J Osteopath Med 2023; 123(5): 259–267

Neuromusculoskeletal Medicine (OMT) Original Article

John C. Licciardone*, DO, MS, MBA, FACPM, Samuel Moore, BS, Kassidy Fix, BS,
Lillian Gowen Blair, MS and Khanh Ta, BS

Osteopathic manipulative treatment of patients

with chronic low back pain in the United States: a
retrospective cohort study
https://doi.org/10.1515/jom-2022-0212 0.36; 95% confidence interval [CI], 0.21–0.63; p<0.001), cigarette
Received October 20, 2022; accepted January 10, 2023; smokers (OR, 0.56; 95% CI, 0.33–0.93; p=0.02), and nonsteroidal
published online February 3, 2023
anti-inflammatory drug users (OR, 0.59; 95% CI, 0.43–0.81;
p=0.001) were less likely to have utilized OMT in the multi-
Abstract
variable analysis. Mean between-group differences among 753
Context: The practice of osteopathic manipulative treat- participants with no OMT crossover and complete follow-up
ment (OMT) varies substantially across nations. Much of this favored OMT: 1.02 (95% CI, 0.63–1.42; p<0.001) for pain in-
variability may be attributed to disparate international tensity; 5.12 (95% CI, 3.09–7.16; p<0.001) for pain impact; 3.59
educational, licensing, and regulatory environments that (95% CI, 2.23–4.95; p<0.001) for physical function, and 2.73 (95%
govern the practice of osteopathy by nonphysicians. This is CI, 1.19–4.27; p<0.001) for health-related quality of life. Ana-
in contrast with the United States, where osteopathic phy- lyses involving propensity-score adjustment and inclusion of
sicians are trained to integrate OMT as part of comprehen- participants with missing data yielded similar conclusions.
sive patient management. None of 12 prespecified participant characteristics demon-
Objectives: This study will analyze the factors associated strated an OMT interaction effect.
with OMT use and its outcomes when integrated within the Conclusions: OMT integrated within medical care provided
overall medical care for chronic low back pain (CLBP) pro- by osteopathic physicians for CLBP was associated with
vided by osteopathic physicians in the United States. improved pain and related outcomes. Its use may be facili-
Methods: A retrospective cohort study was conducted tated by the growing osteopathic physician workforce in the
within the Pain Registry for Epidemiological, Clinical, and United States and adherence to relevant clinical practice
Interventional Studies and Innovation (PRECISION) from guidelines.
April 2016 through April 2022 to study the effectiveness of
OMT integrated within medical care provided by osteopathic Keywords: back-related disability; chronic low back pain;
physicians. The outcome measures, which included pain health-related quality of life; osteopathic manipulative
intensity, pain impact, physical function, and health-related treatment; pain impact; retrospective cohort study.
quality of life, were assessed with the National Institutes of
Health Minimum Dataset, Patient-Reported Outcomes Mea- The Global Burden of Disease Study identified low back pain
surement Information System, and Roland-Morris Disability as being highly prevalent and the leading cause of years
Questionnaire. lived with disability [1, 2]. Such disability usually occurs with
Results: A total of 1,358 adults with CLBP entered the cohort progression from acute to chronic low back pain (CLBP). The
(mean age, 53.2 years; 74.4% female), 913 completed the Centers for Disease Control and Prevention (CDC) has
final quarterly encounter, 348 were in various stages of disseminated broad guidelines for the treatment of chronic
follow-up, and 97 had withdrawn. Blacks (odds ratio [OR], pain that recommend utilizing nonpharmacological treat-
ments and nonopioid therapies as first-line interventions [3].
The American College of Physicians guideline on noninva-
*Corresponding author: John C. Licciardone, DO, MS, MBA, FACPM, sive treatments similarly recommends nonpharmacological
University of North Texas Health Science Center, 3500 Camp Bowie
treatments, including spinal manipulation, and nonsteroidal
Boulevard, Fort Worth, TX 76107, USA, E-mail: [email protected]
Samuel Moore, BS, Kassidy Fix, BS, Lillian Gowen Blair, MS and Khanh
anti-inflammatory drugs (NSAIDs) prior to considering tra-
Ta, BS, University of North Texas Health Science Center-Texas College of madol, duloxetine, or opioids for patients with CLBP [4].
Osteopathic Medicine, Fort Worth, TX, USA These recommendations support the clinical practice
Open Access. © 2023 the author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License.
260 Licciardone et al.: OMT in the United States

