Original Investigation | Physical Medicine and Rehabilitation

Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical
Care Alone on Pain and Disability Among US Service Members
With Low Back Pain
A Comparative Effectiveness Clinical Trial
Christine M. Goertz, DC, PhD; Cynthia R. Long, PhD; Robert D. Vining, DC; Katherine A. Pohlman, DC, MS; Joan Walter, JD, PA; Ian Coulter, PhD

Abstract

Key Points

IMPORTANCE It is critically important to evaluate the effect of nonpharmacological treatments on
low back pain and associated disability.

Question What is the effect of adding
chiropractic care to usual medical carefor patients with low back pain?

OBJECTIVE To determine whether the addition of chiropractic care to usual medical care results in

Findings In this comparative

better pain relief and pain-related function when compared with usual medical care alone.

effectiveness clinical trial among activeduty US military personnel, patients

DESIGN, SETTING, AND PARTICIPANTS A 3-site pragmatic comparative effectiveness clinical trial

who received usual medical care plus

using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large

chiropractic care reported a statisticallymilitary medical centers in major metropolitan areas and 1 smaller hospital at a military training site.

significant moderate improvement inEligible participants were active-duty US service members aged 18 to 50 years with low back pain

low back pain intensity and disability atfrom a musculoskeletal source.

6 weeks compared with those who
received usual care alone.

INTERVENTIONS The intervention period was 6 weeks. Usual medical care included self-care,
medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative
therapy in the low back and adjacent regions and additional therapeutic procedures such as
rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.

Meaning This trial supports theinclusion of chiropractic care as acomponent of multidisciplinary healthcare for low back pain, as currently
recommended in existing guidelines.

MAIN OUTCOMES AND MEASURES Coprimary outcomes were low back pain intensity (Numerical
Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) anddisability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scoresindicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement,satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely
satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects+ Invited Commentary+ Supplemental content
Author affiliations and article information arelisted at the end of this article.

regression over baseline and weeks 2, 4, 6, and 12.
RESULTS Of the 806 screened patients who were recruited through either clinician referrals or selfreferrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years,
175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statisticallysignificant site × time × group interactions were found in all models. Adjusted mean differences inscores at week 6 were statistically significant in favor of usual medical care plus chiropractic carecompared with usual medical care alone overall for low back pain intensity (mean difference, −1.1;
95% CI, −1.4 to −0.7), disability (mean difference, −2.2; 95% CI, −3.1 to −1.2), and satisfaction (meandifference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also
statistically significant in favor of usual medical care plus chiropractic care overall for perceived(continued)

Open Access. This is an open access article distributed under the terms of the CC-BY License.
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Abstract (continued)

improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (oddsratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported.
CONCLUSIONS AND RELEVANCE Chiropractic care, when added to usual medical care, resulted inmoderate short-term improvements in low back pain intensity and disability in active-duty military
personnel. This trial provides additional support for the inclusion of chiropractic care as a componentof multidisciplinary health care for low back pain, as currently recommended in existing guidelines.
However, study limitations illustrate that further research is needed to understand longer-term
outcomes as well as how patient heterogeneity and intervention variations affect patient responses
to chiropractic care.
TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01692275
JAMA Network Open. 2018;1(1):e180105. doi:10.1001/jamanetworkopen.2018.0105

Introduction
Musculoskeletal disorders are the second leading cause of disability worldwide, led by low back pain
(LBP), with an estimated LBP prevalence among US adults of 20%.1-3 The direct costs of back painin the United States in 2010 were $34 billion,4 with additional indirect costs including lost workplace
productivity estimated at $200 billion.5 In the US military, LBP is one of the most common reasons
members seek medical care6 and one of the most likely conditions to interrupt combat duty.6,7Common medical therapies for LBP, including nonsteroidal anti-inflammatory drugs, opioids, spinal
fusions, and epidural steroid injections, demonstrate limited effectiveness8-10; furthermore, many ofthese treatments have unacceptably high risk profiles.8,11-14
The US opioid crisis15,16 creates an urgent need to evaluate cost-effective and low-risk
nonpharmacological treatments. One option is chiropractic care. Doctors of chiropractic provide
conservative care focused on diagnosis, treatment, comanagement, or referral for musculoskeletal
conditions, including LBP.17 The primary therapeutic procedure used by doctors of chiropractic is
spinal manipulative therapy.18
The use of chiropractic care is common, with annual rates among US adults estimated between
8% and 14%.19,20 Current guidelines recommend the use of spinal manipulative therapy and/or
chiropractic care for LBP.21,22 Although a previous pilot study of chiropractic care for active-duty US
military patients with acute LBP showed promise,23 and chiropractic care is available at 66 military
health treatment facilities worldwide,24 significant gaps in knowledge remain in military populations.
These populations tend to be younger and more diverse in terms of race and ethnicity than thoseincluded in previous trials on spinal manipulation.25 This multisite, pragmatic clinical trial begins toaddress these gaps by investigating whether adding chiropractic care to usual medical care (UMC)
improves outcomes for patients with LBP at military treatment facilities.

Methods
Study Design, Setting, and Participants
A detailed study protocol was previously published,26 and the trial protocol is available in
Supplement 1. This pragmatic, prospective, multisite, parallel-group comparative effectivenessclinical trial with adaptive allocation was conducted at 2 large military medical centers in major
metropolitan areas (Walter Reed National Military Medical Center [hereafter referred to as “Walter
Reed”], Bethesda, Maryland; and Naval Medical Center San Diego [hereafter referred to as “SanDiego”], San Diego, California) and at 1 smaller hospital at a military training site (Naval HospitalPensacola [hereafter referred to as “Pensacola”], Pensacola, Florida). Active-duty US military
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participants aged 18 to 50 years reporting LBP were eligible. Low back pain of any duration from a
nonmusculoskeletal source, the presence of a contraindication to spinal manipulative therapy, recent
spinal fracture, recent spinal surgery, and a diagnosis of posttraumatic stress disorder were
exclusionary. Participants with radiculopathy were eligible if a further diagnostic evaluation or
surgical referral was not necessary. Participants either were referred to the study by physicians who
diagnose or manage LBP or were self-referred through posted advertisements. Physicians or
Independent Duty Corpsmen conducted a screening examination to assess eligibility. The trial wasapproved by each site and participating institution’s institutional review board and was overseen by
an independent data and safety monitoring committee. All participants provided written informed
consent and were not compensated for participation. The study followed the Consolidated
Standards of Reporting Trials (CONSORT) reporting guideline.

