Pain Medicine, 23(3), 2022, 579–589

https://doi.org/10.1093/pm/pnab312
Advance Access Publication Date: 23 October 2021
Original Research Article

HEADACHE & FACIAL PAIN SECTION

The Effect of Adding Dry Needling to Physical Therapy in

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the Treatment of Cervicogenic Headache: A Randomized
Controlled Trial
sar Ferna
Seyedeh Roghayeh Mousavi-Khatir, PhD,* Ce ~ as, PhD,† Payam Saadat, MD,‡
ndez-de-las-Pen
§ ¶
Khodabakhsh Javanshir, PhD, and Amirhossein Zohrevand, MD

*Department of Physiotherapy, School of Rehabilitation, Babol University of Medical Sciences, Babol, Iran; †Department of Physical Therapy,
on, Madrid, Spain; ‡Department of Psychiatry,
Occupational Therapy, Physical Medicine and Rehabilitation, Universidad Rey Juan Carlos (URJC), Alcorc
School of Medicine, Mobility Impairment Research Center, Babol University of Medical Sciences, Babol, Iran; §Mobility Impairment Research Center,
Physiotherapy Department, Babol University of Medical Sciences, Babol, Iran; ¶Department of Surgery, School of Medicine, Babol University of
Medical Sciences, Babol, Iran

Correspondence to: Khodabakhsh Javanshir, PhD, Babol University of Medical Sciences, Gnaj Afrooz Street, P.O.Box: 4717647745, Babol, Iran.
Tel: þ98 (11) 32199592, þ989111140315; Fax: þ98 (11) 32190181; E-mail: khodabakhshjavanshir@gmail.com.

Conflicts of interest: There are no conflicts of interest to report.

Funding sources: None.

Received on 27 April 2021; Accepted on 3 October 2021

Abstract
Objective. To compare the long-term effect of adding real or sham dry needling with conventional physiotherapy
in cervicogenic headache. Design. A randomized controlled trial. Setting. Physiotherapy Clinic, Rouhani
Hospital of Babol University of Medical Sciences, Iran Subjects. Sixty-nine patients with cervicogenic headache.
Methods. Patients were randomly assigned into a control group (n ¼ 23) receiving conventional physical therapy; a
dry needling group (n ¼ 23) receiving conventional physical therapy and dry needling on the cervical muscles; pla-
cebo needling group (n ¼ 23) receiving conventional physical therapy and superficial dry needling at a point away
from the trigger point. The primary outcome was the headache intensity and frequency. Neck disability, deep cervi-
cal flexor performance, and range of motion were secondary outcomes. Outcomes were assessed immediately after
treatment and 1, 3, and 6 months later. Results. Sixty-five patients were finally included in the analysis. Headache in-
tensity and neck disability decreased significantly more in the dry needling compared to sham and control groups
after treatment and during all follow-ups. The frequency of headaches also reduced more in the dry needling than in
control and sham groups, but it did not reach statistical significance. Higher cervical range of motion and enhance-
ment of deep cervical flexors performance was also observed in the dry needling compared to sham and control
groups. Conclusion. Dry needling has a positive effect on pain and disability reduction, cervical range of motion, and
deep cervical flexor muscles performance in patients with cervicogenic headache and active trigger points, although
the clinical relevance of the results was small. Trial registration. The trial design was registered in the Iranian Registry
of Clinical Trials (www.irct.ir, IRCT20180721040539N1) before the first patient was enrolled.