guidelines issued by the American Osteopathic Association, cohort. Our hypothesis was that OMT integrated within CLBP
which state that low back pain should be treated with oste- care provided by osteopathic physicians would provide sig-
opathic manipulative treatment (OMT) if somatic dysfunc- nificant treatment effects in pain and other outcomes,
tion is the cause of pain [5, 6]. including health-related quality of life.
There are almost 200,000 clinicians delivering osteo-
pathic care worldwide in 46 nations [7], including over
134,000 osteopathic physicians in the United States [8]. In
contrast with the United States, where osteopathic physi-
Methods
cians integrate OMT within their medical care, “osteopathy”
Study design and participants
is often practiced internationally by nonphysicians under
widely varying educational, licensing, and regulatory envi-
A retrospective cohort study was utilized to measure the clinical out-
ronments [9]. Virtually all systematic reviews of OMT trials comes of OMT over 12 months. Participants were selected from the Pain
have been performed by international investigators and Registry for Epidemiological, Clinical, and Interventional Studies and
include a large representation of studies involving osteop- Innovation (PRECISION) from April 2016 through April 2022. Registry
athy [10]. In these reviews, osteopathy is often provided as participants were screened and recruited from the 48 contiguous states
alternative medicine, or as a complementary treatment that and the District of Columbia, primarily through social media. Registry
data were self-reported by participants at quarterly encounters utilizing
is not integrated within medical care provided by osteo-
a digital research platform and electronic data capture. Eligible registry
pathic physicians. Collectively, these systematic reviews participants ranged from 21 to 79 years of age at enrollment, had suffi-
have provided only marginal evidence supporting such cient English language proficiency to complete case report forms inde-
OMT, and they are generally limited to pain and functioning pendently or with staff assistance, were not pregnant, and did not reside
outcomes over a few weeks or months among patients with in institutional facilities. For inclusion, registry participants must have
low back pain. An international trial similarly found that reported CLBP according to criteria established by the National In-
stitutes of Health Task Force on Research Standards for Chronic Low
OMT for low back pain delivered by nonphysician osteo-
Back Pain (NIH-RTF) [16]. These criteria require having low back pain for
paths had small treatment effects that were not likely clini- at least the past 3–6 months and with a frequency of at least half of the
cally meaningful [11]. days in the past 6 months. Participants were also required to have a
Methodological limitations have also hampered clinical physician who regularly provided CLBP treatment. This research was
trials of OMT for low back pain in the United States. An early approved by the North Texas Regional Institutional Review Board
trial found no significant effect after 3 weeks when OMT was (protocol 2015-169), and all participants provided informed consent
prior to contributing data. This study is reported following the
provided by a “trained manipulator” at the discretion of a
Strengthening the Reporting of Observational Studies in Epidemiology
different treating physician [12]. Another trial found no
(STROBE) guidelines [17]. Further information about PRECISION is
significant effects after 3 months when OMT was provided by available at ClinicalTrials.gov [18].
osteopathic physicians as a complementary treatment for
patients who received all other low back pain care from
other physicians [13]. A third trial found no significant effects Treatments for low back pain
over 6 months, compared with sham manipulation, when
OMT was provided by osteopathic medical students [14]. The use of OMT was determined by participant reporting of their
physician type (osteopathic or allopathic) and current or prior use of
Finally, significant effects pertaining to pain, but not phys-
spinal manipulation to treat low back pain at registry enrollment.
ical function or general health, were observed over 12 weeks Consistent with terminology espoused by the National Center for Com-
when OMT was provided by osteopathic physicians as plementary and Integrative Health [19], the generic term “spinal
complementary treatment for patients who received all manipulation” is utilized by the registry because it is more universally
other low back pain care elsewhere [15]. Thus, no trial to date recognized than the term “osteopathic manipulative treatment,” or
has studied OMT as part of the overall medical care provided OMT, although the latter includes manual techniques other than spinal
manipulation. Because the registry does not collect data on the specific
by osteopathic physicians for low back pain.
type of spinal manipulation provider, participants who were currently
The purpose of this study was to measure the effec- treated by an osteopathic physician and reported utilizing spinal
tiveness of OMT when osteopathic physicians utilize it as manipulation were classified as OMT users. Participants were classified
part of a comprehensive approach to CLBP care. To over- as OMT nonusers if they were treated by an allopathic physician or by an
come the aforementioned methodological difficulties in osteopathic physician without current or prior use of spinal manipu-
lation. Since September 2016, registry participants have been required
performing a rigorous randomized controlled trial in this
to have a physician (i.e., osteopathic or allopathic physician) who
setting over the past 40 years, we conducted a retrospective explicitly treats their low back pain as a condition of enrollment. Thus,
cohort study within a national pain research registry with the registry does not collect data on the use of chiropractic, as this
propensity-score adjustment for OMT use upon entry to the modality is unlikely to be provided by either osteopathic or allopathic
 Licciardone et al.: OMT in the United States 261

