Headache: J Head and Face Pain. 2019 (Apr); 59 (4): 532–542 ~ FULL TEXT
Pamela M. Rist, ScD; Audrey Hernandez, MS; Carolyn Bernstein, MD; Matthew Kowalski, DC;
Kamila Osypiuk, MS; Robert Vining, DC; Cynthia R. Long, PhD; Christine Goertz, DC, PhD;
Rhayun Song, RN, PhD; Peter M. Wayne, PhD
Division of Preventive Medicine,
Department of Medicine,
Harvard Medical School and Brigham and Women's Hospital,
Boston, MA, USA.
BACKGROUND: Several small studies have suggested that spinal manipulation may be an effective treatment for reducing migraine pain and disability. We performed a systematic review and meta-analysis of published randomized clinical trials (RCTs) to evaluate the evidence regarding spinal manipulation as an alternative or integrative therapy in reducing migraine pain and disability.
METHODS: PubMed and the Cochrane Library databases were searched for clinical trials that evaluated spinal manipulation and migraine-related outcomes through April 2017. Search terms included: migraine, spinal manipulation, manual therapy, chiropractic, and osteopathic. Meta-analytic methods were employed to estimate the effect sizes (Hedges' g) and heterogeneity (I2) for migraine days, pain, and disability. The methodological quality of retrieved studies was examined following the Cochrane Risk of Bias Tool.
RESULTS: Our search identified 6 RCTs (pooled n = 677; range of n = 42–218) eligible for meta-analysis. Intervention duration ranged from 2 to 6 months; outcomes included measures of migraine days (primary outcome), migraine pain/intensity, and migraine disability. Methodological quality varied across the studies. For example, some studies received high or unclear bias scores for methodological features such as compliance, blinding, and completeness of outcome data. Due to high levels of heterogeneity when all 6 studies were included in the meta-analysis, the 1 RCT performed only among chronic migraineurs was excluded. Heterogeneity across the remaining studies was low. We observed that spinal manipulation reduced migraine days with an overall small effect size (Hedges' g = –0.35, 95% CI: –0.53, –0.16, P < .001) as well as migraine pain/intensity.
CONCLUSIONS: Spinal manipulation may be an effective therapeutic technique to reduce migraine days and pain/intensity. However, given the limitations to studies included in this meta-analysis, we consider these results to be preliminary. Methodologically rigorous, large-scale RCTs are warranted to better inform the evidence base for spinal manipulation as a treatment for migraine.
KEYWORDS: disability; migraine; pain; spinal manipulation
From the FULL TEXT Article
Thirty-eight million adults in the United States are
estimated to be migraine sufferers; of these, 91% experience
migraine-associated disability. [1–3] Traditionally,
abortive and prophylactic medications are first-line
treatment for migraine therapy, with most migraineurs
treating their headaches at the onset of symptoms. 
However, approximately 40% of those with episodic
migraine have unmet treatment needs.4 Of these
patients, one-third report dissatisfaction with current
treatment and about half report moderate or severe
headache-related disability.  In addition, commonly
prescribed rescue medications (eg, analgesics, ergots,
triptans, and opioids) may increase the risk of medication
overuse headaches, allodynia, and dependence. 
The limitations to current pharmacological therapies
have highlighted the need to explore alternative or
integrative treatments for migraine.
One potential non-pharmacological approach to
the treatment of migraine patients is spinal manipulation,
a manual therapy technique most commonly
used by doctors of chiropractic, but also practiced by
some physical therapists and osteopathic physicians.
A recent cross-sectional survey using data from the
US National Health Interview Survey estimated that
approximately 15.4% of individuals with migraine
have used chiropractic care (which can include spinal
manipulation) in the past 12 months.  Given the
prevalence of migraine, this may translate into a substantial
disease burden in chiropractic care clinics
because 94% of spinal manipulation for which reimbursement
is sought in the United States is delivered
by chiropractors. 