Key Words: Cervicogenic Headache; Dry Needling; Trigger Point; Physical Therapy

C The Author(s) 2021. Published by Oxford University Press on behalf of the American Academy of Pain Medicine.
V
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580
Introduction
Headache is a highly prevalent condition affecting 46%
of the general population [1, 2]. It is generally accepted
that headaches can have negative effects on the quality of
life of the individuals and impose socio-economic costs
for the society [3]. The International Headache Society
(IHS) classifies headaches as primary or secondary.
Cervicogenic headache (CGH) is a secondary headache
which is associated with cervical spine disorders [4]
and comprises about 15–20% of chronic and recurrent
headaches [5].
Pain from the upper cervical spine refers to the head
and can be perceived in one or more areas of the head [6,
7]. Although the exact cause of CGH is unknown, the
convergence of trigeminal and upper cervical spine neu-
rons in the trigemino-cervical nucleus caudalis can ex-
plain pain referral to the head [8]. Similarly, the
convergence of the sensory-motor fibers between the cra-
nial accessory nerve, the upper cervical nerve roots, and
the inferior branch of the trigeminal nerve can be also in-
volved in this process. In fact, this neural network consti-
tutes the anatomical basis for pain referral to the head
elicited by some muscles such as sternocleidomastoid or
upper trapezius [9].
Therapeutic interventions targeting structures that are
innervated by the trigeminocervical nucleus caudalis may
be effective for treating CGH [10]. There is evidence sup-
porting the presence of musculoskeletal dysfunctions in
the upper cervical spine segments (C1–C3) in patients
with CGH [11] and a potential effect of manual therapy
targeting the upper cervical spine joints [12–14]. CGH
seems to respond positively to physical therapy (PT)
treatment [15]. In fact, physical therapists use a variety
of techniques including mobilization or manipulation of
the upper cervical spine [14, 16–18], exercises, and pos-
tural correction [19–21] to treat CGH.
The role of neck muscles is also considered in CGH
related-pain [22]. There is evidence that myofascial trig-
ger points (TrPs) could play a relevant role in CGH [23,
24]. Active TrPs are those which stimulation reproduce
the symptoms in CGH patients, the pain pattern of a
headache attack [22, 25]. Previous evidence suggests that
peripheral nociception from active TrPs could contribute
to pain referral to the head contributing to excitability of
the trigeminocervical nucleus caudalis [22, 25]. Dry nee-
dling (DN) is an intervention commonly used by physio-
therapists for treatment of muscle pain associated with
TrPs [26]. The American Physical Therapy Association
(APTA) defined DN as “a skilled intervention to treat
myofascial TrP in the musculoskeletal disorders, which
involves inserting a thin filiform needle to penetrate the
skin and stimulate TrPs, muscles, and connective tissues”
[27]. Potential benefits of DN include an immediate
Mousavi-Khatir et al.
reduction in the local and referred pain [28], improve-
ment of reduced range of motion [29], and reduction of
peripheral and central sensitization [30, 31].
Evidence about the use of DN for CGH is lacking. A
systematic review showed insufficient evidence, due to
the lack of high quality randomized clinical trials, for
support or refuse its use in headaches [26]. Two prelimi-
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nary trials have investigated the immediate effects of DN
on CGH [23, 24]. The inconsistency of the interventions
as well as the lack of a proper control group and longer-
term follow-ups, makes it difficult to decide the use of
DN for treating CGH. In fact, despite the use of DN for
treating CGH, there is insufficient evidence to support
this intervention for this condition [26, 32]. No random-
ized clinical trial including sham and placebo groups
have investigated the effects of the application of DN in
CGH patients [26].
Therefore, the objective of this randomized controlled
trial was to investigate the effects of adding real or sham
DN combined with PT in people with CGH. We hypoth-
esized that patients with CGH receiving real DN com-
bined with PT would experience better clinical outcomes
than those receiving the sham needling combined with
PT or just PT alone.
Methods
Study Design
This study was a triple-blind, randomized, controlled
trial conducted at the Physiotherapy Clinic of Rouhani
Hospital of Babol University of Medical Sciences, Babol,
Iran. The study protocol was approved by the Research
Ethics Committee of the University (code 1397.071). The
trial design was prospectively registered in the Iranian
Registry of Clinical Trials (www.irct.ir,
IRCT20180721040539N1) before the first patient was
enrolled.
Participants