physicians. The current use of NSAIDs and opioids for low back pain was upon entry to the cohort, computed with the aforementioned multiple
also measured at registry enrollment. logistic regression model to control for confounding by indication. This
is particularly useful in observational studies of treatment effect,
wherein randomization is not possible, to control for important factors
Outcome measures that may differentiate treatment users and nonusers [24]. In a series of
sensitivity analyses, linear mixed models were utilized to study out-
The four outcome measures were recommended by the NIH-RTF [16]. A comes among participants without OMT crossover, but with either
numerical rating scale ranging from 0 to 10 was utilized to measure complete or incomplete quarterly encounter data.
average low back pain intensity during the 7 days prior to a registry A series of subgroup analyses were performed, each including the
encounter. Pain impact was measured utilizing nine items on the Min- unadjusted and adjusted analyses described above, to identify OMT
imum Dataset recommended by the NIH-RTF, including pain intensity interaction effects involving the 12 prespecified variables in the multiple
and eight items derived from the Patient-Reported Outcomes Mea- logistic regression model. Data management and analyses were per-
surement Information System (PROMIS) [20, 21]. These included four formed with the IBM SPSS Statistics (Version 28) software. Hypotheses
items in each of two PROMIS scales involving physical function and pain were generally tested at the 0.05 level of statistical significance utilizing
interference with activities within the 7 days prior to an encounter. Pain two-sided tests. However, because the subgroup analyses estimated
impact scores may range from 8 to 50. The Roland-Morris Disability OMT effects for four outcomes (pain intensity, pain impact, physical
Questionnaire (RMDQ) was utilized as a legacy measure of physical function, and health-related quality of life) within 25 subgroups
function [16]. It consists of 24 items that measured back-related (100 comparisons), a Bonferroni-corrected significance threshold of
disability on an encounter date, with scores ranging from 0 to 24 [22]. p<0.001 was utilized to interpret the results. Similarly, a Bonferroni-
Health-related quality-of-life measures included four PROMIS scales in corrected significance threshold of p=0.001 was utilized to interpret the
the Minimum Dataset (sleep disturbance, pain interference, depression, OMT interaction effects involving the four outcomes and 12 prespecified
and low energy/fatigue) and a fifth PROMIS scale to measure anxiety. subgroup variables (48 comparisons).
Collectively, 20 items (four items in each PROMIS scale) comprise the
SPADE cluster (sleep disturbance, pain interference, anxiety, depres-
sion, and low energy/fatigue) that measures health-related quality-of-
life deficits. All SPADE scale scores, except sleep disturbance, are
Results
normed according to the general US population and have a mean of 50
and standard deviation (SD) of 10 [20]. The sleep disturbance scale is Participant characteristics and OMT use
similarly scored; however, it is normed with a calibration sample
enriched for chronic illness. The SPADE cluster score is the mean of its The mean (SD) age of 1,358 participants was 53.2 (13.1) years,
five scales and may range from 38 to 77. Each of the four study outcomes and 1,010 (74.4%) were female. There were 187 (13.8%) par-
was measured at registry enrollment and at up to four quarterly en-
ticipants who utilized OMT at registry enrollment. Black
counters over 12 months. Higher scores on each measure represent
worse outcomes. race, cigarette smoking, depression, and NSAID use were
each inversely associated with OMT use (Table 1). In the
multivariable analysis that controlled for potential con-
Statistical analysis
founders, participants who were Black (OR, 0.36; 95% CI,
0.21–0.63; p<0.001), cigarette smokers (OR, 0.56; 95% CI,
Descriptive statistics were utilized to characterize participants at reg-
0.33–0.93; p=0.02), and current NSAID users (OR, 0.59; 95% CI,
istry enrollment. Logistic regression was utilized to compute unadjusted
and adjusted odds ratios (ORs) and 95% confidence intervals (CIs) 0.43–0.81; p=0.001) remained less likely to utilize OMT.
associated with OMT use. The multivariable model included age, gender,
race, ethnicity, cigarette smoking status, chronic widespread pain,
comorbidities (herniated disc, sciatica, depression), low back surgery,
and current medication use for low back pain (NSAIDs, opioids). These
Flow of participants through the study
variables were largely measured utilizing elements of the Minimum and unadjusted outcomes
Dataset [16].
Repeated measures analysis of variance (ANOVA) was utilized to Of 1,358 participants who entered the cohort, 913 (67.2%)
assess each of the four outcomes during 12 months of follow-up. Out- attended the 12-month encounter, 348 (25.6%) were in
comes were measured as between-group differences in means (i.e., in
various stages of follow-up, and 97 (7.1%) had withdrawn
grand means over 12 months) for OMT nonusers minus OMT users.
Hence, positive values favored OMT in all analyses. Cohen’s d statistic (Figure 1). There were 797 participants without OMT cross-
was utilized to assess the clinical relevance of between-group differ- over at the 12-month encounter, including the 753 (94.5%)
ences, with d values ≥ 0.2 considered clinically important [23]. Partici- participants with complete follow-up data in the primary
pants who withdrew from the registry, reported OMT crossover analyses. The OMT users reported better outcomes pertain-
(i.e., entered the cohort in the OMT group and then switched to a
ing to pain intensity, pain impact, physical function, and
physician who did not provide OMT, or vice versa), or missed any
quarterly encounter during 12 months of follow-up were excluded from health-related quality of life (Figure 2). The mean between-
these analyses. Both unadjusted and propensity-score adjusted analyses group differences were: 1.02 (95% CI, 0.63–1.42; p<0.001) for
were performed. The latter included propensity scores for OMT use pain intensity; 5.12 (95% CI, 3.09–7.16; p<0.001) for pain
262 Licciardone et al.: OMT in the United States

