D (pharmacy) from 2012 through 2016.We restricted the population to subjects 
with an episode of cLBP beginning in 2013. cLBP has previously been defined as lasting three 
months or longer14, thus, an episode of cLBP was identified by two paid claims for outpatient 
office visits with a primary diagnosis of LBP greater than 90 days but less than 180 days apart. 
Claims were further restricted to the clinician specialties of General Practice, Family Practice, 
Internal Medicine, Osteopathic Manipulative Medicine, Physical Medicine and Rehabilitation, 
Chiropractic, Physical Therapist in Private Practice, or Pain Management. Low back pain was 
identified by ICD-9 or ICD-10 diagnosis codes. We excluded all subjects with any diagnosis of 
cancer or use of hospice care. We assembled an analytic data set of claims for 28,160 
Medicare beneficiaries who met study inclusion criteria. Study subjects were grouped into four 
cohorts as defined below. The research methods were reviewed and approved by the principal 
investigators’ institutional review board. 
Cohort Definitions 
All included patients received long term management of cLBP with SMT or OAT. SMT was 
identified in clinical claims data by by Current Procedural Terminology (CPT) code 98940, 98941, 
or 98942. OAT was identified as opioid analgesics or analgesics containing opioids, identified by 
drug code and obtained by prescription through an outpatient pharmacy. For OAT, we defined 
long-term management as 6 or more standard 30-day supply prescription fills in a 12-month 
period. 15, 16 For SMT, we defined long-term management as >12 office visits for spinal 
manipulation for LBP in any 12-month period, including at least one visit per month. 14 We 
assembled two primary and two crossover cohorts as follows: 
Primary Cohorts 
SMT= Initiation in 2013 of long-term management with SMT, and no OAT for 12 months after initiating SMT 
OAT = Initiation in 2013 of long-term management with OAT, and no SMT for 12 months after initiating OAT 
Crossover Cohorts 
SMTX = Any occurrence of SMT for cLBP in 2013, followed by initiation in 2013 of long-term management 
with OAT 

OATX = Any occurrence of OAT for cLBP in 2013, followed by initiation in 2013 of long-term management 
with SMT 
The date of accrual (index date) for patients into each cohort was the date of the first 
office visit associated with an episode of cLBP. For subjects with more than one episode of 
cLBP, only the first episode was counted for purposes of cohort accrual. 
Survey Procedures 
Following cohort assembly, potential survey participants were selected by random 
sampling of subjects in each of the four cohorts. The list of potential survey participants was 
securely transmitted to the Centers for Medicare and Medicaid Services (CMS), and initial 
contact was made by CMS in the form of a Beneficiary Notification Letter, signed by the CMS 
Privacy Officer. This letter notified the selected Medicare beneficiaries of the opportunity to 
participate in a healthcare survey, and allowed them the option to decline participation via 
enclosed reply forms. Upon conclusion of this process, CMS provided us with contact 
information for beneficiaries that had been determined to be eligible for voluntary participation in 
the survey. CMS provided contact information for 2,490 participants; beneficiaries who were 
deceased or without contact information were removed. A total of 1,986 surveys were hand- 
addressed and mailed to the Medicare beneficiaries on 01/10/2020. All available phone 
numbers were used to make reminder phone calls and two weeks after initial mailing, 1,070 
reminder surveys were re-sent to cohorts with lower response rates. The data was entered into 
an MS Excel spreadsheet, with double data entry and data verification. Patient’s signed consent 
was obtained prior to participate in the study. 
Outcome Measures 
Overall Satisfaction with SMT and PDT 
The survey measured satisfaction for both SMT and PDT on a scale from 0-10, 0 being 
very dissatisfied and 10 being very satisfied. The patients were also given an option to select 
‘not applicable’ if they never experienced either PDT or SMT. Literature indicates that for 
quantifying satisfaction among patients, Numeric Rating Scales can be used. 17-18 
Beliefs about Treatments Received 
This study included an 8-item assessment of participant beliefs regarding their treatment 
of SMT and PDT. These survey items were taken from a validated scale (patient’s treatment 
belief low back pain questionnaire) developed by Dima et al., with permissions from the 
author(s) .19 A modified version of LBP treatment belief questionnaire scale (LBP TBQ Scale) 
was used for this study. An example of a belief question was: “I think spinal manipulation is 
pretty useless for people with back pain,” or “I believe Prescription Drug therapy (PDT) is pretty 
useless for people with back pain.” Responses ranged from Strongly Disagree, Disagree, 
Agree, Strongly Agree and Undecided in a 5-point Likert scale. For purposes of analysis, we 
combined the response options into the following three categories: “Disagree” (Strongly 
Disagree and Disagree), “Agree” (Strongly Agree and Agree), and “Undecided”(left as is). 
Quality of Health Survey (Mental and Physical Health – SF-12) 
A modified version of the SF-12 outcome measure was used. The SF-12 is a validated, 
health-related quality of life (HRQoL) survey. 17,20. The SF-12 is designed to be able to measure 
physical and mental health. We modified the format of the original SF-12 survey to fit our 
population.20 Modifications to the survey included reformatting of the item and response 
presentations, using a larger font size. Permission to use the survey items in our study was 
granted by OPTUM. 

The survey instrument was pre-tested for face validity by administration to 102 Medicare 
patients with chronic low back pain, over the age of 65, who had received at least two 
chiropractic spinal manipulation treatments for their low back pain at the Southern California 
University of Health Sciences’ University Health Center. After examining the face validity of the 
survey, and based on feedback, for ease of comprehension by older subjects, the survey 
questions were printed in larger font and carefully worded to be brief, unambiguous, and free 
from bias. 
Data Analysis 
We generated descriptive statistics including computation of means for continuous 
variables and percentages for categorical data. We examined between-group differences for our 
three measures. Specifically, we first compared outcomes for the SMT and OAT cohorts to test 
our primary hypotheses and subsequently compared outcomes for the SMTX and OATX 
cohorts as exploratory analyses. 
In order to address our primary hypothesis, we collapsed the response options as 
follows: response options for satisfaction with care items, 8-10, we coded as ‘Very satisfied’ and 
response options <8, we coded as ‘Less satisfied’. We conducted Pearson chi-square tests to 
examine differences between groups for the Beliefs about Treatment items as well as for the 
overall satisfaction with treatment items. 
Additionally, for the Beliefs about Treatment items, we combined the response options 
using the following categories: Disagree (combined Strongly disagree with Disagree), Agree 
(combined Strongly agree with Agree), Undecided was left as is. Group mean differences for the 
SF-12 mental and physical health scores were examined using t-tests. We performed t-tests for 
group mean comparisons utilizing the entire 0-10 scale for overall satisfaction as well. 
Additionally, we conducted the Kruskal-Wallis non-parametric test to accommodate non- 
normality in the distribution of the data for the Beliefs about Treatment items . All analyses were 
conducted using IBM SPSS (Version 23).