Consecutive patients with headache were screened for eli-
gible criteria between October 2018 and January 2020.
Data enrollment ceased when the target sample size was
obtained after applying exclusion criteria. During the re-
cruitment period, 91 patients were evaluated, from which
22 were excluded (19 patients not meeting inclusion cri-
teria and 3 patients had needle phobia). A total of
69patients (23 men, 46 women, aged 18–60 years), diag-
nosed with CGH by an experienced neurologist, were fi-
nally included and referred to the Physiotherapy Clinic of
Rouhani Hospital in Babol. During the study period, five
patients were lost to follow-up (Figure 1). All partici-
pants were diagnosed according to Sjaastad and
Fredriksen criteria [7]: (1) unilateral pain without side
shift starting in the neck and radiating to the
Dry Needling in Cervicogenic Headache
Figure 1. Flow-diagram of study recruitment and follow up.
frontotemporal region, (2) pain that is exacerbated by
neck movements, (3) restricted cervical range of motion,
and (4) tenderness in at least one of the joints of the up-
per cervical spine (C1–C3). Participants should exhibit
headache attacks from at least once a week over a period
greater than three months. In addition, patients should
exhibit active TrPs within the suboccipital, upper trape-
zius or sternocleidomastoid muscles, ipsi-laterally over
the symptomatic side reproducing their headache symp-
toms. The diagnosis of active TrPs was based on the ma-
jor criteria proposed by Simons et al. [22]: (1) presence of
a palpable taut band in a skeletal muscle; (2) presence of
a hypersensitive point in the taut band; (3) local twitch
response elicited by the snapping palpation of the taut
band; (4) reproduction of the referred pain in response to
compression; and (5) patient recognition of the referred
pain as a familiar symptom. If the first four criteria were
met, the TrP was considered latent. If all of the aforemen-
tioned criteria were present, the TrP was considered ac-
tive. Exclusion criteria included: cervical radiculopathy,
history of neck, shoulder trauma or surgery, history of
PT intervention in the neck and shoulder region in the
previous 6 months, diagnosed of primary or other sec-
ondary headaches, or needle phobia. Participants re-
ceived an MRI scan of the cervical spine to rule out disc
herniation. Participants provided their written informed
consent before participating in the study.
581
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Outcome Measures
A series of measures related to headache and physical
tests of the cervical spine were obtained at baseline, im-
mediately after, and 1, 3, and 6 months after the inter-
vention by the same therapist, who was blinded to the
intervention group. Among the primary outcomes in-
cluded in the trial registry, as a trial modification, head-
ache intensity and frequency were selected as the primary
outcomes for the study. Secondary outcomes included re-
lated- disability, performance of the deep neck flexor
muscles and cervical range of motion.
A numerical pain rating sale (NPRS) was used to as-
sess average headache intensity. Headache frequency was
recorded as the number of headache days in the past
week. Related-disability was measured using the Iranian
version of the Neck Disability Index (NDI) which has
been translated and validated into Persian [33]. The NDI
had excellent reliability and construct validity in patients
with CGH [34]. The NDI is a self-report questionnaire
with 10-items scored from 0 (no disability) to 5 (com-
plete disability). The numeric responses for each item are
summed for a total score ranging from 0 to 50 points
[35]. Scores are interpreted as follows: none (0–4 points),
mild (5–14 points), moderate (15–24 points), severe (25–
34 points), complete disability (34 or more) [36]. Young
et al. found that the minimal clinically important
582
difference (MCID) of the NPRS and the NDI for patients
with CGH was 2.5 and 5.5 points, respectively [34].
The performance of the deep neck flexor muscles,
which are essential for the stability and control of the cer-
vical region, was measured by the craniocervical flexion
test (CCFT) [37]. This test was performed in supine, with
the hip and knees at 45 flexion. The head and neck were
placed in a neutral and comfortable position. An air-
filled pressure sensor (Pressure Biofeedback Unit,
Chattanooga Group, Hixon, TN) was placed behind the
neck of the patient and inflated to a pressure of
20 mmHg [38]. Patients were instructed to slowly nod
their head and try to hold the target pressures of 22, 24,
26, 28, and 30 mmHg for 10 seconds with visual feed-
back. Each stage of the CCFT has been associated with
an increase in electromyography amplitude in the deep
cervical flexor muscles [39]. A rest period of 10 seconds
was allowed between holds. The maximum pressure