Allocation
Participants were allocated in equal proportions to UMC with chiropractic care or to UMC alone for 6
weeks, stratified by site. The data coordinating center programmed an adaptive computergenerated minimization algorithm to balance group assignment on sex, age, LBP duration, and worst
pain intensity in the past 24 hours at baseline. Study personnel accessed the web application to makegroup assignments, and future allocations were concealed.

Study Interventions
Usual Medical CareIn this pragmatic trial, UMC in both groups included any care recommended or prescribed bynonchiropractic military clinicians to treat LBP. Options included self-management advice,
pharmacologic pain management, physical therapy, or pain clinic referral. Participants allocated to
UMC alone were asked to avoid receiving chiropractic care for the active care period unless directedby their clinician. In both groups, frequency of treatment visits and procedures were determined
individually based on the participant’s diagnosis or condition, response to care, and schedulingavailability.
UMC With Chiropractic Care
Participants allocated to UMC with chiropractic care had UMC in addition to as many as 12
chiropractic visits during the active care period. The primary chiropractic procedure was spinal
manipulative therapy in the low back and adjacent regions.18 Treatment decisions regarding
manipulation type, location, and direction were based on patient diagnoses. Other factors included
patient preference, prior response to care, paraspinal muscle hypertonicity, spinal joint hypomobility,
and imaging findings. Additional therapeutic procedures may have included rehabilitative exercise,interferential current therapy, ultrasound therapy, cryotherapy, superficial heat, and other manual
therapies.

Blinding
It was not possible to blind treating clinicians or participants to treatment assignment. However, all
key study personnel and data analysts were blinded.

Outcomes
Sociodemographic and clinical information was obtained at baseline. Participants were classified byrace and ethnicity based on self-report. These data were collected to determine the generalizabilityof study findings, which is important for studies of chiropractic care as previous trials have included
primarily white participants not of Latino descent. Usual medical care data on physical therapy or
specialty referrals and prescription medications for spine-related pain as well as Current Procedural
Terminology codes describing treatments delivered by the doctor of chiropractic were abstracted
from the electronic health record.

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Primary outcomes (eTable 1 in Supplement 2) were measured at baseline and 2, 4, 6, and 12
weeks after baseline via online self-report questions through an electronic data capture system.26
Primary and secondary end points were at 6 and 12 weeks, respectively.
Coprimary Outcomes
Average LBP intensity during the prior week was assessed by the Numerical Rating Scale (NRS; scores
ranging from 0 [no LBP] to 10 [worst possible LBP]).27-29 Functional disability related to LBP wasassessed by the Roland Morris Disability Questionnaire (RMDQ; scores ranging from 0-24, withhigher scores indicating greater disability).30 Primary analyses compared adjusted means between
groups at the primary and secondary end points. A secondary responder analysis compared thepercentage of patients with at least 30% improvement from baseline at each end point.
Secondary Outcomes
Worst LBP intensity during the past 24 hours was assessed using the NRS. Bothersomeness of LBP
symptoms in the past week was measured on a scale of 1 (not at all bothersome) to 5 (extremely
bothersome).31 Pain medication use was collected by asking participants how often they took painrelieving medication (both prescription and over-the-counter) during the past week (0, 1-2, 3-4, 5-6,
or 7 days). Global LBP improvement was assessed by asking participants to rate their perceived LBP
improvement since baseline on a 7-point scale (0 indicated completely gone; 6, much worse).32,33
Satisfaction with care was assessed with an NRS, with scores ranging from 0 (not at all satisfied) to 10(extremely satisfied).

Adverse Events
Adverse events were documented by participants via online self-report questions answered at 2, 4,
and 6 weeks, and from project managers who directly queried participants.

Sample Size
We anticipated that outcomes might vary by site owing to differing patient populations. Therefore,
we calculated a sample size of 106 patients per group per site to provide adequate power to detect
clinically important between-group differences.34 A Bonferroni-adjusted significance level of
α = .025 accounted for the coprimary outcome variables, with standard deviations estimated fromour pilot study. This provided 92% power to detect a between-group difference of at least 1.2 points
on the NRS and 80% power to detect a difference of at least 2.4 points on the RMDQ35 at each site.
We increased the sample size to 125 patients per group at each site to account for an estimated loss
to follow-up of 15% at the week 6 end point.

Statistical Analysis
The data analysis plan was prespecified and is shown in Supplement 1.26 Analyses followed an
intention-to-treat approach in which all participants’ data were analyzed according to their original
treatment allocation. We used SAS/STAT (release 9.4; SAS Institute Inc) for data analyses. All
observed data were used in the analyses. Regression models included terms for time, site, group, andsite × group, time × group, and site × time × group interactions, adjusted for sex, age, pain duration,
and worst pain during the past 24 hours. For all analyses, if the site × time × group interaction was
significant at the α = .05 level, results from the adjusted final models were reported overall andby site.
The coprimary outcome variables were modeled with linear mixed-effects regression overbaseline and weeks 2, 4, 6, and 12. Bonferroni-corrected P ⱕ .025 was used to determine whether
between-group differences were statistically significant at weeks 6 and 12. The responder analyses of
the coprimary outcome variables were modeled with a modified Poisson regression fit throughgeneralized estimating equations.

