Spine (Phila Pa 1976). 2013 (Nov 15); 38 (24): 2071–2078 ~ FULL TEXT
Bruce F. Walker, DC, MPH, DrPH, Jeff J. Hebert, DC, PhD, Norman J. Stomski, PhD, Barrett Losco, MChiropractic, and Simon D. French, PhD
School of Health Professions
School of Psychology and Exercise Science,
Murdoch, Australia; and
School of Rehabilitation Therapy,
Kingston, Ontario, Canada.
STUDY DESIGN: Parallel-group randomized controlled trial.
OBJECTIVE: Establish the short-term effectiveness of chiropractic therapy for spinal pain compared with a sham intervention and explore the predictors of chiropractic treatment satisfaction.
SUMMARY OF BACKGROUND DATA: Chiropractic treatment is widely used for spinal pain. However, a lack of sound evidence precludes conclusions about the effectiveness of chiropractic for spinal pain.
METHODS: Participants were adults experiencing spinal pain, randomized to receive 2 treatments of chiropractic or sham therapy. Participants and outcome assessors were blinded to group allocation. Primary outcomes at 2 weeks were pain intensity (0–10 scale) and function (0–40 Functional Rating Index). Secondary outcomes were global change, minimum acceptable outcome, and treatment satisfaction. Treatment effects were estimated with linear mixed models for the primary outcomes. We used logistic regression to identify differences in the secondary outcomes and explore for predictors of treatment satisfaction.
RESULTS: One hundred eighty three participants (chiropractic, n = 92; sham, n = 91) were recruited and included in the analyses. Participants receiving chiropractic therapy reported greater improvements in pain (mean difference, 95% confidence interval [CI] = 0.5 [0.1–0.9]), physical function (mean difference [95% CI] = 2.1 [0.3–4.0]), and were more likely to experience global improvement (48% vs. 24%, P = 0.01) and treatment satisfaction (78% vs. 56%, P < 0.01). There was no between-group difference in achieving a minimally acceptable outcome (34% sham vs. 29% chiropractic, P = 0.42). Awareness of treatment assignment and achieving minimally important improvement in pain intensity were associated with chiropractic treatment satisfaction.
CONCLUSION: Short-term chiropractic treatment was superior to sham; however, treatment effects were not clinically important. Awareness of treatment assignment and clinically important reductions in pain were associated with chiropractic treatment satisfaction.
Key words: back pain, neck pain, effectiveness, chiropractic,
manipulation, spinal, randomized controlled trial, clinical trial.
From the FULL TEXT Article:
According to the 2010 Global Burden of Disease study,
musculoskeletal disorders were the second leading
kcause of disability throughout the worid.  In terms of
individual disorders, the 2 most common forms of spinal pain,
low back pain and neck pain, ranked respectively as the leading and fourth leading cause of disability-adjusted life years, 
This level of disability results in a substantial socioeconomic
burden in both direct medical costs and indirect costs such as
work absence and decreased productivity. [1–4] Hence, effective
management of spinal pain is an important issue for patients,
clnicians, and health care policy makers.
In high-income countries chiropractic treatment is widely
used for spinal pain. [3, 5] However, recent systematic reviews
have reported that small effect sizes of treatment and methodological limitations in published studies raise uncertainty
about the value of chiropractic treatment. [6–9] A primary limitation of previous studies is the lack of randomized controlled
trials comparing the effects of chiropractic treatment to inert
interventions for spinal pain. [6–9]
Accordingly, our primary aim was to examine the comparative effectiveness of a brief chiropractic intervention compared
with sham treatment for participants with spinal pain. The
secondary aim was to explore the clinical and demographic
variables associated with treatment satisfaction.
MATERIALS AND METHODS
In this article, we report the secondary analysis of a 2–arm
parallel-group randomized trial that compared the effectiveness
of usual chiropractic treatment to a sham intervention.
The primary analysis examined the occurrence of adverse
events and this has been published elsewhere.'" The protocol
for this trial was published and the trial was registered
with the Australian New Zealand Clinical Trials Registry
(ACTRN12611000542998)." All data were collected during
the 3 months between August 2012 and October 2012 in 12 Western Australian metropolitan chiropractic clinics.
Ethics approval was obtained from Murdoch University's
Human Research Committee (2011/109). The information
letter provided to potential participants stated that the study
will compare one type of chiropractic treatment that has
unknown benefits for back pain with another type of chiropractic
treatment that is not thought to be beneficial for back
pain. These words were accepted by the Human Research
Ethics Committee and written informed consent was obtained
from all participants prior to inclusion in this study.