Table : Characteristics of participants with chronic low back pain and a treating physician upon enrollment in the registry according to OMT use.

No. (%) Unadjusted Adjusteda

OMT users OMT nonusers

Characteristic (n=) (n=) OR % CI p-Value OR % CI p-Value

Age (years)
–  (.)  (.) Reference Reference
–  (.)  (.) . .–. . . .–. .
–  (.)  (.) . .–. . . .–. .
Gender
Male  (.)  (.) Reference Reference
Female  (.)  (.) . .–. . . .–. .
Race
White  (.)  (.) Reference Reference
Black  (.)  (.) . .–. <. . .–. <.
Other  (.)  (.) . .–. . . .–. .
Ethnicity
Non-Hispanic  (.)  (.) Reference Reference
Hispanic  (.)  (.) . .–. . . .–. .
Cigarette smoking status
Nonsmoker  (.)  (.) Reference Reference
Smoker  (.)  (.) . .–. . . .–. .
Chronic widespread pain
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
Herniated disc
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
Sciatica
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
Depression
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
Low back surgery
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
Current NSAID use
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
Current opioid use
No  (.)  (.) Reference Reference
Yes  (.)  (.) . .–. . . .–. .
a
NSAID, nonsteroidal anti-inflammatory drug; OMT, osteopathic manipulative treatment. Estimates are adjusted for all other variables in the table.

