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Bronfort et al.

Chiropractic & Manual Therapies (2022) 30:10


https://doi.org/10.1186/s12998-022-00419-3

RESEARCH Open Access

Multidisciplinary integrative care


versus chiropractic care for low back pain:
a randomized clinical trial
Gert Bronfort1, Michele Maiers2, Craig Schulz1* , Brent Leininger1, Kristine Westrom1, Greg Angstman3 and
Roni Evans1

Abstract
Background: Low back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however
current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models
with multiple provider types from complementary professional disciplines is one way of integrating therapies to
address patients’ needs more comprehensively.
Methods: This parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate
the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary inte-
grative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary
outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed
work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia meas-
ured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes.
Results: 201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and
were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period
(P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant
advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored
IC by 0.4, but was not statistically significant (95% CI − 0.02 to 0.9; P = 0.06). There was also a significant advantage
over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom
frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-
efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the
interventions.
Conclusions: Participants in the IC group tended to have better outcomes than the CC group, however the magni-
tude of the group differences was relatively small. Given the resources required to successfully implement multidisci-
plinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiroprac-
tic care, for treating LBP.
Trial registration NCT00567333.
Keywords: Back pain, Multidisciplinary, Integrative medicine, Chiropractic, Clinical trial

*Correspondence: [email protected]
1
University of Minnesota, Mayo Building C504, 420 Delaware Street SE,
Minneapolis, MN 55455, USA
Full list of author information is available at the end of the article

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Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 2 of 17

Background Institutional Review Boards at participating institutions


Low back pain (LBP) is one of the most prevalent and dis- (Northwestern Health Sciences University Study #1-32-
abling chronic health conditions. An estimated 40–80% 10-06 and Minneapolis Medical Research Foundation
of adults experience low back pain (LBP) at some point in Study # 07-2785) approved the study protocol which has
their lives [1, 2]. Further, LBP related disability continues been described elsewhere [24]. The study was monitored
to increase, making it a leading cause of disability globally by a Data Safety and Monitoring Board. Written consent
[3]. Approximately 20% of acute cases become chronic was provided by all participants.
[4], and it is these individuals that bear a disproportion-
ate share of LBP associated burden [5]. Importantly, LBP Settings and participants
is one of the stronger risk factors for chronic opioid use The study was conducted at Northwestern Health Sci-
[6]. ences University (Minneapolis, Minnesota). Participants
While the ‘biopsychosocial model’ for LBP has been were recruited from the surrounding Minneapolis/
promoted for decades, it is still incompletely and inade- St. Paul metropolitan area primarily through targeted
quately applied in both research and clinical practice [7– postcard mailings, brochures at community events, and
11]. Indeed, the majority of back pain cases remain poorly advertisements in online local newspapers.
treated with a heavy emphasis on symptom management
[11] using a ‘one size fits all’ approach that fails to address Inclusion criteria
sufferers’ unique needs [7, 11–13]. This has resulted in Inclusion criteria were 18 years of age or older, LBP cat-
the persistent use of marginally effective and potentially egories 1, 2, 3, or 4 according to the Quebec Task Force
harmful unimodal therapies (injections, drug therapies, classification system (individuals with back pain, stiff-
etc.) with a primarily physical focus. Further, current ness, or tenderness with or without leg pain or neurologi-
back pain management practices often contradict clinical cal signs) [25]; current episode of LBP 6 weeks or longer
guideline recommendations by failing to offer treatment in duration; and LBP rating of ≥ 3 on a 0–10 scale during
options with scientific support, including complementary the previous week.
approaches [13–16]. This includes spinal manipulation,
exercise, acupuncture, cognitive behavioral therapy, self- Exclusion criteria
care strategies, and others [15, 17, 18]. Individuals were excluded if they had contraindications
Integrating complementary modalities with conven- to study treatments (i.e. active inflammatory disease of
tional approaches has shown promise for LBP in previous the spine, blood clotting disorders, or severe osteopo-
studies [19]. Team based models of care with multiple rosis) or who were pregnant or nursing, had current or
provider types from complementary professional disci- pending spine-related litigation, a history of multiple
plines has been one way of integrating different therapies lumbar surgeries, or progressive neurological deficits.
to more comprehensively address individual patients’
needs [11, 20]. Such approaches combine a range of Randomization
viable treatment options to synergistically address mul- The study statistician utilized a computer-generated ran-
tidimensional causes of pain, with the goal of exceed- domization scheme and applied a 1:1 allocation ratio
ing the therapeutic effect of any one therapy alone [21, with randomly permuted block sizes that was concealed
22]. A previous manuscript by our group described one from the study team. As individuals became eligible,
approach for a team based model of care including acu- sequentially numbered sealed, opaque envelopes were
puncturists, chiropractors, psychologists, exercise thera- drawn in consecutive order and opened in the presence
pists, massage therapists, primary care physicians with of the study participant by the study team.
case managers coordinating care [23].
The purpose of this manuscript is to report the pri- Interventions
mary and secondary clinical outcomes of a randomized All participants in the study received 12 weeks of either
trial of monodisciplinary chiropractic care (CC), versus monodisciplinary chiropractic care (CC) or multidisci-
multidisciplinary integrative care (IC) for sub-acute and plinary team-based integrative care (IC). CC was deliv-
chronic LBP. ered by a team of chiropractors allowed to utilize any
non-proprietary treatment under their scope of practice
Methods not shown to be ineffective or harmful including manual
This was a parallel group randomized clinical trial spinal manipulation (i.e., high velocity, low amplitude
funded by the US Department of Health and Human Ser- thrust techniques, with or without the assistance of a
vices. It was conducted from May 2007 to October 2009 drop table) and mobilization (i.e., low velocity, low ampli-
with follow-up data collection through August 2010. tude thrust techniques, with or without the assistance of
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 3 of 17