Recruitment and Eligibility Criteria
We recruited participants from the local community using newspaper
advertisements. All included participants were 18 years or
older; English literate; had current spinal pain (neck, midback,
or low back pain) of at least 1–week duration; and scored at
least 3 out of a maximum 10 on the Numerical Rating Scale
(NRS) for pain,  and 12 out of a maximum 40 on the Functional
Rating Index (FRI). 
Participants were excluded if they thought they would be
unable to tolerate any intervention potentially provided in usual
chiropractic care including: manipulative therapy, mobilization,
traction, massage, ultrasound, and physical modalities.
Participants were also excluded if they had: spinal pain
related to cancer or infection, spinal fracture, spondyloarthropathy,
known osteoporosis, progressive upper or lower limb weakness,
symptoms of cauda equina syndrome or other significant
neurological condition, recent disc herniation, known severe
cardiovascular disease, uncontrolled hypertension, cognitive
impairment, blood coagulation disorder, previous spinal surgery
in the past year, previous history of stroke or transient ischémie
attacks, pacemaker or other electrical device implanted, substance
abuse issues, pregnancy, or a current compensation claim.
Participants were assigned to either a sham group or a usual
chiropractic care group, whereupon 2 treatments were provided
with approximately 1–week between treatments. Chiropractors
providing either the sham or usual chiropractic
treatment attended a 3–hour training session in which the trial
protocols were detailed and the administration of the sham
intervention was demonstrated. Ongoing guidance was also
provided to the chiropractors throughout the trial. To be eligible,
all chiropractors were required to practice within the
Western Australian metropolitan region of Perth and were
registered with the Chiropractic Board of Australia.
Four chiropractors in this group delivered the following procedures
at each visit
(1) detuned ultrasound ;
(2) an Activator
instrument (Activator Methods International, Ltd., Phoenix,
AZ),  a hand held device that delivers a low impulse thrust,
but was delivered at its lowest output and randomly administered
on or around the spine through a tongue depressor to
disperse any remaining force; and
(3) a randomly placed hand
on the spine while the detuned ultrasound head was placed on
the participant's back/neck to give a "hands on" experience.
As part of their training, the 4 chiropractors were instructed
to show equal enthusiasm for the sham therapy as they would
for usual care.
Usual Chiropractic Care
Eight chiropractors in this group administered individualized
chiropractic care in line with their usual treatment approach.
All chiropractors were asked to adhere to Australian evidencebased
guidelines for acute musculoskeletal pain regarding the
use of imaging. 
A random number generator was used to create a permuted
block randomization list with variable block sizes of 8 to 12.
Allocation was concealed with group assignment sealed in
sequentially numbered, opaque envelopes. Staff not administering
baseline or outcome measures opened the envelope and
allocated eligible participants to 1 of the intervention groups.
Staff administering baseline or outcome measures were
blinded to group allocation.  For this effectiveness analysis,
the primary outcomes were pain intensity, measured on an
11–point NRS and derived by averaging current, best, and
worst pain intensity in the preceding 48 hours ; and physical
function assessed by the FRl.  Secondary outcomes were
treatment satisfaction (5 response options ranging from
very dissatisfied to very satisfied),  global perceived change
(11–point scale ranging from – 5 to 5),  and minimal acceptable
outcome (MAO).  We also administered at baseline the
Pain Catastrophising Scale,  STarT Back Screening Tool, 
and the Fear Avoidance Beliefs Questionnaire.  Participants'
ability to determine which group they had been allocated to
was assessed by the Bang Blinding Index.  All outcome measures
were assessed at 2–week follow-up.
Our a priori sample size estimation for the primary analysis
was based on detecting a 20% difference in the occurrence of
adverse events between the 2 treatment groups. This analysis
required the recruitment of 180 study participants as necessary
to achieve 80% power. In this analysis, we were interested
in measuring differences in treatment outcome comprising
the minimal clinically important differences (MCIDs) of
9 points on the FRF  and 2 points on the NRS.  Considering
variance estimates from previous studies, [24, 25] and alpha equal
to 0.05, we achieved 82% and 99% power to detect clinically
important between-group differences in physical function and
pain intensity, respectively.
Data were analyzed using SPSS version 21 (IBM Corp.,
Armonk, NY). Treatment effects were estimated using separate,
random-intercept linear mixed models for the outcomes
of pain intensity and physical function. Time (baseline and
2–week follow-up) and treatment group (sham or usual chiropractic)
were modeled as fixed effects. The hypothesis of
interest was the time by group interaction, which we examined
with pair-wise comparisons of the estimated marginal
means. We included sex and the baseline score of the outcome
variable as covariates. Gonsistent with the intention to treat
priticiple, the linear mixed models estimated values for missing
data based on available scores; therefore all assigned participants
were included in the analyses.