impact; 3.59 (95% CI, 2.23–4.95; p<0.001) for physical function; p=0.001) for pain intensity; 3.12 (95% CI, 1.16–5.08; p=0.002) for
and 2.73 (95% CI, 1.19–4.27; p<0.001) for health-related quality pain impact; 2.24 (95% CI, 0.93–3.56; p<0.001) for physical
of life. These results were clinically important, with Cohen’s function; and 1.55 (95% CI, 0.03–3.07; p=0.045) for health-
d statistics of 0.60, 0.58, 0.61, and 0.41, respectively. related quality of life. The corresponding Cohen’s d statistics
were estimated as 0.37, 0.35, 0.38, and 0.24, respectively.

Propensity-score adjusted outcomes

Sensitivity and subgroup analyses
The use of OMT remained associated with better outcomes
after adjusting for propensity scores (Figure 3). The mean The results of sensitivity analyses that captured available
between-group differences were: 0.62 (95% CI, 0.24–0.99; data for 797 participants without OMT crossover, but with
 Licciardone et al.: OMT in the United States 263

Figure 1: Flow of participants through the study. aRegistry participants were required to have a physician who treated their low back pain beginning in
September 2016.

either complete or incomplete follow-up, were not materi- Expenditure Panel Survey further suggest that providing
ally different than the unadjusted and adjusted results re- OMT within osteopathic medical care may be cost-effective
ported above (Table 2). The direction of the patient subgroup among patients with back and joint problems [29].
results favored OMT in 98 of 100 unadjusted analyses and There were some differences among OMT users and non-
in 97 of 100 adjusted analyses. However, only 43 results in users at registry enrollment. Most notably, Black participants
the unadjusted analyses and 10 results in the adjusted ana- were less likely than Whites to utilize OMT. This is consistent
lyses met the Bonferroni-corrected significance threshold with previous studies of utilization of osteopathic physicians for
(p<0.001) (Supplemental Table 1). No subgroup comparison primary care based on the National Ambulatory Medical Care
demonstrated an OMT interaction effect at the Bonferroni- Survey [30, 31]. Cigarette smokers and NSAID users were also
corrected significance threshold (p=0.001). less likely to utilize OMT. Conversely, the latter finding supports
the view that OMT may have been utilized as an alternative to
pharmacological treatments for low back pain [32].
Discussion The OMT users reported significantly better results than
nonusers in all four outcomes in both the unadjusted and
Although OMT use for any condition has generally declined adjusted analyses. The OMT effects were not only clinically
in the United States over time [25], low back pain has been important but also additive to the effects attributable to
and remains a leading reason to visit osteopathic physicians medical care typically provided by allopathic physicians or
in the National Ambulatory Medical Care Survey [26, 27]. osteopathic physicians who do not utilize OMT. These results
Approximately one-third of patient visits for CLBP in the were corroborated by sensitivity analyses that addressed the
United States are provided by osteopathic physicians [28], potential impact of missing follow-up data. To our knowledge,
suggesting that OMT is an important aspect of the osteo- this is the first study to measure OMT outcomes pertaining to
pathic medical care provided. This is consistent with low CLBP over 12 months, including assessment of pain impact
back pain being the only indication for which the American and health-related quality of life. The latter are emerging
Osteopathic Association recommends OMT in its clinical metrics that capture aspects of the chronic pain experience
practice guidelines [5, 6]. Findings from the Medical not addressed by common or legacy measures [16, 33, 34].
264 Licciardone et al.: OMT in the United States