a flexion-distraction table). Chiropractors also used hot Outcomes measures


and cold packs, soft tissue massage, teach and supervise Participant demographic and clinical characteristics
exercise, and administer exercise and self-care education were collected during the baseline visits through self-
materials at their discretion. IC was delivered by a team report questionnaires and a health history and physical
of six different provider types: acupuncturists, chiroprac- examination. Self-reported outcomes were collected at 2
tors, psychologists, exercise therapists, massage thera- baseline visits (7–14 days apart) and at 4, 8, 12, 26, and
pists, and primary care physicians, with case managers 52 weeks after enrollment using questionnaires adminis-
coordinating care delivery. Interventions included acu- tered independent of staff or clinician influence.
puncture and Oriental medicine (AOM), spinal manip-
ulation or mobilization (SMT), cognitive behavioral Primary outcome measure
therapy (CBT), exercise therapy (ET), massage therapy The primary outcome measure was typical level of back
(MT), medication (Med), and self-care education (SCE), pain over the previous week, using a numerical rating
provided either alone or in combination and delivered scale (0 = no pain, 10 = the worst pain possible) [28–31].
by their respective profession. Participants were asked
not to seek any additional treatment for their back pain Secondary outcome measures
during the intervention period. Standardized forms Secondary outcomes included:
were used to document the details of treatment, as well
as adverse events. It was not possible to blind patients • Back disability measured with the 23-item Roland
or providers to treatment due to the nature of the study Morris Disability Questionnaire (converted to a 0 to
interventions. Patients in both groups received individu- 100 scale) [32, 33]
alized care developed by clinical care teams unique to • Global improvement (1 = no symptoms, 100%
each intervention arm. Care team training was conducted improvement; 9 = as bad as it could be, 100% worse)
to develop and support group dynamics and shared clini- [34, 35]
cal decision making. A clinical care pathway, designed • Days with medication use for back pain in the past
to standardize the process of developing recommenda- week [36]
tions, guided team-based practitioner in both interven- • Quality of life measured with the EuroQol EQ5D-3L
tion arms. Evidence based treatment plans were based on (− 0.109 to 1) [37]
patient biopsychosocial profiles derived from the history • Satisfaction with care (1 = completely satisfied,
and clinical examination, as well as baseline patient rated couldn’t be better; 7 = completely dissatisfied,
outcomes. The pathway has been fully described else- couldn’t be worse) [38, 39]
where [23]. Case managers facilitated patient care team • Frequency of low back or leg symptoms (0 = none of
meetings, held weekly for each intervention group, to the time; 5 = all of the time) [32, 40]
discuss enrolled participants and achieve treatment plan • Number of days in the past month with missed work
recommendation consensus. Participants in both inter- or reduced activities due to back pain [41]
vention groups were presented individualized treatment • Work (0 to 42) and physical activity (0 to 24) sub-
plan options generated by the patient care teams, from scales of the fear avoidance beliefs questionnaire [42]
which they could choose based on their preferences. • Pain self-efficacy (0 to 60) [43]
To assess response to treatment during the interven- • Pain coping strategies measured with the Vanderbilt
tion phase, patients completed a Patient Self-Assess- Pain Management Inventory short form (active strat-
ment Form (PSAF) at each of their visits which was egies subscale 5 to 25; passive strategies subscale 6 to
adapted from the Measure Yourself Medical Outcome 30) [44, 45]
Profile [26]. Patients chose a symptom and an activity • Kinesiophobia measured with the Tampa Scale for
most affected by their LBP, and then rated it on a 0–10 Kinesiophobia (17 to 68) [46].
scale. Treating providers monitored patient progress
by assessing patients’ PSAF in relation to benchmarks
for improvement generated from previous studies [23]. Power calculation and sample size
When benchmarks for improvement were not met, In a previous chronic LBP trial of exercise and spinal
providers brought the case back to their respective care manipulation conducted by our team, group differences
team for review and potential alteration of the treat- in pain of up to 8 percentage points after 3 months of
ment plan. treatment were observed. Informed by these results, the
Table 1 describes the specific details of the treatments scientific literature at the time, and consensus of study
using the Template for Intervention Description and investigators and clinicians regarding clinical importance,
Replication (TIDieR) [27]. we were interested in detecting an 8-percentage point
Table 1 Description of interventions using the Template for Intervention Description and Replication (TIDieR) [27]

1. Brief name Monodisciplinary Chiropractic Care (CC) [24] Multidisciplinary Integrative Care (IC) [24]
2.Why Rationale: Chiropractors commonly treat LBP patients with evidence-based Rationale: Given the biopsychosocial nature of LBP, integrating multiple types of
modalities found to be effective for LBP evidence-based modalities may exceed the therapeutic effect of any one modality
alone; one approach is multidisciplinary integrative care
3. What Materials Patients: handouts with pictures and descriptions of exercises and self-care postures
Providers: manuals of operations, standardized treatment notes
4. What Procedures Manual spinal manipulation (i.e., high velocity, low amplitude thrust techniques, Traditional Chinese Medicine (i.e. acupuncture, liquid moxa with a heat lamp, Tui
with or without the assistance of a drop table) Na, and cupping)
Manual mobilization (i.e., low velocity, low amplitude thrust techniques, with or Chiropractic care (including spinal manipulation, manual mobilization, adjunct
without the assistance of a flexion-distraction table) therapies as described in CC group)
Bronfort et al. Chiropractic & Manual Therapies

Spinal mobility, strength/endurance, and stabilization exercises Cognitive behavioral therapy (i.e. operant and respondent cognitive approaches
Adjunct therapies common to clinical practice (i.e. hot and cold packs, soft tissue including environmental restructuring)
massage) Rehabilitative exercise (i.e. spinal mobility, strength/endurance and stabilization
exercises)
Therapeutic massage (i.e. neuromuscular therapy, myofascial techniques, trigger
point therapy, and classic western style Swedish massage)
(2022) 30:10

Medication (i.e. non-steroidal anti-inflammatory drugs (NSAIDS), analgesics, and/or


muscle relaxants)
Self-care education (i.e. spine posture awareness for activities of daily living specific
to their abilities, such as lifting, pushing and pulling, sitting and getting out of bed)
5. Who 3 licensed chiropractors; met weekly as a team 13 licensed or certified practitioners (3 Traditional Chinese Medicine, 2 chiroprac-
Training included review of evidence for specific modalities; collaborative tors, 3 massage therapists, 2 psychologists, 1 allopathic physician, and 2 exercise
evidence-based decision making therapists); met weekly as team
Study related training included orientation to different treatments and practices
(theoretical mechanisms, modalities); review of evidence for specific modalities;
collaborative evidence-based decision making
6. How 1:1 visits; in person
7. Where Research clinic
8. When, how much 12 weeks intervention period; number of visits based on individual patient needs; 12 weeks intervention period; number of visits based on individual patient needs;
typical visit duration 15–30 min typical visit duration varied by treatment type: Cognitive Behavioral Therapy, Mas-
sage Therapy (60 min); Traditional Chinese Medicine, Exercise and Self-Care Educa-
tion (40–60 min); Chiropractic Care (15–30 min); Medication- 15–30 min
9. Tailoring Treatment plan options based on care team’s evaluation of the patient profile generated from baseline health history, physical examination findings, and patient
rated outcomes measures
Treatment plans presented by case manager, and selected by study participant
Decision regarding number and frequency of treatment visits based on patient response to treatment (i.e. self-selected symptom and activity ratings) using a
Patient Self-Assessment Form
10. Modifications None
11. Planned Fidelity Assessment Routine monitoring of standardized treatment notes by research staff
Patient self-report of out-of-scope care during intervention phase
12. Actual Fidelity Assessment 3 patients sought additional care during intervention phase 1 patient sought additional care during intervention phase
Page 4 of 17
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 5 of 17