above baseline, which was achieved and held in a steady
manner correctly and without substitution movements,
was defined as the activation score and recorded. Before
performing the test, the correct movement and preven-
tion of substitution movements (e.g., palpable activity of
the superficial flexors or neck retraction) was taught.
This substitution was evident through visual observation
and palpation of the sternocleidomastoid muscle as it
contracted [39, 40]. The CCFT has shown high reliability
and construct validity supporting its use in the clinical
evaluation of patients with neck pain [41].
Measurements of active cervical range of motion
(CROM) into flexion, extension, left and right rotation
were made with universal goniometer [42, 43]. This de-
vice has excellent intra- and interrater reliability for
CROM assessment [42–45]. A systematic review with
meta-regression analysis indicated that no significant dif-
ferences in intra-rater and inter-rater reliability were ob-
served between expensive and inexpensive neck range of
motion devices [46]. In the current study, participants
were seated on an adjustable stool with both hips and
knees at 90 , feet positioned, shoulder width apart, with
their arms relaxed on the armrest and viewing a point at
eye level during the test. The thorax was tightly fixed by
a strap at spine level of the scapula. Patients were asked
to move their head and neck as far as possible in the di-
rection being measured, and measurement was taken for
each direction.
Randomization Procedure and Blinding
Prior to starting the trial, a collaborator not involved in
data collection created a randomization list (ratio 1:1)
created by a randomization program. Patients were ran-
domized into three groups (dry needling, sham needling,
PT) using sealed envelopes via a blind independent re-
searcher. In the sham needling group, patients were not
aware of the fact that they will not receive real dry nee-
dling. In addition, the assessor and therapist were two
Mousavi-Khatir et al.
different individuals and the assessor was blinded to the
intervention and statistical analysis was conducted by an
external researcher who was blinded to the group
allocation.
Interventions
All participants received 15 sessions (three times/week)
of PT consisting of transcutaneous electrical nerve stimu-
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lation (TENS) (20 minutes), infrared (10 minutes), and
ultrasound (5 minutes, 1 MHz) in the cervical spine [47],
as well as neck exercise program including craniocervical
flexion [15, 19].
In the dry needling group, patients also received DN
for four sessions (2nd, 5th, 8th, and 12th sessions) over
the active TrPs in the upper trapezius, suboccipital, and
sternocleidomastoid muscles (ipsi-lateral to the symp-
toms) by a physiotherapist with 13 years of experience
with this treatment. For upper trapezius and suboccipital
dry needling, patients were placed in prone position and
for the sternocleidomastoid dry needling, patients were
placed in supine position. The skin was first disinfected
with a cotton soaked in alcohol 60%, then DN was per-
formed with a 0.25  30 mm needle (DongBang
Acuprime, Korean) with a guiding tube. The therapist
inserted the needle perpendicular to the skin into the ac-
tive TrPs until a first local twitch response was provoked.
Needling of active TrP elicits a brief contraction of the
taut band followed by relaxation of the fibers (local
twitch response). The needle was moved to the muscle
TrP until local twitch response were extinct (which usu-
ally lasted between 60 and 90 seconds).
In the sham needling group, the needling intervention
was performed superficially at a point away from the ac-
tive TrP during the 4 sessions in the same muscles than
the real DN group. The procedure was the same than in
the real DN group but without eliciting local twitch
responses due to the superficial application of the inter-
vention. Patients were unaware if they received real or
sham dry needling.
We applied DN in a pragmatic approach where only
those active TrPs reproducing the headache symptoms on
each patient and at each treatment session were needled.
Sample Size Determination
Although multiple outcomes were considered, only head-
ache intensity outcome was powered because availability
of MCID data on this outcome for this population [34].
Therefore, sample size calculations were based on detect
a between-group difference of 2.5 units on headache in-
tensity (MCID) [34], assuming a standard deviation of
2.0, a repeated measure analysis of variance (ANOVA), a
P values < .05 and a desired power (b) of 80%. The esti-
mated desired sample size was at least 21 subjects per
group. We anticipated a potential dropout rate of 10%.
Therefore, 23 participants were required for each group.
Dry Needling in Cervicogenic Headache 583