For example, a survey of Australian
chiropractors found that 53% of chiropractors
reported managing patients with migraine “often”
and 40.9% of chiropractors reported managing
patients with migraine “sometimes.”  In the United
States, approximately 12% of patients seeking treatment
from a chiropractor report headache as their
chief complaint.  Given the prevalence of migraine
patients seeking chiropractic care and the need for evidence-
based non-pharmacological approaches to treat
migraine, there is a need to understand whether spinal
manipulation, an integral component to chiropractic
care, is an effective non-pharmacological approach for
the treatment of migraine headaches.
Three systematic reviews have examined the effects
of spinal manipulation on migraine, [10–12] but
these reviews included only 3 randomized controlled
trials [13–15] and did not include a meta-analysis of the
effects seen in these studies. Since the publication of
these reviews, additional randomized controlled trials
on spinal manipulation have been conducted. [16–18]
The aim of this study is to provide a synthesis of available
clinical trials using a systematic review and to
perform a preliminary meta-analysis examining the
effects of spinal manipulation on migraine frequency,
pain, and disability.
Literature Search and Inclusion Criteria
Our literature search strategy and inclusion criteria were
specified a priori. In accordance with PRISMA
guidelines, we searched the Cochrane Library and
PubMed, which includes MEDLINE, for relevant
articles from inception through April 2017. The
following search terms were used: spinal manipulation,
osteopathic, chiropractic, manual therapy, and
migraine. The search was limited to articles identified
as clinical trials in PubMed. To expand the selection,
we also manually searched the reference lists of all
We included randomized
clinical trials (RCTs) where the primary intervention
was spinal manipulation and the primary disorder
investigated was migraine headaches. No exclusions
were made on the basis of provider type (eg, chiropractic
vs osteopathic) or area of the spine manipulated.
Data Extraction and Syntheses
extracted independently by 2 researchers (AH,
RS) utilizing a standardized template generated in
Microsoft Excel. Admissible data included the study
design, duration and frequency of the intervention,
sample size, type of control, and outcome measures.
The decisions about what data to extract were made
Three authors (AH, KO, PR)
individually assessed the methodological quality of
RCTs using the 7–item Cochrane Collaboration Tool
for assessing risk of bias.19 The criteria were
selected a priori and included:
(1) random sequence generation,
(2) allocation concealment,
(3) blinding of participants,
(4) blinding of outcome assessment,
(5) incomplete outcome data,
(6) selective reporting (including reporting of all outcomes and specifying a primary outcome), and
(7) other bias.
bias,” we evaluated the studies for the following
criteria: group similarity at baseline with regard to the
outcome measures, similarity in co-intervention,
compliance, timing of outcome assessments, rationale
for sample size, rationale for control group, and
intervention description (see Supplemental Table 1
for full descriptions of these items). Per established
criteria, the evaluated domains were judged as
low risk, high risk, or unclear bias. In the case of
evaluation discrepancies, the authors discussed and
came to an agreement.
We reviewed the studies for
the inclusion of formal protocols that methodically
monitored adverse events, and whether any adverse
events reported were a direct result of the intervention.
Data Analysis and Syntheses
study, the mean and standard deviation (SD)
values at baseline and post-intervention for the
primary and secondary outcomes were extracted.
Other data extracted included t score or P value
between groups and the sample size (N) in each
group. If such data were not available, the standard
error values, confidence intervals, or medians with
interquartile ranges were translated into mean and
SD following suggested statistical formulas. [19, 20] The
most common outcomes assessed across all studies
were migraine days and measures of migraine-related
pain and disability. Migraine days was used as our
Effect sizes (Hedges’ g ) and 95% confidence
intervals using random and fixed effects models were
calculated by Comprehensive Meta-Analysis Version
3.0 software (CMA v3, Biostat, Inc., Frederick,
MD, USA). Effect sizes of 0.2, 0.5, and 0.8 are considered
small, medium, and large, respectively. 