between group difference in pain after 12 and 52 weeks Secondary analyses of the primary outcome measure
of treatment. Based on an α of 0.05 and 80% power, 85 included group differences at weeks 4, 12, 26, and 52.
participants per group were required. An allowance of Additionally, responder analyses for no pain reduction,
15% drop-out rate resulted in a total sample size of 200 or pain reductions of 30% (minimal improvement), 50%
participants. (moderate improvement), 75%, and 100% (substantial
improvement) were performed at weeks 12, 26, and 52
[53]. Differences in proportions of responders between
Statistical analysis groups were calculated and 95% confidence intervals
We used an intention-to-treat approach, analyzing all were analyzed using the Wilson method for risk differ-
observed data from participants according to their allo- ences [54]. Cumulative responder analysis graphs were
cated treatment assignment. Data were prepared for created to display the proportion of responders for all
analysis by a data manager masked to group status; analy- possible levels of pain reduction [55]. Differences in
ses were performed in SAS, version 9.1. cumulative response curves were assessed by determin-
The primary and most secondary outcomes were ana- ing the area under the response curve using the trapezoi-
lyzed using linear mixed effect models including fixed dal rule and 95% confidence intervals were calculated
effects for time, treatment, and a time-by-treatment using bias-corrected bootstrapping with 5000 iterations
interaction in addition to a random intercept to account [56].
for within-subject correlation. Hierarchical linear mod-
els are a robust method for analyzing ordinal outcomes Secondary outcome measure analysis
using a Likert scale [47]. Secondary outcomes collected Analyses included group differences at the relevant indi-
only at week 12 (i.e. pain management inventory) were vidual time points for all measures, in addition to short-
analyzed using linear regression. Generalized estimating term (including 4 and 12 week outcomes) and long-term
equations were used to analyze missed work and reduced (including all time points) profiles when possible.
activity days. The Binomial family was used to analyze the
proportion of subjects with any missed work or reduced
Results
activity and the Poisson family was used to analyze the
Baseline characteristics
number of missed or reduced days. All models included
A summary of study participants is provided in Fig. 1.
the baseline outcome as a covariate except for analyses of
A total of 384 participants were assessed for eligibility
improvement and satisfaction where baseline measures
and 201 were enrolled. Demographic and baseline clini-
are not applicable.
cal characteristics are provided in Table 2. On average,
participants were just over 50 years of age and had pain
Primary outcome measure analysis that was chronic in nature (8 to 9 years); low back pain
The primary outcomes were short-term (4 to 12 week) intensity was moderate (~ 5 on a 0–10 scale) as was dis-
and long-term (4 to 52 weeks) group differences in pain ability level (~ 40 percent, 0–100). The two groups were
intensity derived from the linear mixed effect model. comparable at baseline in terms of demographic and
We used Fisher’s protected least significant difference clinical characteristics. Pain intensity was the only base-
approach to control for multiplicity [48]. An area under line clinical or demographic characteristic that was mod-
the curve minus baseline summary measure was used erately correlated with changes in pain intensity and was
as the omnibus test to determine if the long-term pain included as a covariate in the primary analysis. Expec-
profile (including 4, 12, 26, and 52 weeks) was different tation of improvement was very weakly correlated with
between groups [49, 50]. The omnibus test needed to change in pain intensity (r = − 0.13 or weaker).
be significant (p-value ≤ 0.05) for group differences in
the short term (weeks 4 through 12) to be determined. Treatment frequency and adherence
Clinical and demographic variables were included as Overall, 96% of study participants attended treatment
covariates if they were at least moderately correlated visits as recommended; 93% for the CC group and 98%
(|r|≥ 0.5) with change in outcomes [51]. Linear mixed in the IC group. The mean number of visits in the CC
effect model analyses provide unbiased estimates when group was 18.1 and for the IC group, was 23.8. Par-
data are missing at random [52]. The pattern and reasons ticipants in the IC group received the following types
for missing data were assessed to determine whether sen- of care: exercise therapy (ET, n = 96); self-care edu-
sitivity analyses to address data missing not at random cation (SCE, n = 59); traditional Chinese medicine
were required. In addition, a sensitivity analysis includ- (TCM, n = 51); massage therapy (MT, n = 37); chiro-
ing patient expectations as a covariate was conducted to practic care (CC, n = 19); cognitive behavioral therapy
assess impact on study results. (CBT, n = 35) and medication (MED, n = 5). The most
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 6 of 17

Fig. 1 CONSORT participant flow

frequent combinations were: TCM/SCE/ET (n = 22); During the 12-week intervention, 4 participants
ET, SCE, MT (n = 10); and ET, SCE, MT, CBT (n = 10). reported visits to other health care providers for their
All participants received at least two types of treat- LBP: 3 from the CC group and 1 from the IC group.
ment, and 27 received at least four. One participant Between weeks 12 and 52, a total of 83 individuals sought
received all of the treatments. additional health care: 46 in CC and 37 in IC.
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 7 of 17

Table 2 Baseline demographics and clinical characteristics (mean (SD) unless otherwise noted)
Parameter Treatment group
Chiropractic Care Integrated Care

n 100 101
Age 52.3 (12.4) 52.6 (12.5)
Female, n (%) 60 (60.0%) 69 (68.3%)
Non-white race, n (%) 5 (5.1%) 1 (1.0%)
Hispanic, n (%) 3 (3.0%) 5 (5.0%)
College degree, n (%) 47 (47.5%) 52 (51.5%)
Household income < $35,000, n (%) 18 (18.3%) 16 (19.8%)
Employed, n (%) 71 (71.0%) 66 (66.0%)
BMI 29.5 (5.8) 27.5 (5.2)
Duration [years] 9.2 (10.1) 8.3 (9.9)
Median [25th to 75th percentiles] 5.0 [2.0 to 15.0] 4.0 [2.0 to 11.0]
Chronic (current episode ≥ 12 weeks), n (%) 97 (97.0%) 98 (97.0%)
Radiation to lower extremity, n (%) 18 (18.0) 21 (20.8)
Back pain associated with trauma
Auto accident, n (%) 5 (5.0%) 4 (4.0%)
Work or leisure time accident, n (%) 21 (21.0%) 21 (20.8%)
Age at first episode of back pain 35.7 (15.0) 35.7 (15.0)
Prior treatment, n (%) 88 (88.0%) 90 (89.1%)
Depression, n (%) 12 (12.0%) 11 (10.9%)
Other pain, n (%) 88 (88.0%) 89 (88.1%)
Tobacco use, n (%) 9 (9.0%) 10 (9.9%)
Low back pain intensity [0 to 10] 5.4 (1.5) 5.1 (1.6)
Low back disability (Roland Morris) [0 to ­100]† 40.9 (21.3) 38.1 (19.2)
Quality of life (EuroQol) [− 0.109 to 1]* 0.76 (0.10) 0.79 (0.06)
Medication use (days/week) 2.8 (2.4) 2.9 (2.4)
Preferred intervention, n (%)
None 19 (19.4%) 17 (17.2%)
Acupuncture and oriental medicine 25 (25.5%) 23 (23.2%)
Chiropractic 19 (19.4%) 17 (17.2%)
Cognitive behavioral therapy 0 (0.0%) 0 (0.0%)
Exercise therapy 11 (11.2%) 11 (11.1%)
Massage 22 (22.4%) 31 (31.3%)
Medication 1 (1.0%) 0 (0.0%)
Self-care education 1 (1.0%) 0 (0.0%)
Expectation of improvement at the end of treatment (1–5) ^ 1.80 (0.53) 1.77 (0.46)

Lower scores indicate lower disability;
*Higher scores indicate higher quality of life;
^Lower scores indicate higher expectations

Effectiveness assessments 12) favored IC by 0.4, but was not statistically signifi-
Primary analysis of primary outcome measure cant (95% CI − 0.02 to 0.9; P = 0.06). Primary results are
The longitudinal omnibus test for pain showed IC to shown in Table 3 and Fig. 2.
be significantly superior to CC over the 1-year period
(P = 0.02). The long-term profile for pain intensity (0–10)
Secondary analysis of primary outcome measure
which included data from weeks 4 through 52, showed
Group differences for pain intensity at individual time
a significant advantage of 0.5 for IC over CC (95% CI
points favored IC and ranged from 0.4 (weeks 4 and
0.1 to 0.9; P = 0.02). The short-term profile (weeks 4 to
12) to 0.6 (week 52), with the only significant finding
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 8 of 17