Statistical Analysis Results

The SPSS software version 18.0 was used for data analy-
sis. Descriptive statistics were presented as means 6 stan-
dard deviations for ordinal data and frequency
percentage for nominal data. Before analyzing the data,
necessary assumptions for using repeated measures statis-
tical model were confirmed. In all variables, the Mauchly
sphericity test was not significant at a .05 level, Levin test
was used to determine the homogeneity of outcomes. The
Demographic and baseline characteristics of the patients
are summarized in Table 1. There were no missing data.
All groups were comparable at baseline. No adverse
events different from post-needling soreness in the dry
needling group (40%) were observed. Post-needling sore-
ness was limited to 48–72 hours after treatment and dis-
appeared without any further treatment.

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results showed that assumption of homogeneity of out-
comes was confirmed. The results of Mbox test revealed
that covariates were homogeneous; therefore, repeated
measures ANOVA was applicable.
For comparison of baseline characteristics between
groups, one-way ANOVA was applied. To evaluate the
effects of interventions on primary outcomes, 5x3 re-
peated measured ANOVA with time (baseline, post-
treatment and 1, 3, 6 months) as the within-subjects fac-
tor and group (dry needling, sham needling, control) as
between-subjects factor were separately applied on head-
ache intensity and headache frequency. Similarly, 5  3
repeated measured ANOVA with time (baseline, post-
treatment and 1, 3, 6 months) as the within-subjects fac-
tor and group (dry needling, sham needling, control PT)
as the between-subjects factor was used for each second-
ary outcome. When a significant effect was observed,
post hoc analyses were conducted with the Bonferroni
test. The effect size was calculated when the Partial Eta
Squared (g2p) was significant. A Partial Eta Squared of
0.01 was considered small, 0.06 medium, and 0.14 large
[48]. The hypothesis of interest was the group*time inter-
action with a Bonferroni-corrected P values <.01 due to
the multiple (five) outcome measures.
Headache Intensity and Frequency
The repeated measures ANOVA revealed significant
Group*Time interaction for the intensity (F2,63¼10.89,
P < .001, g2p: 0.263) of headaches (Table 2): patients
receiving DN and PT showed higher decreases in head-
ache intensity at all follow-up periods when compared
with sham needling (between-groups differences, post-
treatment: D 1.4, 95% CI 2.0 to 0.9; 1 month: D
1.6, 95% CI 2.2 to 0.9; 3 months: D 1.9, 95% CI
2.5 to 1.4; 6 months: D 1.8, 95% CI 2.5 to 1.1)
and with PT alone (between-groups differences, post-
treatment: D 1.4, 95% CI 1.9 to 1.0; 1 month: D
1.4, 95% CI 1.9 to 0.9; 3 months: D 2.2, 95% CI
2.6 to 1.8; 6 months: D 2.2, 95% CI 2.8 to 1.6).
The Group*Time interaction for the frequency of head-
aches (F2,63¼ 2.65, P ¼ .048, g2p: 0.008) did not reach
the statistical significance due to the correction for multi-
ple comparisons, although patients receiving DN and PT
also exhibited higher decreases in headache frequency at
all follow-ups when compared with sham needling (be-
tween-groups differences, post-treatment: D 0.9, 95%
CI 1.2 to 0.6; 1 month: D 1.0, 95% CI 1.6 to
0.4; 3 months: D -1.4, 95% CI 1.8 to 1.0; 6 months:
D 1.1, 95% CI 1.7 to 0.5) and with PT alone (be-
tween-groups differences, post-treatment: D 0.6, 95%
CI 1.0 to 0.2; 1 month: D 1.2, 95% CI 1.6 to
0.8; 3 months: D 1.4, 95% CI 1.9 to 0.9; 6

Table 1. Baseline demographics and measurements

Characteristics DN (n ¼ 23) Sham DN (n ¼ 23) Physical Therapy (n ¼ 23) P-value

Sex female n (%) male n 16 (70%) 7 (30%) 15 (65%) 8 (35%) 15 (65%) 8 (35%) .947
(%)
Age (years) 36.7 6 9.7 39.3 6 9.6 36.6 6 9.3 .623
BMI (kg/m2) 23.5 6 3.1 24.8 6 3.8 25.2 6 2.3 .185
History of headache (years) 4.8 6 3 4.4 6 2.7 5.2 6 2.2 .766
Affected side (right/left) 14/9 15/8 13/10 .664
Headache intensity (NPRS, 8.1 6 1.3 7.2 6 1.6 7.6 6 1.3 .522
0–10)
Headache frequency (days/ 4.4 6 1.4 4.2 6 1.3 4.8 6 1.3 .513
week)
CCFT (mmHg) 23.3 6 1.4 23.4 6 1.4 23.8 6 1.4 .613
NDI (0–50) 32.0 6 4.0 31.4 6 5.4 33.6 6 5.2 .772
Cervical flexion ( ) 52.3 6 4.1 54.1 6 5.2 53.8 6 5.3 .533
Cervical extension ( ) 42.7 6 4.1 44.05 6 4.8 45.1 6 4.5 .481
Cervical rotation to the af- 55.5 6 5.4 57.2 6 5.9 56.4 6 6.1 .684
fected side ( )
Cervical rotation to the un- 59.1 6 5.1 60.2 6 5.3 61.1 6 5.1 .326
affected side ( )

DN ¼ Dry Needling; BMI ¼ Body Mass Index; NPRS ¼ Numerical Pain Rate Scale; NDI ¼ Neck Disability Index; CCFT ¼ Craniocervical flexion test.
584 Mousavi-Khatir et al.