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Two approaches to sensitivity analyses were used to examine possible effects of missing dataon results of coprimary outcome variables. The first assumed that data were missing at random andthe second was a tipping-point approach that assumed data were missing not at random. Multiple
imputation with the Markov chain Monte Carlo method was used for both methods to impute
missing values for the coprimary outcome variables at weeks 2, 4, 6, and 12.
Continuous secondary outcome variables were analyzed with the same linear mixed-effects
regression models described earlier (except satisfaction, which was collected through week 6), but
P ⱕ .05 was used to determine whether between-group differences were significant. Pain
medication use and perceived global improvement were analyzed over baseline and weeks 2, 4, and6 with a proportional odds model for ordinal categorical data fit through generalized estimating
equations.

Results
Participants and Treatment Visits
A total of 806 patients were screened between September 28, 2012, and November 20, 2015, with
750 (250 at each of the 3 sites) allocated to receive UMC with chiropractic care (375 participants) or
UMC alone (375 participants) (Figure 1). Data collection was completed on February 13, 2016, anddata analysis was conducted from March 7, 2016, through April 30, 2016. Demographic
characteristics, in particular age, race, and LBP chronicity, differed between sites (Table 1). Overall,
the mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243
participants (32.4%) were nonwhite. Forty-three participants (5.7%) reported current use of narcotic

Figure 1. Trial Flow Diagram
806 Individuals assessed for eligibility

56 Excluded
32 Did not meet eligibility criteria
24 Declined to participate

750 Allocated375 Allocated to UMC
273 Attended ≥1 visit with UMC clinician
2 Received chiropractic care during
6-wk active care phase
102 Did not receive UMC

375 Allocated to UMC with chiropractic care
266 Attended ≥1 visit with UMC clinician
not receive
109 Did not Did
receive
UMC UMC319 Completed 2-wk assessment (85%)
16 Lost to follow-up
3 Withdrew from study
302 Completed 4-wk assessment (81%)
5 Lost to follow-up
2 Withdrew from study
340 Completed 6-wk assessment (90%)
1 Lost to follow-up
4 Withdrew from study
316 Completed 12-wk assessment (84%)
26 Lost to follow-up
2 Withdrew from study

334 Completed 2-wk assessment (89%)
11 Lost to follow-up
3 Withdrew from study
321 Completed 4-wk assessment (86%)
3 Lost to follow-up
1 Withdrew from study
342 Completed 6-wk assessment (91%)
7 Lost to follow-up
2 Withdrew from study
309 Completed 12-wk assessment (82%)
36 Lost to follow-up
3 Withdrew from study

375 Included in analysis of coprimary outcomes

375 Included in analysis of coprimary outcomes

350 ≥1 visit with
350 Attended
doctor of chiropractic
15 Did not receive UMC or
chiropractic care
10 Received UMC but had no visits with
doctor of chiropractic

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analgesics and 398 (53.1%) took nonsteroidal anti-inflammatory drugs for back pain. Among all
participants, 439 (58.5%) had never been treated with chiropractic care.
There were 102 participants in the UMC group who did not visit a UMC clinician: 6 at Walter
Reed, 2 at Pensacola, and 94 at San Diego. Of the 273 patients who had at least 1 visit to a UMC
clinician, the mean (SD) number of visits was 2.6 (2.3) at Walter Reed, 2.3 (2.3) at Pensacola, and 2.7(2.5) at San Diego. There were 109 participants in the group receiving UMC with chiropractic care
who did not visit a UMC clinician: 11 at Walter Reed and 98 at San Diego. Of the 266 patients who had
at least 1 visit to a UMC clinician, the mean (SD) number of visits was 2.6 (3.1) at Walter Reed, 1.6 (1.6)
at Pensacola, and 3.5 (3.0) at San Diego. Of the 350 participants who had at least 1 chiropractic visit,
the mean (SD) number of visits was 4.7 (2.5) at Walter Reed, 5.4 (2.6) at Pensacola, and 2.3 (1.4) at
San Diego.

Table 1. Baseline Characteristics of 750 Participants
No. (%)
Walter Reeda

Pensacolaa

San Diegoa

Overall

Characteristic

UMC Alone(n = 125)

UMC + CC(n = 125)

UMC Alone(n = 125)

UMC + CC(n = 125)

UMC Alone(n = 125)

UMC + CC(n = 125)

UMC Alone(n = 375)

UMC + CC(n = 375)

Age, mean (SD), y

34.4 (8.4)

34.7 (8.6)

25.5 (7.9)

25.7 (7.5)

32.4 (7.4)

32.4 (7.5)

30.8 (8.8)

30.9 (8.7)

Male

86 (68.8)

85 (68.0)

106 (84.8)

107 (85.6)

95 (76.0)

96 (76.8)

287 (76.5)

288 (76.8)

Hispanic or Latino

16 (12.8)

9 (7.2)29 (23.2)

12 (9.6)

21 (16.8)

31 (24.8)

66 (17.6)

52 (13.9)

Asian

6 (4.8)3 (2.4)3 (2.4)1 (0.8)11 (8.8)

6 (4.8)20 (5.3)

10 (2.7)

Black or African American

41 (32.8)

42 (33.6)

17 (13.6)

15 (12.0)

14 (11.2)

20 (16.0)

72 (19.2)

77 (20.5)

White

62 (49.6)

62 (49.6)

102 (81.6)

106 (84.8)

88 (70.4)

87 (69.6)

252 (67.2)

255 (68.0)

Other or unspecified

16 (12.8)

18 (14.4)

2 (1.6)7 (5.6)

11 (8.8)

17 (13.6)

31 (8.3)

33 (8.8)<1

42 (33.6)

43 (34.4)

81 (64.8)