Table 3 Primary outcome measure—Low back pain intensity


Treatment group Group difference P value*
Chiropractic care Integrated care Chiropractic care minus
integrated care

Low back pain intensity [0 to 10; 0 = no LBP, 10 = the worst LBP possible]
Mean at baseline (SD) 5.4 (1.5) 5.1 (1.6)
Mean at week 4 (95%CI) 4.5 (4.1 to 4.9) 4.0 (3.7 to 4.4) 0.42 (−0.02 to 0.86) 0.07
Mean at week 12 (95%CI) 3.1 (2.7 to 3.4) 2.7 (2.4 to 3.1) 0.37 (−0.12 to 0.85) 0.14
Short term response summary (area 0.41 (−0.02 to 0.85) 0.06
under the curve minus baseline through
week 12)
Mean at week 26 (95%CI) 3.8 (3.4 to 4.2) 3.4 (3 to 3.7) 0.45 (−0.13 to 1.04) 0.13
Mean at week 52 (95%CI) 3.7 (3.3 to 4) 3.0 (2.7 to 3.4) 0.62 (0.04 to 1.21) 0.04
Long term response summary (area 0.46 (0.07 to 0.86) 0.02
under the curve minus baseline through
week 52)
Mean values adjusted for baseline
*Long term response summary serves as the omnibus test p-value. If p > .05, p-values for short term response summary and individual time points are not computed

favored IC over CC, but most differences were not sig-


7
nificant. The exceptions were improvement, satisfaction
6 with care, and frequency of low back symptoms with IC
5 consistently demonstrating a significant advantage over
Pain (0-10)

4
CC. IC also demonstrated a significant advantage over
CC for passive coping strategies at week 12 in addition to
3
disability and self-efficacy at week 52.
2

1 Chiropractic Care Integrated Care


Missing data and sensitivity analyses
0
0 4 12 26 52 Among the 201 participants, 182 (91%) provided data on
Time (weeks) back pain intensity at every time point, and 166 (83%)
Fig. 2 Mean Pain Reduction with 95% Confidence Intervals provided the secondary outcomes at every time point. A
total of 14 participants in the CC group and 5 in the IC
group did not provide primary outcome data at all time
points and the pattern of missingness seemed to be non-
occurring at week 52 (95% CI 0.04 to 1.2; P = 0.04). On random. Participants with missing data at any time point
average, the difference in proportions for reduction of reported higher pain intensity (when data was available)
LBP intensity across all possible thresholds for improve- than participants with no missing data and this pattern
ment favored IC by approximately 6% at 12 weeks (95% was similar between groups. Sensitivity analyses for data
CI − 3 to 13%), 7% at 26 weeks (95% CI − 2 to 15%), and missing not at random were performed using pattern
7% at 52 weeks (95% CI − 2 to 16%). Detailed results mixture methods [57]. Missing pain intensity outcomes
from the responder analyses are provided in Table 4 and were imputed separately for each treatment group using
Figs. 3, 4, 5. multiple imputation (Procedure MI in STATA). Five
imputed data sets were created using a multivariate nor-
mal model including baseline covariates associated with
Analysis of secondary outcome measures missing data. The sensitivity analysis for data missing not
Long term longitudinal profiles significantly favored IC at random assumed the imputed pain intensity outcomes
over CC for disability (Fig. 6), improvement (Fig. 7), satis- were worse by 50%. The estimated group differences from
faction, and low back symptom frequency (Table 5). Med- the missing data sensitivity analyses were similar in mag-
ication use, quality of life, leg symptom frequency, fear nitude and in the same direction as the primary analysis,
avoidance beliefs, and self-efficacy did not significantly and all statistically significant between-group differences
differ between groups over the 1-year period. Cross-sec- remained. The sensitivity analysis adjusting for expec-
tional group differences for secondary outcomes mainly tations led to very small increases of group differences
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 9 of 17

Table 4 Responder analysis


1
Chiropractic care
% Pain reduction Treatment groups Group differences Integrated care

Proportion of responders
.8
Chiropractic Integrated Chiropractic care
Care (%) care (%) minus integrated
care .6

Week 12*
.4
No reduction or 17.7 12.9 4.8 (− 5.3 to 15.1)
increase
.2
≥ 30% 64.6 72.3 −7.7 (−20.3 to 5.2)
  ≥ 50% 50.0 56.4 −6.4 (−19.9 to 7.4)
0
  ≥ 75% 15.6 21.8 −6.2 (−16.9 to 4.9) 0 20 40 60 80 100
100% 1.0 5.9 −4.9 (−11.4 to 0.7) Fig. 4 Percent reduction of LBP intensity at week 26
Week ­26^
No reduction or 26.6 21.6 4.9 (−7.2 to 16.9)
increase
  ≥ 30% 54.3 61.9 −7.6 (−21.1 to 6.3) 1
Chiropractic care
Integrated care
  ≥ 50% 28.7 43.3 −14.6 (−27.4 to

Proportion of responders
−1.0) .8
≥ 75% 14.9 18.6 −3.7 (−14.3 to 7.1)
100% 2.1 3.1 −1.0 (−6.8 to 4.7) .6

Week ­52†
.4
No reduction or 25.3 16.5 8.8 (−2.9 to 20.5)
increase
  ≥ 30% 50.6 64.9 −14.4 (−27.9 to .2
−0.1)
  ≥ 50% 36.8 48.5 −11.7 (−25.2 to 2.6) 0
  ≥ 75% 19.5 21.6 −2.1 (−13.6 to 9.7) 0 20 40 60 80 100

100% 3.4 5.2 −1.7 (−8.4 to 5.2) Fig. 5 Percent reduction of LBP intensity at week 52

Proportion of participants with at least 30, 50, 75, or 100% reduction in pain
intensity
*Analysis included 96 participants in Chiropractic care group and 101 in
Integrated care group;
^ 50
Analysis included 94 participants in Chiropractic care group and 97 in
Integrated care group;
† 40
Analysis included 87 participants in Chiropractic care group and 97 in
Disability (0-100)

Integrated care group;


30

20

10
Chiropractic Care Integrated Care

0
0 4 12 26 52
1 Time (weeks)
Chiropractic care
Integrated care Fig. 6 Mean disability reduction with 95% confidence intervals
Proportion of responders