Table 2. Results of analysis of variance with repeated measures for each outcome

Outcome Effect Type Mean Square F Sig. Partial Eta Squared

Headache intensity Time 593.92 740.38 <.001 0.924
Group 77.097 22.52 <.001 0.425
Time*Group 8.73 10.89 <.001 0.263
Headache frequency Time 244.51 230.21 <.001 0.791
Group 30.91 11.19 <.001 0.268
Time*Group 2.82 2.65 .048 0.008
Craniocervical flexion test Time 275.63 316.48 <.001 0.838

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Group 19.22 3.25 .045 0.096
Time*Group 6.10 7.01 <.001 0.187
Neck disability index Time 5129.47 781.13 <.001 0.922
Group 867.22 11.19 <.001 0.269
Time*Group 57.117 14.41 <.001 0.321
Cervical flexion Time 2184.35 157.93 <.001 0.718
Group 555.79 6.27 .003 0.168
Time*Group 206.43 14.92 <.001 0.325
Cervical extension Time 3164.32 248.87 <.001 0.623
Group 685.65 12.23 <.001 0.210
Time*Group 106.39 17.89 <.001 0.423
Cervical rotation to the affected side Time 3463.20 263.23 <.001 0.809
Group 2773.21 41.26 <.001 0.571
Time*Group 660.95 50.23 <.001 0.618
Cervical rotation to the unaffected side Time 1825.84 120.26 <.001 0.660
Group 3024.30 52.55 <.001 0.629
Time*Group 695.80 45.83 <.001 0.597

months: D 1.0, 95% CI 1.7 to 0.3, Table 3). No
significant differences between sham needling plus phys-
iotherapy and PT alone groups were observed (Figure 2).
Secondary Outcomes
The Group*Time interaction was also significant for
NDI (F2,63¼14.41, P < 0.001, g2p: 0.321, Table 2):
patients receiving DN showed a greater decrease in
related-disability in all follow-ups than those receiving
sham needling (post-treatment: D 3.1, 95% CI 5.5 to
1.7; 1 month: D 5.3, 95% CI 8.3 to 2.3; 3 months:
D 6.2, 95% CI 8.3 to 4.1; 6 months: D 6.6, 95%
CI 9.8 to 3.5) or physiotherapy alone (post-treatment:
D 4.3, 95% CI 6.5 to 2.2; 1 month: D 6.5, 95%
CI 9.5 to 3.5; 3 months: D 7.6, 95% CI 10.0 to
4.2; 6 months: D 7.6, 95% CI 11.0 to 4.2,
Table 3). No significant differences between sham nee-
dling and PT alone groups were observed (Figure 3).
The Group*Time interaction was also significant for
the CCFT (F2,63¼7.01, P < .001, g2p: 0.187) (Table 2)
showing that patients receiving DN exhibited higher
increases in CCFT post-treatment and 3 and 6 months af-
ter than those receiving sham needling or just PT
(Table 3, Figure 3).
Finally, the Group*Time interaction was also signifi-
cant for CROM in flexion (F2,63¼ 14.92, P < .001, g2p:
0.325), extension (F2,63¼17.89, P < .001, g2p: 0.423)
and rotation toward the affected (F2,63¼50.23,
P < 0.001, g2p: 0.618) and the unaffected (F2,63¼ 45.83,
P < 0.001, g2p: 0.597) sides (Table 2): patients who
received DN showed a higher increase in CROM at all
follow-up periods than those receiving sham needling
(between-groups differences ranging from 3.0 to 12.7 )
or PT alone (between-groups differences ranging from
4.1 to 13.2 ) (Table 3). No significant differences be-
tween sham needling and PT alone groups in CROM
were either found (Figure 4).
Discussion
Clinical Findings
The current triple-blind, randomized, controlled trial
showed that adding DN to a PT program significantly re-
duced in a greater extent headache intensity and fre-
quency and related-disability, and increased active
CROM than adding sham DN or just PT alone in CGH
patients with active TrPs in the cervical muscles up to
6 months after the intervention. Although some pilot
studies or single cases report have shown positive effects
of DN in patients with CGH [23, 24, 49, 50], the current
study is the first randomized clinical trial including a
sham group.
The data indicate that patients with CGH receiving
DN experienced statistically significant decreases (large
between-group effect size) in headache intensity as pri-
mary outcome at all follow-up periods when compared
to those receiving sham needling or PT alone; however, it
should be recognized that most differences did not reach
the 2.5 points score identified as MCID for this outcome
[34]. Similarly, patients receiving DN and PT also
Dry Needling in Cervicogenic Headache 585