Figure 2: Unadjusted outcomes during 12 months of follow-up. (A) Pain intensity was measured with a numerical rating scale (range, 0–10). (B) Pain
impact was measured utilizing pain intensity and the physical function and pain interference scales on the Patient-Reported Outcomes Measurement
Information System (PROMIS; range, 8–50). (C) Physical function was measured as back-related disability with the Roland-Morris Disability Questionnaire
(RMDQ; range, 0–24). (D) Health-related quality of life was measured utilizing the SPADE cluster (sleep disturbance, pain interference, anxiety,
depression, and low energy/fatigue) scales on the PROMIS (range, 38–77). Higher scores reflect worse outcomes on each measure. The means and
p values for each outcome are based on 753 participants without OMT crossover and with complete data for all five encounters during 12 months of
follow-up. Error bars represent 95% confidence intervals. OMT, osteopathic manipulative treatment.

Not surprisingly, because the direction of the results growth of the osteopathic profession over the past decade and
involving all four outcomes favored OMT in virtually all acknowledges that OMT may be utilized to treat musculo-
patient subgroups, there were no OMT interaction effects in skeletal disorders, including low back pain, potentially without
the unadjusted or adjusted analyses. Given the overall re- resorting to opioids or other pharmacological treatments [32].
sults, it appears that OMT may be recommended for all adult Extensive training in OMT is required at all colleges of osteo-
patients with CLBP regardless of their demographic or pathic medicine throughout the United States. However,
clinical characteristics. Nevertheless, the findings pertaining maintenance and further development of clinical proficiency
to race are worth noting. Black participants were less likely in OMT among osteopathic residents may be challenged by the
to utilize OMT, and Black participants who utilized OMT did single accreditation system for graduate medical education. In
not report better outcomes than nonusers in any outcome response, curriculum guidelines to meet Accreditation Council
domain. More research is needed to determine if decreased for Graduate Medical Education (ACGME) milestones for
OMT use among Black patients is related to decreased osteopathically recognized residencies have been developed as
awareness of osteopathic physicians [35], or if there are a resource for integrating osteopathic evaluation and treat-
other race-specific factors involved. ment in all residency types [36].
Greater availability and use of OMT may be facilitated by There were several strengths of this study. It was con-
the expanding osteopathic physician workforce. Indeed, the ducted within a national pain research registry utilizing
American Medical Association has recognized the remarkable participants who received OMT in a real-world setting, as
 Licciardone et al.: OMT in the United States 265

Figure 3: Adjusted outcomes during 12 months of follow-up. (A) Pain intensity was measured with a numerical rating scale (range, 0–10). (B) Pain impact
was measured utilizing pain intensity and the physical function and pain interference scales on the Patient-Reported Outcomes Measurement Infor-
mation System (PROMIS; range, 8–50). (C) Physical function was measured as back-related disability with the RMDQ (range, 0–24). (D) Health-related
quality of life was measured utilizing the SPADE cluster (sleep disturbance, pain interference, anxiety, depression, and low energy/fatigue) scales on the
PROMIS (range, 38–77). Higher scores reflect worse outcomes on each measure. The means and p values for each outcome are based on 753 participants
without OMT crossover and with complete data for all five encounters during 12 months of follow-up and are adjusted for the propensity score for
reported OMT use upon entry to the cohort. Error bars represent 95% confidence intervals. OMT, osteopathic manipulative treatment.