.8

.6
ranging from 0.3 to 1.1 percentage points across all time
points.
.4

.2 Adverse events
There were five serious adverse events (SAEs) that
0
occurred during the course of the trial (CC = 4, IC = 1);
0 20 40 60 80 100
all were classified as unrelated to study interventions.
Fig. 3 Percent reduction of LBP intensity at week 12
Four SAEs were reported by patients assigned to CC
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 10 of 17

group difference fell below the threshold of a moder-


9
ate effect size that was used to power the study. Further,
despite the IC group consistently reporting greater per-
7
centage reductions of pain intensity than the CC group,
Improvement (1-9)

they were generally small (< 10%) with the exception of


5 the 50% threshold at Week 26 and the 30% threshold at
Week 52. There was a significant advantage over the long
3 term for IC in terms of some secondary measures (dis-
Chiropractic Care Integrated Care ability, improvement, satisfaction and low back symptom
frequency), but not for others (medication use, quality of
1
0 4 12 26 52 life, leg symptom frequency, fear avoidance beliefs, self-
Time (weeks) efficacy, active pain coping, and kinesiophobia). Impor-
Fig. 7 Mean improvement with 95% confidence intervals tantly, no serious adverse events resulted from either of
the interventions, and less serious events were approxi-
mately equal in both groups. Functional change in objec-
tive measures of torso strength and endurance, as well
in which three were hospitalized (pneumonia, surgical as lumbar dynamic motion characteristics, may provide
intervention for fractured foot, and syncope), and one further clinical implications and it is our intent to ana-
diagnosed with a brain tumor. One patient assigned to lyze and report these outcomes in future manuscripts.
IC was hospitalized for nephrolithiasis evaluation and Similarly, qualitative analysis of interviews collected pre
management. and post study invention will give insight to the patients’
Minor self-limiting adverse events during the 12 weeks perspective. Finally, while a formal cost-effectiveness
of intervention were reported with about equal fre- analysis has yet to be performed, the IC group did require
quency in both groups (Table 6). The most commonly substantially more resources to implement, and patients
reported participants were unusual or increased soreness in that group had more visits raising the question of
(51–54%) and a different type of pain (31–34%). cost–benefit. When considered together, these factors
suggest that while the IC group tended to do better in the
Discussion long term on some important outcomes, the overall clini-
Summary of findings cal importance of these findings remains debatable for
While there have long been calls to address LBP from a chronic LBP populations similar to the one studied.
more comprehensive biopsychosocial perspective, there
is still little research to date that has done so in a rigorous Comparison with other studies
fashion. This study examines one approach for remedying The most recent Cochrane systematic review by Kamper
this gap by comparing an integrative care (IC) interven- et al. [20] examining multidisciplinary biopsychosocial
tion applying a multidisciplinary team-based approach rehabilitation programs for chronic LBP found a modest
to monodisciplinary chiropractic care. Overall, analyses advantage compared to usual care or physical treatments
demonstrated a consistent trend in favor of the IC group. for reducing pain and disability and increasing the likeli-
hood of return to work. We have identified 6 additional
Clinical importance trials published after the Cochrane review which had
Discussions of clinical importance for group differences similar magnitudes of improvement in pain intensity and
requires consideration of the broader context regard- disability relative to physical treatments, generally con-
ing the condition being studied, what treatments are firming our findings [59–65]. Two low risk of bias trials
available, and the overall risk–benefit ratio of available conducted by Monticone et al. are notable exceptions [59,
options, which goes beyond criteria for establishing a 60]. These trials reported much larger treatment effects
clinically important change at the individual patient level for a multidisciplinary program incorporating CBT with
[58]. Several factors should be considered when assessing manual treatment and task-oriented exercise compared
the clinical importance of study results including magni- to manual therapy and exercise, with average reductions
tude of group differences in primary and secondary out- in pain intensity and disability around 50–75%.
comes, proportion of responders, consistency of findings The Kamper et al. review reported on subgroup analy-
across outcomes, durability of effects, adverse events, ses assessing the impact of baseline symptom severity on
treatment adherence, and costs [58]. While there was an the effectiveness of the multidisciplinary programs and
advantage for the IC group in terms of the primary out- found the results were inconclusive; however, given the
come, pain intensity over 1 year, the magnitude of the modest benefits and relatively high resource and cost
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 11 of 17

Table 5 Participant-reported secondary outcome measures


Treatment group Group difference P value*
Chiropractic care Integrated care Chiropractic care
minus integrated care

Low back disability (Roland Morris) [0 to 100; lower scores indicate less disability]
Mean at baseline (SD) 40.9 (21.3) 38.1 (19.2)
Mean at week 4 (95% CI) 30.3 (27 to 33.6) 27.0 (23.7 to 30.2) 3.07 (− 0.95 to 7.08) 0.14
Mean at week 12 (95% CI) 19.9 (16.6 to 23.2) 16.5 (13.3 to 19.7) 3.66 (− 0.65 to 7.97) 0.10
Short term response summary (area under the curve minus baseline 3.36 (− 0.65 to 7.38) 0.10
through week 12)
Mean at week 26 (95% CI) 24.6 (21.2 to 27.9) 20.2 (16.9 to 23.4) 4.05 (− 0.97 to 9.07) 0.12
Mean at week 52 (95% CI) 25.6 (22.1 to 29) 19.0 (15.7 to 22.3) 6.54 (1.18 to 11.90) 0.02
Long term response summary (area under the curve minus baseline 4.62 (0.88 to 8.36) 0.02
through week 52)
Improvement [1 to 9; 1 = 100% Improvement, 9 = 100% Worse]
Mean at week 4 (95% CI) 3.9 (3.6 to 4.1) 3.6 (3.3 to 3.8) 0.31 (0.03, 0.60) 0.03
Mean at week 12 (95% CI) 3.1 (2.9 to 3.4) 2.8 (2.6 to 3.1) 0.29 (− 0.04, 0.63) 0.09
Short term response summary 0.31 (0.01 to 0.61) 0.04
(Area under the curve through week 12)
Mean at week 26 (95% CI) 3.5 (3.2 to 3.8) 3.1 (2.8 to 3.3) 0.38 (0.08, 0.68) 0.01
Mean at week 52 (95% CI) 3.6 (3.3 to 3.9) 3.1 (2.8 to 3.3) 0.37 (0.08, 0.65) 0.01
Long term response summary (area under the curve through week 52) 0.41 (0.14 to 0.68) < 0.01
Medication use [days/week]
Mean at baseline (SD) 2.8 (2.4) 2.9 (2.4)
Mean at week 4 (95% CI) 2.3 (1.9 to 2.7) 2.6 (2.2 to 3) − 0.27 (− 0.77 to 0.24)
Mean at week 12 (95% CI) 1.8 (1.4 to 2.2) 1.8 (1.4 to 2.2) − 0.05 (− 0.63 to 0.52)
Short term response summary (area under the curve minus baseline − 0.21 (− 0.71 to 0.30)
through week 12)
Mean at week 26 (95% CI) 1.8 (1.4 to 2.2) 2.2 (1.8 to 2.6) − 0.44 (− 1.06 to 0.19)
Mean at week 52 (95% CI) 2.3 (1.9 to 2.8) 1.9 (1.5 to 2.4) 0.50 (− 0.17 to 1.17)
Long term response summary (area under the curve minus baseline − 0.11 (− 0.58 to 0.36) 0.65
through week 52)
Quality of life (EuroQol) [− 0.109 to 1; higher scores indicate better quality of life]
Mean at baseline (SD) 0.76 (0.10) 0.79 (0.06)
Mean at week 4 (95% CI) 0.80(0.78 to 0.82) 0.81 (0.79 to 0.83) − 0.01 (− 0.04 to 0.02)
Mean at week 12 (95% CI) 0.83 (0.81 to 0.85) 0.85 (0.83 to 0.87) − 0.02 (− 0.05 to 0.01)
Short term response summary (area under the curve minus baseline − 0.01 (− 0.04 to 0.01)
through week 12)
Mean at week 26 (95% CI) 0.81 (0.79 to 0.83) 0.82 (0.80 to 0.84) − 0.02 (− 0.04 to 0.01)
Mean at week 52 (95% CI) 0.82 (0.79 to 0.84) 0.84 (0.82 to 0.86) − 0.02 (− 0.05 to 0.004)
Long term response summary (area under the curve minus baseline − 0.02 (− 0.04 to 0.003) 0.09
through week 52)
Satisfaction with care [1 to 7; 1 = Completely Satisfied, 7 = Completely Dissatisfied]
Mean at week 4 (95% CI) 2.1 (1.9 to 2.3) 1.8 (1.6 to 2) 0.34 (0.12, 0.57) < 0.01
Mean at week 12 (95% CI) 2 (1.8 to 2.2) 1.7 (1.5 to 1.9) 0.33 (0.09, 0.56) < 0.01
Short term response summary (area under the curve minus baseline 0.34 (0.11 to 0.56) < 0.01
through week 12)
Mean at week 26 (95% CI) 2.3 (2.1 to 2.5) 1.9 (1.7 to 2.1) 0.38 (0.08, 0.68) 0.01
Mean at week 52 (95% CI) 2.2 (2 to 2.4) 1.8 (1.6 to 2) 0.37 (0.08, 0.65) 0.01
Long term response summary (area under the curve through week 52) 0.38 (0.16 to 0.59) < 0.01
Low back symptom frequency [0 to 5; 0 = none of the time, 5 = all of the time]
Mean at baseline (SD)
Mean at week 4 (95% CI) 3.11 (2.9 to 3.32) 2.83 (2.62 to 3.04) 0.28 (− 0.01 to 0.58) 0.06
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 12 of 17