Table 3. Baseline, post-treatment and follow-up scores of each outcome

Post 1-Month 3-months 6-months

Outcome Group Baseline Treatment Follow-Up Follow-Up Follow-Up
Headache intensity Dry needling Mean 8.1 1.8 1.3 0.8 1.2
SD 1.3 0.8 1.1 0.9 1.2
Sham needling Mean 7.2 3.2 2.9 2.8 3.0
SD 1.6 1.0 1.0 1.1 1.1
Physical therapy Mean 7.6 3.2 2.7 3.0 3.4
SD 1.3 1.0 0.6 0.7 0.7

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Headache frequency Dry needling Mean 4.4 1.5 0.9 0.7 0.9
SD 1.4 0.7 0.8 0.7 0.8
Sham needling Mean 4.2 2.4 1.9 2.1 2.0
SD 1.3 0.8 1.1 0.8 1.0
Physical therapy Mean 4.8 2.1 2.2 2.3 2.0
SD 1.3 0.8 0.8 0.8 1.0
Craniocervical flexion test Dry needling Mean 23.3 27.9 27.4 27.3 27.5
SD 1.4 1.4 1.2 1.0 1.2
Sham needling Mean 23.4 27.4 26.9 26.2 25.9
SD 1.4 1.8 1.8 1.5 2.0
Physical therapy Mean 23.8 25.9 26.6 26.7 26.6
SD 1.4 1.5 1.5 1.5 1.7
Neck disability index Dry needling Mean 32.0 9.1 7.7 6.5 6.3
SD 4.0 2.4 2.4 3.6 4.8
Sham needling Mean 31.4 12.2 13.0 12.7 12.9
SD 5.4 3.7 4.7 4.5 5.2
Physical therapy Mean 33.6 13.5 14.2 14.1 13.9
SD 5.2 4.6 5.35 5.1 5.8
Cervical flexion Dry needling Mean 52.3 68.3 69.2 68.6 67.1
SD 4.2 4.5 3.2 3.9 4.1
Sham needling Mean 54.1 65.5 63.1 62.3 61.8
SD 5.2 5.2 6.1 5.9 5.5
Physical therapy Mean 53.8 64.3 63.7 61.6 62.0
SD 5.3 5.5 5.7 6.1 5.6
Cervical extension Dry needling Mean 42.7 58.4 57.8 58.7 59.2
SD 4.1 2.95 3.6 4.3 3.3
Sham needling Mean 44.0 53.7 51.7 52.5 50.3
SD 4.8 4.8 5.6 5.6 5.2
Physical therapy Mean 45.1 52.6 51.7 52.1 51.3
SD 4.5 3.8 4.3 4.0 4.6
Cervical rotation to the affected side Dry needling Mean 55.5 76.2 76.4 76.3 77.0
SD 5.4 5.0 4.8 3.7 3.3
Sham needling Mean 57.2 66.2 66.4 65.1 64.3
SD 5.9 3.9 3.7 3.9 4.4
Physical therapy Mean 56.4 66.1 65.4 64.6 63.8
SD 6.1 4.1 4.8 4.1 4.4
Cervical rotation to the unaffected side Dry needling Mean 59.1 76.8 76.1 77.3 77.8
SD 5.1 4.5 4.1 3.5 4.2
Sham needling Mean 60.2 66.1 65.8 63.7 64.8
SD 5.3 4.9 3.8 4.12 4.1
Physical therapy Mean 61.1 65.8 64.4 65.3 64.2
SD 5.1 3.5 4.4 3.7 4.7

showed a significant reduction in pain-related disability, trapezius, sternocleidomastoid or suboccipital muscles

as assessed by the NDI, reporting between-groups differ-
ences closed to 5.5 points identified as MCID for this
outcome [34]. Nevertheless, it should be also noted that
the lower bound of the confidence intervals were lower
than the MCID, limiting the clinical effects of these
changes in some patients.
It has been hypothesized that TrPs can represent a
source of peripheral pain in patients with headaches [48].
Active TrPs in the cervical musculature, e.g., upper
can refer pain to the head and contribute to CGH [32,
51, 52]. Therefore, examination and therapeutic inter-
ventions emphasizing muscle dysfunction may be effec-
tive for the management of patients with CGH [23, 24,
32, 51, 52]. In fact, a Delphi study including eleven inter-
national experts on headache proposed the assessment of
TrPs as one important element of the clinical examina-
tion of individuals with headaches [53]. However, it
should be considered that not all patients with CGH will
586 Mousavi-Khatir et al.