integrated within the overall medical care provided by OMT users were less likely to be Black, cigarette smokers, or
osteopathic physicians. This likely contributed to generaliz- NSAID users. To help mitigate such differences, we utilized
ability of the study findings. Outcomes were studied with propensity scores for OMT use upon entry to the cohort to
measures advocated by the NIH-RTF [16], with relatively low minimize confounding by indication. The statistical signifi-
rates of participant withdrawal and missed quarterly en- cance of the findings for all four outcomes remained un-
counters. Moreover, the sensitivity analyses that addressed changed after this adjustment. Moreover, although attenuated,
the potential impact of missing follow-up data demonstrated OMT effects remained clinically important for all outcomes.
findings that were remarkably consistent with the primary Second, one of every eight participants who attended the
results. Electronic data captured through our digital 12-month encounter reported OMT crossover and were
research platform precluded missing item responses during excluded from the primary analyses. In clinical trials involving
completed quarterly encounters. experimental drugs, such participants would have been
Nevertheless, there were study limitations. First, partici- included in an intention-to-treat analysis to address potential
pants were not randomized to initiate OMT at enrollment, as safety signals or other reasons for crossover. However, OMT
would have occurred in a clinical trial. The effects of prior OMT has a record of safety in treating low back pain, and its use is
may have been already evident at enrollment and maintained supported by clinical practice guidelines [3–6]. In our study,
thereafter. Moreover, although OMT users and nonusers were OMT crossover was more likely related to extraneous factors
comparable on many demographic and clinical characteristics, such as the mobility of the population. An unplanned post-hoc
266 Licciardone et al.: OMT in the United States

Table : Outcomes of OMT according to method of analysis.

Unadjusted Adjusteda

Outcome/method of analysis Δb % CI p-Value d Δ % CI p-Value d

Pain intensity
Repeated measures ANOVA (n=)c . .–. <. . . .–. . .
Linear mixed methods (n=)d . .–. <. . . .–. . .
Pain impact
Repeated measures ANOVA (n=) . .–. <. . . .–. . .
Linear mixed methods (n=) . .–. <. . . .–. . .
Physical function
Repeated measures ANOVA (n=) . .–. <. . . .–. <. .
Linear mixed methods (n=) . .–. <. . . .–. <. .
Health-related quality of life
Repeated measures ANOVA (n=) . .–. <. . . .–. . .
Linear mixed methods (n=) . .–. <. . . .–. . .

ANOVA, analysis of variance; CI, confidence interval; OMT, osteopathic manipulative treatment. aEstimates are adjusted utilizing propensity scores for
reported OMT use upon entry to the cohort based on age, gender, race, ethnicity, cigarette smoking status, chronic widespread pain, comorbidities
(herniated disc, sciatica, depression), low back surgery, and current medication use for low back pain (nonsteroidal anti-inflammatory drugs, opioids).
b
Represents the mean difference between OMT users and nonusers. Positive values favor OMT. cIncludes participants without OMT crossover and with
complete data during  months of follow-up. dIncludes participants without OMT crossover and with either complete or missing data during  months of
follow-up.

analysis found that almost one-third of participants with Research funding: This work was supported by the
OMT crossover changed their residential address during Osteopathic Heritage Foundation (grant number 2021-25).
follow-up. Other potential reasons for OMT crossover may Author contributions: All authors provided substantial
have involved changes in healthcare coverage or access to contributions to conception and design, acquisition of data,
physician networks over time, or physician relocation or or analysis and interpretation of data; all authors drafted the
retirement. Because our study reflected real-life clinical article or revised it critically for important intellectual content;
practice and measured actual OMT use, the primary ana- all authors contributed to the analysis and interpretation of
lyses (analogous to a per-protocol approach) were less data; all authors gave final approval of the version of the
likely to yield biased results owing to OMT exposure article to be published; and all authors agree to be accountable
misclassification than an intention-to-treat approach [37]. for all aspects of the work in ensuring that questions related to
Finally, OMT use was based on participant-reported the accuracy or integrity of any part of the work are
physician type and use of spinal manipulation rather appropriately investigated and resolved.
than on medical records. Participants may not have Competing interests: None reported.
accurately recalled this information or may have received Ethical approval: This study was approved by the North
other forms of spinal manipulation from providers other Texas Institutional Review Board (protocol 2015-169);
than osteopathic physicians. Data on the use of chiro- ClinicalTrials registry number: NCT04853732.
practic or other specific forms of spinal manipulation Informed consent: All participants in this study provided
were not collected by the registry. informed consent prior to entering the study.

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