Table 5 (continued)
Treatment group Group difference P value*
Chiropractic care Integrated care Chiropractic care
minus integrated care

Mean at week 12 (95% CI) 2.38 (2.17 to 2.59) 2.02 (1.81 to 2.23) 0.36 (0.06 to 0.66) 0.02
Short term response summary 0.31 (0.07 to 0.56) 0.01
(Area under the curve minus baseline through week 12)
Mean at week 26 (95% CI) 2.68 (2.47 to 2.9) 2.33 (2.12 to 2.54) 0.35 (0.05 to 0.66) 0.02
Mean at week 52 (95% CI) 2.41 (2.19 to 2.64) 1.95 (1.74 to 2.16) 0.46 (0.16 to 0.77) 0.003
Long term response summary (area under the curve through week 52) 0.38 (0.15 to 0.60) 0.001
Leg symptom frequency [0 to 5; 0 = none of the time, 5 = all of the time]
Mean at baseline (SD)
Mean at week 4 (95% CI) 1.1 (0.92 to 1.28) 1.03 (0.85 to 1.21) 0.07 (− 0.19 to 0.32)
Mean at week 12 (95% CI) 0.77 (0.58 to 0.95) 0.66 (0.49 to 0.84) 0.1 (− 0.15 to 0.36)
Short term response summary 0.08 (− 0.13 to 0.29)
(Area under the curve minus baseline through week 12)
Mean at week 26 (95% CI) 0.94 (0.75 to 1.12) 0.87 (0.69 to 1.05) 0.07 (− 0.2 to 0.33)
Mean at week 52 (95% CI) 1.04 (0.85 to 1.24) 0.79 (0.6 to 0.97) 0.26 (− 0.01 to 0.52)
Long term response summary 0.12 (− 0.06 to 0.31) 0.19
(Area under the curve through week52)
Any missed work days due to back problem in past month [%]
Percentage at baseline (n) 36.3 (36) 36.6 (37)
Percentage at week 4 (95% CI) 23.5 (16.4 to 30.5) 24.2 (17.4 to 31.0) − 0.7 (− 10.2 to 8.7)
Percentage at week 12 (95% CI) 17.5 (11.0 to 24.1) 13.0 (8.2 to 17.8) 4.5 (− 3.1 to 12.1)
Percentage at week 26 (95% CI) 15.2 (9.4 to 21.1) 16.6 (10.6 to 22.6) − 1.3 (− 9.1 to 6.5)
Percentage at week 52 (95% CI) 17.3 (10.5 to 24.1) 16.1 (9.9 to 22.3) 1.2 (− 7.6 to 10.0)
Number of missed work days due to back problem in past month [0–31 days]
Mean at baseline (SD) 6.0 (4.9) 6.6 (6.8)
Mean at week 4 (95% CI) 6.09 (3.56 to 8.62) 4.49 (3.13 to 5.85) 1.60 (− 1.29 to 4.49)
Mean at week 12 (95% CI) 2.18 (1.35 to 3.01) 3.84 (1.55 to 6.12) − 1.65 (− 4.12 to 0.81)
Mean at week 26 (95% CI) 6.23 (1.33 to 11.14) 5.38 (0.54 to 10.21) 0.86 (− 6.07 to 7.78)
Mean at week 52 (95% CI) 3.16 (1.98 to 4.33) 6.11 (0.20 to 12.02) − 2.96 (− 9.03 to 3.11)
Any reduced activity days due to back problem in past month [%]
Percentage at baseline (n) 74.0 (74) 72.2 (73)
Percentage at week 4 (95% CI) 54.4 (45.7 to 63.1) 64.8 (56.5 to 73.1) − 10.4 (− 22.4 to 1.6)
Percentage at week 12 (95% CI) 41.3 (31.4 to 51.2) 41.8 (32.9 to 50.8) − 0.6 (− 13.9 to 12.8)
Percentage at week 26 (95% CI) 43.7 (34.7 to 52.7) 37.1 (30.0 to 44.2) 6.6 (− 4.4 to 17.6)
Percentage at week 52 (95% CI) 41.5 (32.6 to 50.4) 34.7 (26.9 to 42.5) 6.8 (− 4.5 to 18.2)
Number of reduced activity days due to back problem in past month [0–31 days]
Mean at baseline (SD) 9.0 (8.2) 8.4 (8.0)
Mean at week 4 (95% CI) 6.05 (5.02 to 7.08) 5.07 (4.19 to 5.95) 0.98 (− 0.26 to 3.01)
Mean at week 12 (95% CI) 5.04 (3.10 to 6.99) 4.22 (3.10 to 5.35) 0.82 (− 1.37 to 3.01)
Mean at week 26 (95% CI) 4.58 (3.56 to 5.60) 4.53 (3.55 to 5.51) 0.05 (− 1.24 to 1.33)
Mean at week 52 (95% CI) 4.84 (3.36 to 6.33) 4.53 (3.54 to 5.52) 0.31 (− 1.34 to 1.96)
Fear avoidance beliefs—work subscale [0–42; higher scores indicate greater fear avoidance beliefs]
Mean at baseline (SD) 9.13 (8.94) 9.69 (8.47)
Mean at week 4 (95% CI) 8.30 (7.15 to 9.45) 7.53 (6.4 to 8.66) 0.77 (− 0.84 to 2.38)
Mean at week 12 (95% CI) 7.10 (5.94 to 8.26) 5.94 (4.82 to 7.06) 1.16 (− 0.45 to 2.77)
Short term response summary (area under the curve minus baseline 0.93 (− 0.46 to 2.31)
through week 12)
Mean at week 26 (95% CI) 6.80 (5.62 to 7.98) 5.65 (4.51 to 6.78) 1.15 (− 0.48 to 2.79)
Mean at week 52 (95% CI) 6.60 (5.39 to 7.81) 6.49 (5.34 to 7.64) 0.11 (− 1.56 to 1.78)
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 13 of 17