Global perceived change was dichotomized by using a cutoff
point of 2 or more, leaving 2 categories "improved" and
"not improved." We assessed MAO by calculating the proportion
in each group who achieved their MAO value.  Treatment
satisfaction was dichotomized by combining "satisfied"
and "very satisfied" and combining "no preference," "dissatisfied,"
and "very dissatisfied," leaving 2 categories "satisfied"
and "not satisfied." The proportions of participants reporting
global improvement, achieving a MAO and experiencing
treatment satisfaction were compared using logistic regression.
Participant sex was modeled as a covariate. Missing data were
handled with multiple imputation using Rubin rules. 
Finally, we used bivariate logistic regression to examine the
relationship between treatment satisfaction and the following
clinical and outcome variables: group assignment; age; sex;
baseline pain intensity; baseline physical function; Pain Gatastrophising
Scale summary scale total, along with rumination,
magnification, and helplessness subscale totals; Fear Avoidance
Beliefs Questiormaire Work and Physical Activity subscale
scores; low, moderate, and high-risk STarT Back subgroups ;
adverse event oeeurrenee (Yes/No, based on partieipant's subjective
assessment); meeting MCID threshold for the NRS and
FRI; meeting the MAO; and blinding success.
Of the 272 potential participants we screened, 198 satisfied
selection criteria. One hundred eighty three participants were
randomized to the sham intervention group (n = 91) or usual
care group (n = 92). Participant flow through the study is
displayed in Figure 1.
There were no important baseline differences in démographie
details or clinieal eharacteristics, except for a higher
percentage of females in the usual care group (42% compared
with 31%). Participant baseline demographic details and clinical
characteristics are displayed in Table 1.
At baseline, the overwhelming majority of patients (98%)
had experienced spinal pain for more than 3 months. Threequarters
had experienced spinal pain for more than 5 years
(75% in the sham group; 73% in the usual care group). The
vast majority indicated that it had been more than 1 year since
last experiencing a 4–week pain-free period (89% in the sham
group; 98% in the usual care group), and more than twothirds
reported it had been more than 1 year sinee experieneing
a pain-free period of at least 1 week (71% in the sham
group; 68% in the usual care group).
In total, 8 chiropractors (5 males) provided usual care and
4 chiropractors (2 males) delivered the sham intervention.
Chiropractors in the sham group had an average 3.6 (SD,
1.1) years clinical experience whereas chiropractors delivering
usual care had an average 12.6 (SD, 2.3) years clinical experience.
Most ehiropraetors had obtained their qualifieations
from Australian universities (8/11). All ehiropraetors were
registered with the national regulatory board and praetieed
Type of Therapies Used in Usual Care Group
Details about the speeifie therapies applied to participants in
the usual care group are displayed in Table 2. The frequency
of manipulation and mobilization at eaeh spine region are
displayed in Table 3.
Outcomes at 2 Weeks
Partieipants reeeiving usual ehiropraetie care experienced
greater improvements in pain intensity and physical function
than participants reeeiving the sham intervention (Table 4).
However, the observed differenees in treatment outcome were
not elinieally important. More participants experienced global
improvement when receiving the usual chiropractic care than
the sham intervention (48% improved vs. 24% improved,
? = 0.012). For MAO, 34% of the sham group, and 29% of
the usual care group, partieipants met their speeified threshold.
There was no signifieant differenee between groups in the
proportion of partieipants who met their MAO (P = 0.42).
Greater treatment satisfaction was reported by those in
the usual chiropractic group in comparison to those receiving
the sham intervention (78% satisfied vs. 56% satisfied,
P = 0.004). For the usual care group, the only significant
predictors of treatment satisfaction were meeting the MGID
threshold for pain intensity (odds ratio = 5.6:, 95% GI =
1.2–26.6) and correctly identifying group assignment (odds
ratio = 4.7; 95% GI = 1.5–14.6) (Table 5). For the sham
group, the only significant predictor of treatment success was
meeting the MGID threshold for pain intensity (odds ratio =
4.6; 95% GI = 1.5–15.5) (Table 5).
The proportion of participants who correctly identified
their assigned treatment was 67% for the sham group and
85% for the usual care group. Bang Index values showed that
25% of the sham group (95% GI = 10%–40%) and 6 1%
of the usual care group (95% GI = 48%–74%) guessed correctly
beyond what would be expected by chance. 