Heterogeneity was assessed by calculating the Q value
and I2 statistics. A low P value for the Q statistic or
an I2 ratio greater than 75% indicated heterogeneity
across the studies. The pooled effect sizes for the most
common outcomes were calculated. For the primary
analyses, we calculated pooled effect sizes comparing
the intervention group to all possible control groups.
If an article had 2 different control groups, the sample
size of the intervention group was divided by 2 to
avoid overweighting the study. In secondary analyses,
subgroup analyses were performed for active controls
and passive controls.
Study Selection and Characteristics
search is summarized in Figure 1. The initial search
identified 76 clinical trials. The titles and abstracts
were assessed for inclusion. After the removal of
duplicate records, 48 remained for further assessment.
Of those, 21 were not RCT studies and 1 text was
unavailable in English. The remaining 26 studies
were further assessed for eligibility. Of the remaining
clinical trials, 19 did not use spinal manipulation as
a treatment and 1 did not present original data. The
6 remaining clinical trials [13–18] were included in the
overall quantitative synthesis, 3 of which have been
included in previous systematic reviews. [13–15] Two of the
trials were registered in clinicaltrials.gov. [16, 17]
Participant Characteristics and Study Setting
6 clinical trials identified in our literature review are
summarized in Table 1. A total of 677 patients were
randomized into these studies; 670 patients had
baseline assessments and could be included in analyses.
The average age of participants at baseline was
39.3 years and 75.0% were female. All studies allowed
patients to continue use of their current medications.
Five studies enrolled episodic migraine patients and
the minimum number of migraine attacks per month
needed to be eligible ranged from 1 to 4. [13–15, 17, 18] Only
1 study enrolled patients diagnosed with chronic
migraine according to ICHD-II criteria. 
Intervention and Control Group Characteristics
All studies used a parallel-arm design in which
participants were assigned to a spinal manipulation
treatment group or to a control group (either active or
passive controls). While there was heterogeneity in the
specific type of spinal manipulation techniques used
in each study, the techniques used in the treatment
groups were applied with the intent to influence the
function of joints and the tautness of soft tissue.
The spinal manipulations were performed by a chiropractor
in 3 studies, [13, 15, 17] an osteopathic physician
in 2 studies, [16, 18] or by either a medical practitioner,
physiotherapist, or chiropractor in 1 study.  The
duration of the intervention ranged from 2 to 6 months,
with the number of treatments ranging from 8 to 16.
The type of control group used varied across the
studies. Five of the 6 studies employed active controls
where the intervention group was compared to
sham therapy, [16, 17] cervical mobilization (movement
of joints within normal limitations),  detuned
interferential therapy (which served as a “placebo”
therapy),  or a combination of spinal manipulation and
amitriptyline treatment. 
In addition to having an
active control, 3 studies also contained a second
“passive” control arm where patients were allowed
to either continue usual pharmacological therapy, 
change medications as their physician directed,  or
were assigned to take amitriptyline.  The sixth study
only used a “passive” control group and compared
those receiving the intervention to those not
receiving spinal manipulation, sham treatment, or
physical therapy.  In this study, all participants were
allowed to continue their previously prescribed
Of the 6 studies, 5 assessed
their outcomes through the use of migraine diaries. [13–17]
In addition to using migraine diaries, 2 studies also
administered questionnaires to assess some outcomes
at set time points during the study. [13–16] One study
only assessed outcomes through questionnaires. 
Migraine days per month or the frequency of migraine
attacks was assessed in all studies and was our
primary outcome. We also analyzed migraine intensity
or migraine pain [13–18] and measures of migraine
disability. [14–16, 18]
Of the 6 RCTs, only 2 studies explicitly
reported adverse events or adverse effects. [16, 17]
The first reported that adverse effects were an item in
headache diaries but provided no additional reporting
details. No adverse effects were reported during this
trial.  The second study reported that all adverse
events were recorded after each intervention session
but it was unclear how adverse events were recorded
for those in the usual pharmacological management
group. Few adverse events were observed and none
were considered serious or severe.  A third study
reported the prevalence of neck pain among those
receiving spinal manipulation but not among the
other groups and the authors did not report other
adverse events. 