Table 5 (continued)
Treatment group Group difference P value*
Chiropractic care Integrated care Chiropractic care
minus integrated care

Long term response summary (area under the curve through week 52) 0.84 (− 0.44 to 2.11) 0.20
Fear avoidance beliefs—physical activity subscale [0 to 24; higher scores indicate greater fear avoidance beliefs]
Mean at baseline (SD) 11.66 (5.42) 11.63 (5.32)
Mean at week 4 (95% CI) 9.03 (8.04 to 10.01) 9.3 (8.33 to 10.27) − 0.28 (− 1.66 to 1.11)
Mean at week 12 (95% CI) 7.54 (6.55 to 8.54) 7.36 (6.39 to 8.33) 0.18 (− 1.21 to 1.57)
Short term response summary − 0.09 (− 1.31 to 1.12)
(Area under the curve minus baseline through week 12)
Mean at week 26 (95% CI) 7.71 (6.7 to 8.72) 6.52 (5.53 to 7.5) 1.20 (− 0.21 to 2.6)
Mean at week 52 (95% CI) 7.61 (6.57 to 8.64) 7.22 (6.23 to 8.21) 0.39 (− 1.04 to 1.82)
Long term response summary (area under the curve through week 52) 0.59 (− 0.55 to 1.72) 0.31
Self-efficacy [0 to 60; higher scores indicate greater self-efficacy]
Mean at baseline (SD) 48.0 (10.0) 49.2 (8.7)
Mean at week 4 (95% CI) 52.2 (50.9 to 53.6) 52 (50.7 to 53.4) 0.18 (− 1.70 to 2.07)
Mean at week 12 (95% CI) 54.4 (53 to 55.7) 54.7 (53.4 to 56) − 0.33 (− 2.22 to 1.57)
Short term response summary (area under the curve minus baseline − 0.02 (− 1.67 to 1.63)
through week 12)
Mean at week 26 (95% CI) 52.5 (51.2 to 53.9) 53.2 (51.8 to 54.5) − 0.63 (− 2.55 to 1.29)
Mean at week 52 (95% CI) 51.8 (50.4 to 53.2) 53.8 (52.5 to 55.2) − 1.99 (− 3.94 to − 0.04)
Long term response summary (area under the curve through week 52) − 0.82 (− 2.35 to 0.71) 0.29
Active pain coping strategies (pain management inventory) [5 to 25; higher scores indicate more frequent use]
Mean at baseline (SD) 17.3 (3.4) 17.1 (3.6)
Mean at week 12 (95% CI) 18.2 (17.6 to 18.9) 19.0 (18.4 to 19.7) − 0.8 (− 1.7 to 0.1) 0.07
Passive pain coping strategies (Pain Management Inventory) [6 to 30; higher scores indicate more frequent use]
Mean at baseline (SD) 13.8 (4.5) 13.9 (3.9)
Mean at week 12 (95% CI) 12.6 (12.0 to 13.2) 11.7 (11.1 to 12.3) 0.9 (0.1 to 1.7) 0.036
Kinesiophobia [17 to 68] (11 questions; 1 = Strongly Disagree—4 = Strongly Agree)
Mean at baseline (SD) 35.2 (6.3) 33.2 (5.8)
Mean at week 12 (95% CI) 29.7 (28.6 to 30.8) 28.7 (27.6 to 29.8) 1.0 (2.6 to − 0.6) 0.20
Mean values adjusted for baseline except for improvement and satisfaction
*Long term response summary serves as the omnibus test p-value. If p > .05, p-values for short term response and individualtime points are not computed

burden, the authors suggest these programs be reserved application of a clinical care pathway that integrated
for the most severe cases where marked psychosocial dis- the best available evidence with patient-rated outcome
tress is present. This approach is consistent with emerg- instruments and patient preferences to create biopsycho-
ing risk-stratification and stepped care models aimed social patient profiles to inform team based shared deci-
towards improving the efficiency and quality of care for sion making [23].
musculoskeletal conditions [66]. As with any study there are also limitations that must
be considered when interpreting the results. An impor-
Strengths and limitations tant one which is common to many studies of com-
This study had several strengths, including the long- plementary therapies, is the lack of representation of
term follow up and high intervention adherence and fol- individuals from more diverse backgrounds, especially in
low up data collection rates. Expectations, a potentially terms of race and income. Also, despite careful attention
important contextual factor that can influence treatment to applying a clinical care pathway process [23], it was
outcomes [67, 68] were measured, and were found to not validity and reliability tested, limiting its replication
be similar between groups and had little impact on the to other research and clinical settings, and potentially
primary outcome. Importantly, side effects and adverse impacting the results of this trial. For example, while an
events were systematically collected and reported (see important aspect of the pain pathway included assess-
Table 6). Another strength was the development and ing patients’ psychosocial needs with established patient
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 14 of 17

Table 6 Adverse events during the 12-week treatment*


Treatment group Group difference

Chiropractic care Integrated care Chiropractic care minus


Integrated care (95% CI)
n† Median n† Median
(%) bothersomeness ^ (%) bothersomeness ^

Different type of pain 33 (33.7%) 6 35 (34.7%) 5 − 1.0 (− 13.9 to 12.0)


Increased back pain intensity 20 (20.4%) 5 23 (22.8%) 5 − 2.4 (− 13.7 to 9.1)
New or increased leg pain, numbness, 16 (16.3%) 4 13 (12.9%) 2 3.5 (− 6.5 to 13.5)
or weakness
Unusual or increased soreness 41 3 47 3 − 4.7 (− 18.1 to 9.0)
(41.8%) (46.5%)
Skin irritation 4 7 5 (5.0%) 2 − 0.9 (− 7.5 to 5.7)
(4.1%)
More fatigue than usual 14 5 13 (12.9%) 4 1.4 (− 8.3 to 11.2)
(14.3%)
Dizziness or lightheadedness 11 4 12 (11.9%) 3 − 0.7 (− 9.8 to 8.6)
(11.2%)
Upset stomach, nausea, or vomiting 6 4 5 (5.0%) 2 1.2 (− 5.8 to 8.3)
(6.1%)
Changes in bowel or bladder habits 4 1 13 (12.9%) 0.5 − 8.8 (− 17.1 to − 0.9)
(4.1%)
*Analysis included 98 participants in Chiropractic care group and 101 in Integrated care group;