80 (64.0)

21 (16.8)

20 (16.0)

144 (38.4)

143 (38.1)

1-3

14 (11.2)

14 (11.2)

17 (13.6)

17 (13.6)

9 (7.2)8 (6.4)40 (10.7)

39 (10.4)>3

69 (55.2)

68 (54.4)

27 (21.6)

28 (22.4)

95 (76.0)

97 (77.6)

191 (50.9)

193 (51.5)

BMI, mean (SD)27.7 (3.9)

27.2 (3.7)

26.0 (3.3)

25.6 (3.5)

26.6 (3.5)

26.8 (3.6)

26.8 (3.6)

26.5 (3.7)

Current smoker

9 (7.2)5 (4.0)28 (22.4)

15 (12.0)

27 (21.6)

17 (13.6)

64 (17.1)

37 (9.9)

Used NSAIDs for LBP
in past wk

82 (65.6)

75 (60.0)59 (47.2)

58 (46.4)

54 (43.2)

70 (56.0)

195 (52.0)

203 (54.1)

Used narcotic analgesics for
LBP in past wk

9 (7.2)12 (9.6)

1 (0.8)4 (3.2)11 (8.8)

6 (4.8)21 (5.6)

22 (5.9)

Never been to a doctor ofchiropractic

70 (56.5)

64 (51.2)

92 (73.6)

84 (67.7)

68 (54.4)

61 (48.8)230 (61.3)

209 (55.7)

NRS score for average LBP
during past wk, mean (SD)b

4.3 (1.7)

4.4 (1.8)

4.7 (2.0)

4.4 (2.2)

4.8 (2.1)

5.0 (2.0)

4.6 (2.0)

4.6 (2.0)

RMDQ score for disability,
mean (SD)c

10.3 (5.4)

9.7 (5.5)

11.0 (5.2)

10.5 (5.9)

8.9 (5.7)

9.3 (5.2)

10.1 (5.5)

9.8 (5.6)

Score of bothersomeness of
LBP, mean (SD)d

3.6 (1.0)

3.5 (1.0)

3.8 (0.9)

3.7 (1.0)

3.5 (1.0)

3.5 (0.9)

3.7 (1.0)

3.6 (1.0)

NRS score for worst LBP inpast 24 h, mean (SD)b

5.6 (2.4)

5.7 (2.0)

6.6 (1.9)

6.2 (2.1)

5.4 (2.4)

5.4 (2.1)

5.9 (2.3)

5.8 (2.1)

Expectation of UMC + CC,mean (SD)e8.2 (1.8)

8.4 (1.6)

8.1 (1.9)

8.3 (1.9)

8.6 (1.8)

8.5 (1.9)

8.3 (1.9)

8.4 (1.8)

Expectation of UMC alone,mean (SD)e5.3 (2.4)

4.9 (2.5)

5.3 (2.3)

5.4 (2.5)

4.5 (2.8)

5.2 (3.0)

5.0 (2.5)

5.2 (2.7)

Race

LBP duration, mo

Abbreviations: BMI, body mass index (calculated as weight in kilograms divided byheight in meters squared); CC, chiropractic care; LBP, low back pain; NRS, Numerical
Rating Scale; NSAIDs, nonsteroidal anti-inflammatory drugs; RMDQ, Roland Morris
Disability Questionnaire; UMC, usual medical care.
a

Walter Reed indicates Walter Reed National Military Medical Center, Bethesda,
Maryland; Pensacola indicates Naval Hospital Pensacola, Pensacola, Florida; and San
Diego indicates Naval Medical Center San Diego, San Diego, California.

bPossible scores range from 0 (no LBP) to 10 (worst possible LBP).

c

Possible scores range from 0 to 24, with higher scores indicating greater disability.

dPossible scores range from 1 (not at all bothersome) to 5 (extremely bothersome).

eIndicates participant’s expectation of helpfulness of treatment for LBP, measured on ascale of 0 (not helpful at all) to 10 (extremely helpful).

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Primary Outcomes
We found significant site × time × group interactions in all models. Adjusted mean differences
between groups overall were consistently in favor of UMC with chiropractic care compared with UMC
alone for the coprimary outcome variables of LBP intensity (mean difference, −1.1; 95% CI, −1.4 to−0.7) and disability (mean difference, −2.2; 95% CI, −3.1 to −1.2) at week 6 (Table 2) as well as at all 3
sites (Figure 2). Findings at week 12 were similar, but with a slightly smaller magnitude of difference(Table 2). Results of the sensitivity analysis showed effects in the same direction with similar
magnitudes and statistical significance under both missing-at-random and missing-not-at-random
approaches for plausible shift parameters of the coprimary outcome variables at all sites. The
possible exception to this was week 6 RMDQ scores at Pensacola, for which a tipping point of 2.33
(mean difference, −1.44; 95% CI, −2.91 to 0.03) was found; however, we considered this to be an
unlikely mean difference between participants with and without missing data. Relative risks (RRs) in
the responder analysis were statistically significantly in favor of greater benefit for the group
receiving UMC with chiropractic care compared with the group receiving UMC alone overall at week
6 (LBP intensity: RR = 1.43; 95% CI, 1.23 to 1.68; disability: RR = 1.35; 95% CI, 1.16 to 1.56) and week 12(LBP intensity: RR = 1.43; 95% CI, 1.23 to 1.68; disability: RR = 1.26; 95% CI, 1.11 to 1.43) and at San
Diego at weeks 6 and 12 but not at Walter Reed at weeks 6 or 12 or at Pensacola at week 12 (Table 3).