Risk of Bias Assessment
Table 2 displays the
results from our risk of bias assessment. Only 3 studies
were judged to be low risk of bias for the random
sequence generation and for allocation concealment. [13, 16, 17] Given the nature of the intervention and
control treatment chosen, most studies were unable to
blind participants. [13–15, 18] Two studies did use a “sham”
spinal manipulation for 1 of their control groups, which
allowed blinding of participants in the intervention and
“sham” groups but not those in medication only or usual
pharmacological management control groups. [16, 17]
Both studies also provided information to demonstrate
that blinding of participants in the “sham” group
was successful. [16, 17] One study found that none of
the patients in the sham group were able to correctly
guess the nature of their treatment.  The other study
asked participants after each session whether they
believed they had received spinal manipulation. Over
80% of participants believed they had received
spinal manipulation regardless of group allocation. 
Because participants self-reported all outcomes,
lack of blinding of participants directly impacted our
assessment of blinding of the outcomes.
Only the 2
studies that used “sham” groups received low risk of
bias scores for blinding of the outcomes. [16, 17] Some
studies did mention that the analyst was blinded
to the treatment assignment of participants  or that
the outcomes assessor was blinded.  Only 2 studies
provided enough information to show low attrition
rates during the course of the study (“incomplete
outcome data” criteria). [14, 16] All studies provided
information on all outcome measures mentioned in the
methods section, but 3 studies did not specify a primary
outcome. [14, 15, 18] For other biases, the most noticeable
result was that 5 studies provided insufficient detail
to determine participant compliance. Three studies
did not provide sample size rationale. [14, 15, 18]
Effects of Spinal Manipulation on Migraine Days/Frequency of Migraine
All 6 studies provided
information on migraine days per month [15–17] or in the
past 3 months,  percentage of days with headache in the
past 4 weeks,  or the “mean frequency of attacks.” 
The originally planned a priori meta-analysis
including all 6 studies using a random effects model
indicated that spinal manipulation had a greater
impact on reducing the number of migraine days
compared to controls with an overall large effect size
(Hedges’ g = –1.16, 95% CI: –1.94, –0.39, P = .003)
(Supplemental Table 1).
across the 6 studies was high (I2 ratio = 93.80%) and
appeared to be driven by the study by Cerritelli et al, 
which only enrolled chronic migraineurs and showed
effect sizes that were substantially larger than the other
studies. Due to concerns that arose during peer review
that even a random effects model would not adequately
capture this between study heterogeneity across all
6 studies, we decided post hoc (ie, after performing
our initial analyses) to exclude the study by Cerritelli
et al from our main analyses. Results from analyses
including this study can be found in the Supporting
Information and generally were of stronger magnitude
than those presented here.
After excluding this study, heterogeneity across the remaining studies was low
(Q statistic = 3.61, P value = .72; I2 ratio = 0) and we
decided post hoc to use a fixed effects model. The
meta-analysis of the remaining 5 studies indicated
that spinal manipulation had a greater impact on
reducing the number of migraine days compared to
controls with an overall small effect size (Hedges’
g = –0.35, 95% CI: –0.53, –0.16, P value < .001) using
a fixed effects model. As a sensitivity analysis, we
also performed this analysis using a random effects
model and observed the same results (Hedges’
g = –0.35, 95% CI: –0.53, –0.16, P value < .001).