There were no serious adverse events. Gommon adverse
events were increased pain (sham group, 29%; usual care
group, 36%), muscle stiffness (sham group, 29%; usual
care group, 37%), and headache (sham group, 17%; usual
care group, 9%).
This seems to have been only the second study to use a shamcontrolled
design to examine the effectiveness of chiropractic
treatment. Our finding that chiropractic treatment for spinal
pain produced a statistically significant difference, but not a
clinically meaningful difference, is consistent with the results
of that previous study.  Gonsidering spinal manipulation
more broadly, the finding that usual chiropractic treatment
is not superior to sham intervention is also consistent with
some, [28, 29] but not all, [30–33] previous studies. Hence, this study adds to the body of knowledge exploring whether spinal
manipulation for spinal pain provides an advantage compared
with sham intervention.
The small treatment effects observed in our study, and
indeed others, may result from the chiropractors treating
nonspecific spinal pain as a homogenous condition rather
than a collection of conditions with differing etiologies. 
If notispecific spinal pain does consist of heterogeneous
conditions, then a specific intervention such as chiropractic
treatment may be only effective in select cases. [6, 34] Previous
studies have identified a subgroup of patients with low back
pain who are likely to achieve clinical success with SMT. [35, 36]
The topic of subgrouping patients with nonspecific spinal
pain has been subject to much debate. [37–40] If additional studies
are conducted it may or may not define the subgroup of
patients with spinal pain better suited to chiropractic therapy.
The MAO has been proposed as an alternative method to
evaluate clinical outcome, based on a prospective minimum
threshold established by each patient.  In comparison to the
MCID, it provides a different perspective on treatment success
because not all patients have the same goal, and it enables an
evaluation of how frequently individual patient goals are met. 
In contrast to the other study outcomes, we found no betweengroup
difference in the proportion of participants achieving
their MAO. This finding adds to the complexity of identifying
the effectiveness of therapies for spinal pain and may highlight
the natural fluctuations experienced by patients with spinal
pain and the impact of nonspecific treatment effects.
In line with previous studies, we found that treatment
satisfaction was related to patients meeting the threshold
for MCID. [41, 42] But it was surprising that reaching the MAO
threshold was not associated with treatment satisfaction
because a previous study had shown it to be a strong predictor of satisfaction.  However, that study was the only one to have
examined the relationship between MAO and treatment satisfaction,
which suggests further studies are required to clarify
this relationship. 
The strengths of our study included a rigorous concealed
randomization procedure, blinded outcome assessors, the use
of valid, reliable outcome measures, and providing treatment
in a typical chiropractic setting. There were also several limitations.
First, we were generally unsuccessful in our attempt
to blind study participants to group allocation. This probably
resulted from inherent difficulties in identifying a credible sham
intervention for use in a chiropractic trial, or indeed many
types of randomized controlled trial.  Also, we did not ask the
participants if they had previously received chiropractic treatment.
If the sham group contained a reasonable number of
nonnaive participants, then this may have impacted substantially
on the success of the blinding procedure. Nonetheless,
short of using more aggressive blinding procedures such as
conscious sedation, it may not be possible to blind participants
successfully in trials involving treatments such as manual
therapy and exercise. 
Second, offering only 2 treatments
may not reflect typical chiropractic practice and recommendations
from clinical guidelines. [45–47] However, other studies
of chiropractic effectiveness have only provided 2 treatments
and the evidence suggests that outcomes after 2 chiropractic
visits are predictive of subsequent improvement. [6, 9, 48, 48]
we did not assess either anxiety or depression, and differing
levels of anxiety or depression may potentially have affected
clinical outcomes in either group. However, no important differences
were observed between groups in the psychosocial
characteristics measured at baseline including the Pain Catastrophising
Scale and Fear Avoidance Beliefs Questionnaire.
Finally, the chiropractors delivering the sham intervention
were less experienced than the chiropractors providing usual
care. However, clinician experience does not seem to infiucncc
clinical outcome among patients receiving spinal manipulative
therapy,  and in any event the chiropractors delivering
sham did not provide spinal manipulative therapy.
Future research should concentrate on identifying clinically
relevant spinal pain subgroups to which chiropractic and
other manual therapy treatments may be best suited. It would
also be worthwhile to identify credible sham interventions and
to conduct studies examining how nonspecific effects, such as
interpersonal attributes, contribute to treatment outcomes.
Participants receiving chiropractic therapy reported
greater improvements in pain and physical function.
Chiropractic therapy for spinal pain did not produce
a clinically important effect.
Awareness of treatment assignment and achieving
minimally important improvement in pain
intensity were associated with chiropractic
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