Secondary Outcomes
Overall at weeks 6 and 12, participants receiving UMC with chiropractic care, compared with UMC
alone, reported significantly lower mean worst LBP intensity within the past 24 hours (week 6: meandifference, −1.2; 95% CI, −1.6 to −0.8; week 12: mean difference, −1.1; 95% CI, −1.6 to −0.7) andsymptom bothersomeness (week 6: mean difference, −0.4; 95% CI, −0.6 to −0.2; week 12: meandifference, −0.4; 95% CI, −0.6 to −0.2); the differences at each site also were statistically significant,with the exception of bothersomeness at Walter Reed (Table 2). Participants receiving UMC withchiropractic care had significantly better global perceived improvement at 6 weeks at all sites(overall: odds ratio [OR] = 0.18; 95% CI, 0.13 to 0.25; Walter Reed: OR = 0.26; 95% CI, 0.16 to 0.42;
Pensacola: OR = 0.18; 95% CI, 0.10 to 0.33; San Diego: OR = 0.13; 95% CI, 0.08 to 0.21). Similarly,
those receiving UMC with chiropractic care had significantly greater mean satisfaction with care at 6
weeks at all sites (overall: mean difference, 2.5; 95% CI, 2.1 to 2.8; Walter Reed: mean difference,
2.0; 95% CI, 1.4 to 2.6; Pensacola: mean difference, 2.3; 95% CI, 1.6 to 3.0; San Diego: meandifference, 3.1; 95% CI, 2.5 to 3.7). Overall, participants allocated to receive UMC with chiropractic
care self-reported significantly less pain medication use than those receiving UMC alone at week 6(OR = 0.73; 95% CI, 0.54 to 0.97) and week 12 (OR = 0.76; 95% CI, 0.58 to 1.00), but not at any of
the individual sites.

Additional Therapeutic Procedures and UMC
Chiropractic care consisted of several therapeutic procedures in addition to spinal manipulation(eTable 2 in Supplement 2). Use of these therapies varied substantially by site. Participants at Walter
Reed were most likely to receive multiple ancillary therapies across the range of options, while mostin San Diego received therapeutic exercise for strength and flexibility. Usual medical care included
physical therapy referrals and prescription medication, with less variation across sites than that forchiropractic care (eTable 3 in Supplement 2).

Adverse Events
Three unrelated serious adverse events were reported. There were 62 adverse effects reported
throughout the 6-week active care phase: 38 at Walter Reed, 16 at Pensacola, and 8 at San Diego. Of
the 19 adverse effects reported by participants receiving UMC alone, 3 were due to prescribed
medications, 4 were related to epidural injections, and 12 consisted of muscle or joint stiffness
attributed to physical therapy or self-care recommendations. Of the 43 adverse effects reported byparticipants receiving UMC with chiropractic care, 38 were described as muscle or joint stiffness

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3.6
(3.2 to 4.1)

12 wk

7.3
(6.0 to 8.5)

12 wk

2.9
(2.7 to 3.1)

12 wk

4.4
(3.9 to 4.9)

12 wk

3.7
(3.2 to 4.2)

3.9
(3.4 to 4.3)

2.8
(2.6 to 3.0)

2.8
(2.6 to 3.0)

5.8
(4.5 to 7.0)

6.2
(5.0 to 7.4)

3.2
(2.8 to 3.7)

3.2
(2.8 to 3.6)

UMC + CC

2.4
(2.1 to 2.6)

2.7
(2.4 to 2.9)

4.4
(3.0 to 5.8)

5.2
(3.9 to 6.5)

2.8
(2.3 to 3.3)

3.4
(2.9 to 3.9)

−0.8(−1.5 to −0.1)

3.0(2.4 to 3.5)

−0.7
3.4
(−1.3 to −0.02) (2.9 to 3.9)

−0.2(−0.5 to 0.1)

−0.2(−0.5 to 0.1)

−1.5(−3.2 to 0.2)

−1.8(−3.4 to −0.2)−0.4(−1.0 to 0.2)

−0.7(−1.3 to −0.1)

1.4(0.9 to 2.0)

2.1
(1.6 to 2.6)

1.8
(1.6 to 2.1)

2.1
(1.9 to 2.3)

2.5
(1.1 to 3.8)

3.1
(1.8 to 4.4)

1.7
(1.2 to 2.2)

2.2
(1.7 to 2.6)

UMC + CC vsUMC Alone,
Between-Group Within-Group Mean (95% CI)
Difference of
UMC + CC
Means (95% CI) UMC Alone

Pensacolab

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Estimated from mixed-effects models using all observed data, an unstructured covariance, and terms in themodel for time (as a categorical variable), site, and site × group, time × group, and site × time × groupinteractions, adjusted for sex, age, pain duration, and worst pain during the past 24 hours. The Bonferroni
method was used to control for analyzing the coprimary outcome variables. Mean between-group differences
may be off by 0.1 due to rounding.

Abbreviations: CC, chiropractic care; LBP, low back pain; NRS, Numerical Rating Scale; RMDQ, Roland Morris
Disability Questionnaire; UMC, usual medical care.

4.5(4.1 to 5.0)

6 wk

NRS score for worst
LBP in past 24 hc

3.0(2.8 to 3.2)

6 wk

Score ofbothersomeness of
LBPe

Secondary Outcomes

8.0(6.8 to 9.2)

6 wk

RMDQ score fordisabilityd

3.9(3.5 to 4.3)

UMC Alone

Within-Group Mean (95% CI)

6 wk

NRS score foraverage LBP during
past wkc

Primary Outcomes

Outcomes

Walter Reedb

Possible scores range from 0 to 24, with higher scores indicating greater disability.
Possible scores range from 1 (not at all bothersome) to 5 (extremely bothersome).