The effect size was similar when the analysis was
restricted to studies that compared the intervention
group to active controls (4 studies; Hedges’ g = –0.41,
95% CI: –0.64, –0.17, P value = .001). The overall
effect size was slightly smaller when comparing the
interventional group to passive controls (3 studies;
Hedges’ g = –0.25, 95% CI: –0.56, 0.06, P value = .117,
Effect of Spinal Manipulation on Migraine Pain or Intensity
A measure of migraine pain or intensity
was used in all studies usually through a Likert
scale or visual analog scale. However, 1 study  used
MIDAS B and the German “Pain Questionnaire” to
assess migraine pain. Analyses excluding the study
by Cerritelli et al  observed that spinal manipulation
had greater impact on reducing migraine pain or
intensity with an overall small effect size (Hedges’
g = –0.28, 95% CI: –0.46, –0.09, P value = .004)
from a fixed effects meta-analysis (Q statistic = 3.26,
P value = .77; I2 = 0). This effect was similar when
restricting analyses to active control groups (Hedges’
g = –0.23, 95% CI: –0.46, 0, P value = .050) or to
passive controls t (Hedges’ g = –0.36, 95% CI: –0.67,
–0.04, P value = .027, Fig. 3).
Effects of Spinal Manipulation on Migraine Disability
Only 4 studies provided information on
migraine disability. Measures of disability varied
across studies and included assessments of number of
hours before returning to work,  “mean disability,” 
disturbance in occupation due to migraine and
days of disablement from MIDAS 1,  and functional
disability and the HIT-6.  After excluding the study
by Cerritelli et al,  we observed a small effect size
in a fixed effects meta-analysis (Q statistic = 0.34,
P value = .84; I2 = 0) (Hedges’ g = –0.16, 95% CI:
–0.43, 0.12, P value = .265). Due to the limited
number of studies, we were not able to perform
subgroup analyses among active and passive controls
Results from this preliminary meta-analysis suggest
that spinal manipulation reduced migraine days
and migraine pain or intensity with an overall small
effect size and did not impact migraine disability
compared to control interventions.
Subgroup analysis stratified by control group
type (active vs passive) showed similar magnitudes of
effects as the main analyses. Performing analyses
stratified by the type of control group used is important
because there is concern that beneficial effects of
an “active” intervention, like spinal manipulation,
may be due solely to the increased attention given to
the intervention group. While use of an “active” control
group (eg, sham manipulation or placebo therapy)
may help to avoid this potential bias, developing sham
manipulations that are nontherapeutic is a challenge.
In this meta-analysis, spinal manipulation was associated
with significant reductions in migraine days compared
to those in active control groups which suggests
that the results seen for the intervention group are not
solely due to attention or expectation.
Our risk of bias assessment also indicated areas in
which some studies received high bias scores (eg, random
sequence generation, allocation concealment,
blinding of participants and personnel, prespecifying
a primary outcome, and reporting on compliance).
Identifying areas where prior studies have shown limitations
may help guide and strengthen the scientific
rigor of future research in this field. For example,
prespecifying the primary outcome as well as collecting
and reporting on compliance over the course of
a study should be implemented in all future trials of
spinal manipulation. Blinding of participants in studies
of spinal manipulation can be difficult depending
upon the type of comparison group used in the trial.
Two recent studies used sham therapy for one of their
control groups. Both formally evaluated the blinding
of participants and observed that it was possible to
achieve blinding in trials of spinal manipulation. [16, 17]
Even if participants are unable to be blinded (eg, when
spinal manipulation is compared to pharmacological
treatment alone), individuals analyzing the data
should be blinded to treatment group assignment.
The exact mechanisms by which spinal manipulation
may influence migraine days, pain, and disability
are not yet known but a few hypotheses have
been proposed. Cerritelli et al suggested that spinal
manipulation may affect migraine through the rebalance
of the vegetative nervous system nuclei or by the
reduction of proinflammatory substances.16 Chaibi et
al suggested that spinal manipulation may stimulate
neural inhibitory systems by activating central descending
inhibitory pathways. 
Although the results of this meta-analysis suggest
that spinal manipulation may reduce migraine days
and migraine pain/intensity, several important limitations
should be discussed. Given the variation in
study quality and specific study design features, we
consider the results of these meta-analyses to be preliminary.