Participants reporting at least one event during treatment, participants could report more than one event
^Bothersomeness on 0–10 scale; bothersomeness was averaged for participants with more than one of the same event during the 12 weeks of treatment

rated outcome instruments, treatment plans were still from completion of the trial to publishing of the results,
very much oriented towards managing pain, versus the which came about from several members of the investi-
whole person with pain, which is advocated for a truly gative team changing institutions. The findings however
biopsychosocial approach [11]. This was evidenced by remain very relevant especially in light of continued and
providers recommending and patients mainly choos- pervasive use of biophysically focused mono-discipli-
ing treatments that were focused on physical symptoms nary treatments (e.g. medications, surgery, etc.) that still
and function in the IC group [23]. Of note is that social plague the LBP field, despite their limited effectiveness.
factors were not thoroughly addressed which is a com-
mon limitation of current pain research and should be Implication for clinical practice
remedied in future trials [11]. Admittedly, assessing psy- Team based models of care with multiple provider types
chosocial risk is still an area in the LBP field that remains from complementary disciplines has been one way of
relatively underdeveloped [69, 70]. Patients in this study integrating different therapies to more comprehen-
had relatively low baseline measures of fear-avoidance sively address patients’ needs [11, 20]. However, these
beliefs, and high self-efficacy and active pain coping approaches can have significant challenges includ-
which all would suggest these patients to be only mod- ing inconvenience and inaccessibility due to multiple
estly psychosocially impacted, and which potentially appointments with different providers along with sub-
explains the lack of use of CBT in this study. stantial system resources needed to coordinate care
Because of the pragmatic nature of the study with inter- across provider types, all which can contribute to dis-
vention delivery designed to approximate how it could be jointed and unsatisfactory care [11]. While our study
implemented in practice, it is difficult to discern between was able to successfully coordinate multidisciplinary
the active elements of treatment and potentially impor- treatment plans for participants as evidenced by high
tant contextual and structural intervention qualities (e.g. adherence and satisfaction rates, achieving this required
influence of the practitioner, therapeutic relationship, significant time and resources which is a major barrier in
number of visits, time spent, etc.). Additionally, fidelity most clinical settings [11, 23]. Further, the findings of this
assessments of the interventions were limited to docu- trial, along with other research evidence, suggest only
mentation by providers and patient-self report. Finally, modest advantages in terms of clinical outcomes of mul-
another limitation of the study is the time it has taken tidisciplinary team based interventions [20]. Importantly,
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 15 of 17

the IC group in this study had a mean of nearly 24 vis- care for low back pain should be explored with greater
its compared to 18 in the CC group, with many of the emphasis on addressing the full spectrum of related
visit lengths substantially longer than a typical CC visit. psychosocial mechanisms and ensuring equitable
This has potential cost implications to both systems and access for all.
patients, posing additional hurdles to effective pain care,
Acknowledgements
especially for those with challenging socioeconomic cir- The authors acknowledge the contributions of our independent statistical
cumstances. It is likely that offering these resource inten- analysis team, dedicated project managers, research clinicians and staff, sup-
sive approaches are not going to be cost-effective. As one porting institution (Northwestern Health Sciences University).
example, cost-effectiveness comparisons of chiropractic Authors’ contributions
care have been shown to be more advantageous to more CS participated in the design, development and implementation of the study
structurally intensive interventions for older neck pain procedures including participating as a provider in the IC group. He took
primary responsibility for the preparation and submission of the manuscript
patients [71]. including synthesizing information related to intervention delivery and patient
participation ensuring complete reporting in accordance with CONSORT and
TIDieR. RE participated in the design of the study and in securing funding;
Implication for future research she was a major contributor to the preparation of this manuscript, including
One potential alternative to integrative multidisciplinary the accurate reporting and interpretation of study results. She was the person
interventions is to train individual front-line providers to primarily responsible for the preparation of the background and discussion
sections. BL participated in data analysis, interpretation of results, drafting of
address patients’ biopsychosocial needs within the scope the article, and critical revision for important intellectual content, particularly
of their professional discipline, using multiple modalities the background and discussion sections. MM was a major contributor to
to support guideline recommendations. Indeed, there the design of the study and funding acquisition; she oversaw project and
case manager activities to ensure adherence with protocols and the study’s
have been shifts in both the chiropractic and physical successful implementation. GB was the person primarily responsible for the
therapy fields to take such an approach, integrating more scientific design of the study and funding acquisition, and for ensuring the
psychosocial elements to these professional care mod- study was executed with scientific rigor. He worked with the statisticians to
implement the pre-planned statistical analysis and played a major role in the
els [72–75]. To facilitate, future attention is required to interpretation of study results. GA trained the multidisciplinary Integrated Care
developing translational support tools to comprehen- teams in teamwork and group decision making. He participated in designing
sively address the full range of patients’ biopsychosocial the training for the IC care teams and delivered the training to the IC Team
members teaching them consensus decision making techniques. KW partici-
needs in a manner that facilitates shared decision making pated in the design and implementation of the study. She was a provider in
and monitoring in an accurate, systematic and practical the IC group and assisted in oversight of project and case manager activities.
manner [66, 76]. All authors have read and approved the final manuscript.
Additionally, future studies should consider ‘interven- Funding
tion mapping’ in the trial design phase, where the mech- Research reported in this publication was supported by the Department of
anisms of action of each element of multimodal care Health and Human Services (HHS), Health Resources and Services Administra-
tion (HRSA), Bureau of Health Professions (BHPr), Division of Medicine and
packages are more carefully aligned with patient needs Dentistry (DMD) under award number R18HP07639. Efforts of Dr. Leininger
and perhaps a greater range of more relevant psychoso- and Dr. Schulz were also supported in part by the National Center For Comple-
cial outcomes. This can facilitate results interpretations, mentary & Integrative Health of the National Institutes of Health (NIH) under
Award Number K01AT008965 and KL2TR002492-02S1. The content is solely
as well as reporting and replication of interventions, and the responsibility of the authors and does not necessarily represent the official
ultimately broader dissemination to those who could views of HHS, HRSA, BHPr, DMD or the NIH.
most benefit [77, 78]. Greater attention should also be
Availability of data and materials
given to fidelity assessment (i.e. video recordings) to The data analyzed during the current study are available from the correspond-
ensure interventions are being delivered as intended. ing author on reasonable request.
Finally, given the resource intensive nature of the IC
group, cost-effectiveness analyses comparing CC to IC Declarations
from societal and healthcare perspectives are warranted;
Ethics approval and consent to participate
these are forthcoming in a future publication. Ethical approval for the study was provided by the Institutional Review Boards
at Northwestern Health Sciences University #1-32-10-06 and the Minneapolis
Medical Research Foundation # 07-2785. All participants provided written
Conclusion informed consent to participate.
Low back pain patients who received integrative care by
a multidisciplinary integrative care team tended to have Consent for publication
Not applicable.
better outcomes than those who received chiropractic
care. However, given the relatively small magnitude of Competing interests
between group differences and the extensive resources The authors declare that they have no competing interests.
required to successfully manage and implement, the Author details
team based integrative care might not be worthwhile. 1
University of Minnesota, Mayo Building C504, 420 Delaware Street SE, Min-
More efficient models for addressing biopyschosocial neapolis, MN 55455, USA. 2 Northwestern Health Sciences University, 2501 W.
Bronfort et al. Chiropractic & Manual Therapies (2022) 30:10 Page 16 of 17

84th Street, Bloomington, MN 55431, USA. 3 St. Elizabeth’s Medical Center- 20. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman
Wabasha, 1000 1st Dr NW, Austin, MN, USA. J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for
chronic low back pain. Cochrane Database Syst Rev 2014, 9:CD000963.
Received: 30 September 2021 Accepted: 11 February 2022 21. Parkin-Smith GF, Amorin-Woods LG, Davies SJ, Losco BE, Adams J. Spinal
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2015;8:741–52.
22. Wayne PM, Eisenberg DM, Osypiuk K, Gow BJ, Witt CM, Davis RB, Buring
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