−1.1(−1.6 to −0.7)−1.2(−1.6 to −0.8)−0.4(−0.6 to −0.2)−0.4(−0.6 to −0.2)−2.0(−3.0 to −1.0)−2.2(−3.1 to −1.2)−0.9(−1.2 to −0.5)−1.1(−1.4 to −0.7)e2.7(2.4 to 3.1)

3.2
(2.9 to 3.5)

2.3
(2.2 to 2.5)

2.6
(2.4 to 2.7)

4.4
(3.6 to 5.2)

5.2
(4.4 to 5.9)

2.6
(2.3 to 2.9)

2.9
(2.6 to 3.2)

Possible scores range from 0 (no LBP) to 10 (worst possible LBP).

3.9(3.5 to 4.2)

4.4
(4.1 to 4.7)

2.7
(2.6 to 2.9)

3.0
(2.8 to 3.1)

6.4
(5.6 to 7.2)

7.3
(6.5 to 8.1)

3.5
(3.2 to 3.8)

4.0
(3.7 to 4.2)

d−1.2(−1.9 to −0.5)−1.6(−2.3 to −1.0)−0.4(−0.7 to −0.1)−0.5(−0.7 to −0.2)−2.7(−4.4 to −1.1)−2.7(−4.3 to −1.1)−1.1(−1.7 to −0.5)−1.3(−1.9 to −0.8)

UMC + CC vsUMC Alone,
Between-Group
Difference ofMeans (95% CI)c

3.2(2.7 to 3.7)

3.6
(3.2 to 4.1)

2.4
(2.2 to 2.6)

2.8
(2.6 to 2.9)

4.8
(3.6 to 6.1)

6.1
(4.9 to 7.3)

2.9
(2.5 to 3.4)

3.3
(2.9 to 3.7)

UMC + CC

Overall
UMC + CC vsUMC Alone,
Between-Group Within-Group Mean (95% CI)
Difference of
UMC + CC
Means (95% CI) UMC Alone

Walter Reed indicates Walter Reed National Military Medical Center, Bethesda, Maryland; Pensacola indicates
Naval Hospital Pensacola, Pensacola, Florida; and San Diego indicates Naval Medical Center San Diego, San
Diego, California.

4.3(3.8 to 4.8)

5.3
(4.8 to 5.7)

2.9
(2.6 to 3.1)

3.2
(3.0 to 3.4)

7.6
(6.3 to 8.8)

8.8
(7.6 to 10.1)

4.0(3.5 to 4.5)

4.6
(4.2 to 5.1)

UMC Alone

Within-Group Mean (95% CI)

San Diegobb−1.5(−2.3 to −0.8)−1.3(−2.0 to −0.7)−0.5(−0.8 to −0.2)−0.5(−0.8 to −0.2)−1.9(−3.7 to −0.2)−2.1(−3.8 to −0.4)−1.1(−1.8 to −0.5)−1.2(−1.8 to −0.6)

UMC + CC vsUMC Alone,
Between-Group
Difference ofMeans (95% CI)

Table 2. Adjusted Within-Group Means and Between-Group Differences of Means in LBP and Disabilitya

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attributed to chiropractic care (37 events) or physical therapy (1 event), 1 was reported as indistinct
symptoms following an epidural injection, 3 were described as pain, tingling, or sensitivity in an
extremity without reference to a specific treatment, and 1 was a lower-extremity burning sensationfor 20 minutes following spinal manipulative therapy.

Discussion
The changes in patient-reported pain intensity and disability as well as satisfaction with care and low
risk of harms favoring UMC with chiropractic care found in this pragmatic clinical trial are consistent
with the existing literature on spinal manipulative therapy in both military23 and civilian20,36-38
populations. The magnitude of mean between-group differences for both pain (NRS) and disability(RMDQ) are consistent with a moderate magnitude of effect as classified by the American College ofPhysicians and American Pain Society guidelines.34,37
This trial has several important strengths. The first is its pragmatic design. The advantages anddisadvantages of a pragmatic clinical trial when evaluating complex treatment approaches have been
well argued.39 These issues were considered by the study team prior to protocol development within
the context that (1) placebo-controlled trials of spinal manipulation exist,40,41 (2) chiropractic care isalready integrated into more than half of military treatment facilities across the United States,42,43
and (3) spinal manipulation or chiropractic care is recommended as a first line of treatment for pain

Figure 2. Adjusted Mean Low Back Pain (LBP) Intensity and Disability Over Time by SiteB

6
5
Usual medical care alone
43

Usual medical care withchiropractic care2
10Baseline 2

4

6

LBP disability, Walter Reed site

Adjusted Mean Roland Morris
Disability Questionnaire Score

Adjusted Mean Average LBPIntensity During Past Week

A LBP intensity, Walter Reed site

12.5
10.0

Usual medical care alone

7.5
5.0

Usual medical care withchiropractic care

2.5
0

12

Baseline 2

Time, wk

Adjusted Mean Roland Morris
Disability Questionnaire Score

5
Usual medical care alone3
2
Usual medical care withchiropractic care

10Baseline 2

4

6

12.5
10.0
7.5

Usual medical care alone

5.0
2.5

Usual medical care withchiropractic care

012Baseline 2

Time, wk

Usual medical care alone

43
Usual medical care withchiropractic care2
10Baseline 2

4

6

6

12

12

LBP disability, San Diego site

Adjusted Mean Roland Morris
Disability Questionnaire Score

F

6
5

4

Time, wk

LBP intensity, San Diego site
Adjusted Mean Average LBPIntensity During Past Week

E

12

D LBP disability, Pensacola site

6

4

6

Time, wk

LBP intensity, Pensacola site
Adjusted Mean Average LBPIntensity During Past Week

C

4

12.5

Usual medical care alone

10.0
7.5
5.0

Usual medical care withchiropractic care

2.50Baseline 2

Time, wk

4

6

12

Time, wk

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Estimated from mixed-effects models using all
observed data, an unstructured covariance, and terms
in the model for time (as a categorical variable), site,and site × group, time × group, andsite × time × group interactions, adjusted for sex, age,pain duration, and worst pain during the past 24 hours.
Low back pain intensity during the prior week wasassessed by the Numerical Rating Scale (scores ranging
from 0 [no LBP] to 10 [worst possible LBP]);
LBP-related functional disability was assessed by the
Roland Morris Disability Questionnaire (scores ranging
from 0-24, with higher scores indicating greater
disability). Walter Reed indicates Walter Reed National
Military Medical Center, Bethesda, Maryland;
Pensacola indicates Naval Hospital Pensacola,
Pensacola, Florida; and San Diego indicates Naval
Medical Center San Diego, San Diego, California.