Additional well-designed trials are needed
before a definitive statement on the use of spinal manipulation
for migraine can be made. Unfortunately,
the low number of studies included in the metaanalysis
prohibited us from using meta-regression
to formally quantify the effects of different design
features on our results. In addition, the populations
enrolled in these studies varied. In particular,
the study by Cerritelli et al enrolled a population of
chronic migraineurs,16 while other studies enrolled
participants who experienced as few as 1 migraine per
The study of chronic migraineurs observed
larger effect estimates than any of the other studies
included in our meta-analysis.  Until more studies of
both chronic and episodic migraine are performed,
we cannot determine if there are differences in the
effect of spinal manipulation on chronic vs episodic
migraine. Although all studies examined a measure
of migraine days, there was often variability in the
assessments of migraine pain/intensity or migraine
disability. This limited our ability to determine the
influence of spinal manipulation on other migraine
outcomes. We were also unable to explore the effect
of spinal manipulation on different follow-up lengths
due to the limited number of studies and assessment
time points in each trial. We limited our systematic
review and meta-analysis to studies listed in PubMed
which would exclude trials that were never published.
This may result in publication bias if trials which
were not able to be completed or which had null results
were not published. A search of clinicialtrials.
gov identified 2 additional ongoing trials (1 not yet
recruiting and 1 currently recruiting) which should
be included in future systematic reviews of spinal manipulation
for migraine. We were unable to formally
assess publication bias using a funnel plot due to the
low number of studies included in this meta-analysis.
Only 2 studies explicitly collected adverse events.
In order to fully understand the benefits and risks of
spinal manipulation for migraineurs, more rigorous
assessments of potential adverse events should be
performed. Adequate monitoring of adverse events
is particularly important in this population because
of concerns that cervical manipulation may be
associated with cervical artery dissection  and the
increased risk of cervical artery dissection among
migraineurs. [23, 24] Further understanding of the potential
risks and benefits of spinal manipulation for migraineurs
may help migraineurs and their physicians
determine the best course of care.
Most studies included in this review focused
on spinal manipulation techniques. While spinal
manipulation is one feature of chiropractic care,
physical therapy, and osteopathy, current therapeutic
models typically encompass a multimodal
approach including but not limited to education,
spinal stabilization exercises, soft tissue manipulation,
breathing training, stretching techniques,
nutrition, and ergonomic modifications. [25–27] It is
currently unknown whether the wide variety of
potential multimodal care models as practiced in
clinical settings reduce migraine days, pain, or
Results from this preliminary meta-analysis suggest
that spinal manipulation may reduce migraine
days and pain/intensity. However, variation in study
quality makes it difficult to determine the magnitude
of this effect. Methodologically rigorous, large-scale
RCTs are warranted to better inform the evidence
base for the role of spinal manipulation in integrative
models of care provided by chiropractors, physical
therapists, and osteopathic physicians as a treatment
STATEMENT OF AUTHORSHIP
(a) Conception and Design
Pamela M. Rist, Rhayun Song, Peter M. Wayne
(b) Acquisition of Data
Audrey Hernandez, Kamila Osypiuk, Rhayun
(c) Analysis and Interpretation of Data
Pamela M. Rist, Audrey Hernandez, Carolyn
Bernstein, Matthew Kowalski, Kamila Osypiuk,
Robert Vining, Cynthia R. Long, Christine
Goertz, Rhayun Song, Peter M. Wayne
(a) Drafting the Manuscript
Pamela M. Rist, Audrey Hernandez, Kamila
Osypiuk, Robert Vining, Cynthia R. Long,
Christine Goertz, Rhayun Song, Peter M. Wayne
(b) Revising It for Intellectual Content
Pamela M. Rist, Carolyn Bernstein, Matthew
(a) Final Approval of the Completed Manuscript
Pamela M. Rist, Audrey Hernandez, Carolyn
Bernstein, Matthew Kowalski, Kamila Osypiuk,
Robert Vining, Cynthia R. Long, Christine
Goertz, Rhayun Song, Peter M. Wayne
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