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37.1
(28.9-47.5)

12 wk

50.4
(41.6-61.0)

12 wk

59.2
(50.2-69.9)

53.7(45.0-64.1)

48.5(39.9-59.0)

49.1(40.5-59.5)

UMC + CC

1.18
(0.92-1.50)

1.23(0.94-1.60)

1.31(0.97-1.78)

1.29(0.96-1.73)

UMC + CC vsUMC Alone, RR(95% CI)

71.7(62.4-82.4)

63.0(53.9-73.6)

52.8(43.4-64.1)

46.1(37.4-56.8)

UMC Alone

79.5(70.5-89.7)

76.6(67.5-86.9)

73.4(63.5-84.8)

69.1(59.3-80.5)

UMC + CC

Within-Group Responders, %Pensacolab

a

b

47.2
(37.6-59.3)

36.6(28.0-47.7)

39.2(30.1-51.1)

19.7(13.2-29.3)

UMC Alone

72.4(62.1-84.4)

59.7(49.9-71.4)

63.5(53.1-75.9)

56.0(46.0-68.2)

UMC + CC

Within-Group Responders, %San Diegob

1.53(1.18-1.99)

1.63(1.20-2.22)

1.62(1.20-2.18)

2.85(1.85-4.38)

UMC + CC vsUMC Alone, RR(95% CI)

55.5(49.4-62.2)

46.6(40.9-53.0)

42.5(36.7-49.2)

32.5(27.3-38.8)

UMC Alone

69.9(63.6-76.7)

62.6(56.6-69.3)

60.9(54.5-68.1)

57.5(51.2-64.6)

UMC + CC

Within-Group Responders, %Overall

1.26(1.11-1.43)

1.35(1.16-1.56)

1.43(1.23-1.68)

1.77(1.46-2.14)

UMC + CC vsUMC Alone, RR(95% CI)

Walter Reed indicates Walter Reed National Military Medical Center, Bethesda, Maryland; Pensacola indicates
Naval Hospital Pensacola, Pensacola, Florida; and San Diego indicates Naval Medical Center San Diego, San
Diego, California.

1.11(0.96-1.28)

1.22(1.03-1.43)

1.39(1.14-1.70)

1.50(1.20-1.88)

UMC + CC vsUMC Alone, RR(95% CI)

Responder is defined as at least 30% improvement from baseline. Estimated from modified Poisson regression
generalized estimating equation models with terms in the model for time (as a categorical variable), group, site,and site × group, time × group, and site × time × group interactions, adjusted for sex, age, pain duration, andworst pain during the past 24 hours.

Abbreviations: CC, chiropractic care; LBP, low back pain; NRS, Numerical Rating Scale; RMDQ, Roland Morris
Disability Questionnaire; RR, relative risk; UMC, usual medical care.

43.8(35.4-54.1)

6 wk

RMDQ for disability

38.0(29.9-48.3)

UMC Alone

6 wk

NRS for average LBP
during past wk

Scale

Within-Group Responders, %Walter Reedb

Table 3. Within-Group Percentage of Responders and Between-Group RRs for Primary Outcomesa

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JAMA Network Open | Physical Medicine and Rehabilitation Effect of Usual Medical Care With vs Without Chiropractic Care for Low Back Pain and Disability
management in military and civilian guidelines.21,22 Furthermore, a pragmatic approach provides theopportunity to better understand the effect of chiropractic care as it is currently integrated anddelivered within military health care settings as part of a multidisciplinary approach.44 This isimportant given the lack of consensus regarding optimal treatment regimens for LBP in general aswell as chiropractic care specifically.
Second, most trials of chiropractic care for LBP have compared it with other monotherapies orusual care. This study focused on understanding the effect of adding chiropractic care to UMC vs
UMC alone, which is consistent with how military health care is provided. Results from this pragmatic
design can directly inform military health care practices and shed light on the potential effect ofchiropractic care in other integrated health care delivery settings, such as patient-centered
medical homes.
Third, this trial included a more diverse sample in terms of race, ethnicity, and age than found inprior studies of either chiropractic or spinal manipulation.25
Fourth, our sample of 750 participants is the largest trial, to our knowledge, evaluating UMC
with chiropractic care vs UMC alone, allowing us to look both across and within 3 military treatment
facilities using standardized outcome measures. By addressing several important limitations, such as
small sample sizes, real-world applicability, and inconsistencies in outcome measures identified inprevious systematic reviews,20,36 our findings further support existing guidelines that recommend
nonpharmacological treatments as a first line of treatment for LBP.22,37 This is a critically important
issue as the US health care delivery system struggles to adequately address the challenges ofmanaging LBP and the opioid epidemic.15,16

Limitations
Although our study findings strengthen the scientific evidence for the use of chiropractic care inpatients with LBP, study limitations leave a number of questions unanswered. Some are inherent to
the nonspecific nature of LBP, the treatment approach used, and trial design. As is true with allstudies of LBP of musculoskeletal origin, the specific diagnosis was difficult to determine or confirm,
contributing toward patient heterogeneity that is not ideally characterized and is thus difficult toaccount for in the analysis. This problem was potentially exacerbated by the use of broad inclusion
criteria, which are characteristic of pragmatic designs to increase the generalizability of study
findings. However, it is difficult to specify the extent to which this heterogeneity contributed topatient outcomes within the context of this trial. Similarly, the use of hands-on, multimodal
interventions commonly delivered by doctors of chiropractic makes it difficult to mask participants
to treatment group or to control for the fact that those with chiropractic care received more time andattention from clinicians. Furthermore, cross-contamination of treatment approaches among andbetween clinicians makes it difficult to specifically identify which component(s) of both UMC andchiropractic interventions were associated with the beneficial effects found in this trial.
Additional limitations specific to the ways in which this particular trial was designed also exist.
Participant visit numbers varied across sites for both UMC and chiropractic care. Although thoseenrolled across all 3 sites were encouraged in a similar manner to seek care based on their treatmentgroup allocation, a larger number of participants in San Diego chose not to access UMC, a discrepancy
that may explain why fewer participants at San Diego who received UMC alone were classified as
respondents at 6 weeks. We attribute these differences in adherence to variations in trial recruitment
strategies. At Walter Reed and Pensacola, most participants were recruited from primary care clinics
by physicians, so they had already chosen to seek medical care for their LBP. The majority ofparticipants at San Diego were recruited using flyers and screened for eligibility by Independent Duty
Corpsmen. We do not know whether these participants chose not to access UMC (1) for logisticalreasons, (2) because UMC had not been beneficial when used previously, or (3) for some other reason
that may have affected their LBP outcomes. These are important considerations for future research.
Differences in participant characteristics, treatments received, and outcomes across sites arealso limitations. The use of standardized outcome measures and inclusion of 250 participants at each

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JAMA Network Open | Physical Medicine and Rehabilitation Effect of Usual Medical Care With vs Without Chiropractic Care for Low Back Pain and Disabilitysite addressed anticipated differences in patient and practice characteristics. However, this strategy
was only partially successful. It is not surprising that Pensacola had the highest proportion of
responders at 6 and 12 weeks for both primary outcomes, as participants here were younger andmore likely to report acute LBP (<1 month). It is less clear why participants at San Diego, most likely
to report chronic LBP (>3 months: >75%) and less likely to seek UMC, showed larger between-groupdifferences in LBP disability at both end points even though they had approximately half thechiropractic visits found at the other 2 sites. Further work is needed to determine the effect ofchiropractic visit numbers on outcomes.
Another challenge, unique to conducting research in the military, was following patients whoare highly transient, especially in times of war. When this study was designed, the active-duty
population of interest was likely to be deployed. Consequently, we chose to follow participants for 12
weeks and excluded those who were scheduled to leave the country within that period. As a result,an additional limitation of this study is the relatively short follow-up.

Conclusions
Chiropractic care, when added to UMC, resulted in moderate short-term treatment benefits in both
LBP intensity and disability, demonstrated a low risk of harms, and led to high patient satisfaction andperceived improvement in active-duty military personnel. This trial provides additional support for
the inclusion of chiropractic care as a component of multidisciplinary health care for LBP, as currently
recommended in existing guidelines.21,22,37 However, study limitations illustrate that further researchis needed to understand longer-term outcomes as well as how patient heterogeneity andintervention variations affect patient responses.

ARTICLE INFORMATION
Accepted for Publication: February 4, 2018.
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Goertz CM
et al. JAMA Network Open.
Corresponding Author: Christine M. Goertz, DC, PhD, Palmer College of Chiropractic, Palmer Center for
Chiropractic Research, 741 Brady St, Davenport, IA 52803 (christine.goertz@palmer.edu).
Author Affiliations: Palmer College of Chiropractic, Palmer Center for Chiropractic Research, Davenport, Iowa
(Goertz, Long, Vining); Parker University Research Institute, Dallas, Texas (Pohlman); Samueli Institute forInformation Biology, Silver Spring, Maryland (Walter); RAND Corporation, Santa Monica, California (Coulter).
Author Contributions: Dr Long had full access to all of the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data analysis.
Concept and design: Goertz, Long, Pohlman, Walter, Coulter.
Acquisition, analysis, or interpretation of data: Goertz, Long, Vining, Pohlman, Walter.
Drafting of the manuscript: Goertz, Long, Vining, Pohlman.
Critical revision of the manuscript for important intellectual content: Long, Vining, Pohlman, Walter, Coulter.
Statistical analysis: Long.
Obtained funding: Goertz, Long, Walter, Coulter.
Administrative, technical, or material support: Goertz, Vining, Pohlman, Walter.
Supervision: Goertz, Long, Vining, Pohlman.
Conflict of Interest Disclosures: Dr Goertz reported receiving personal fees from Spine IQ as chief executive
officer and from the American Chiropractic Association as a consultant outside the submitted work; and owning
stock in Prezacor, Inc. Dr Pohlman reported receiving an educational fellowship from NCMIC Foundation outside
the submitted work. Ms Walter reported receiving grants from RAND Corporation during the conduct of the study;
and receiving grants from the US Army Medical Research Acquisition Agency, Samueli Institute, and RAND
Corporation outside the submitted work. Dr Coulter reported receiving grants from RAND Corporation during the
conduct of the study. No other disclosures were reported.

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Funding/Support: This study was based on work supported by grant W81XWH-11-2-0107 to the RAND
Corporation from the Chiropractic Research Program of the Congressionally Directed Medical Research Programs,
US Army, US Department of Defense.
Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection,
management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; anddecision to submit the manuscript for publication.
Disclaimer: The views expressed are those of the authors and may not reflect the official policy or position of the
US Department of the Army, US Department of Defense, or US government.
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SUPPLEMENT 1.
Trial Protocol
SUPPLEMENT 2.
eTable 1. Primary and Secondary OutcomeseTable 2. Additional Therapeutic Procedures Delivered by Doctors of Chiropractic for Participants in the Usual
Medical Care With Chiropractic Care GroupeTable 3. Types of Usual Medical CareeReferences

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