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Figure 2. Change in mean value at each measurement time-point (A), headache intensity (numerical pain rating sale) (B), headache
frequency (days/week). Data are means and error bars are standard deviation (SD). *P<.001 for between-group differences be-
tween the dry needling group with sham needling and control (physical therapy) groups.

Figure 3. Change in mean value at each measurement time-point (A), related-disability, neck disability index (0–50) (B) cranio-cervi-
cal Flexion Test. Data are means and error bars are standard deviation (SD). *P<.001 for between-group differences between the
dry needling group with sham needling and control (physical therapy) groups.

Figure 4. Change in mean value of cervical range of motion at each measurement time-point (A), Cervical Flexion (B), Cervical
Extension (C), Cervical Rotation to affected side (D), Cervical Rotation to the unaffected side. Data are means and error bars are
standard deviation (SD). *P<.001 for between-group differences between the dry needling group with sham needling and control
(physical therapy) group.
Dry Needling in Cervicogenic Headache
display active TrPs; therefore, not all patients with CGH
will benefit from DN.
Current understanding of the neurophysiological
mechanisms of DN proposes a combination of peripheral
and central effects including a reduction of nociceptive
peripheral driving (the TrP), a modulation spinal effect in
the dorsal horn, and an activation of central inhibitory
pain pathways [30, 31]. These mechanisms would ex-
plain the reduction in headache intensity observed when
adding DN to a PT program in patients with CGH.
Nevertheless, other factors including a potential placebo
effect, previous experience or patient’s expectations
could be also involved in dry needling mechanisms.
Unfortunately, we did not collect data on these outcomes
in our trial.
Motor Findings
Since TrPs can be also associated with motor disturban-
ces [22], we also analyzed changes in the CCFT and cer-
vical range of motion. Reduced performance of the
CCFT has been found in patients with CGH [54].
Additionally, it has been reported that the presence of ac-
tive TrPs in the neck muscles determines an altered acti-
vation of superficial neck muscles during the CCFT in
women with migraine [55].
We observed an increase in the performance of the
CCFT in all groups, with statistically, but small, greater
improvements in the DN group. This improvement in all
groups could be related to the fact that all patients re-
ceived an exercise program including training of the cra-
niocervical musculature; however, adding DN to this
approach lead to greater improvements in performance
of the CCFT. An impaired performance of the CCFT sug-
gests an altered pattern in the cervical spine flexor syn-
ergy, associated with a lower activation of the deep neck
flexors and a potential overactivity of the sternocleido-
mastoid muscle, pattern which could promote TrP acti-
vation and referred pain to the head [55]. Current
findings would suggest that although reducing pain and
paying attention to deep neck flexor muscle exercises in
patients with CGH could improve CCFT performance,
paying attention to active TrPs of superficial neck muscu-
lature and reducing their hyperactivity could be more ef-
fective for improving this motor deficit.
Finally, the inclusion of DN also improved CROM in
flexion, extension, and rotation up to six months after
treatment. Restricted range of motion has been shown to
discriminate CGH from other headaches such as TTH or
migraine [56]. Park et al reported an increased tone and
stiffness of the suboccipital musculature and upper trape-
zius muscle in patients with CGH as compared to healthy
controls [57]. Since TrPs are associated with an increased
muscle stiffness, it is possible that the decrease in tone in-
duced by the application of DN lead to the increase in
cervical range of motion. Our results agree with those
previously reported by Sedighi et al. [23] who also found
587
an improved cervical flexion and rotation range of mo-
tion after the application of DN in suboccipital and up-
per trapezius muscles in CGH patients. Hodges stated
that pain changes the biomechanical behavior by modify-
ing stiffness to prevent further pain or injury [58].
Nevertheless, we need to recognize that between-groups
differences were relatively small to be considered as clini-
cally relevant. Future studies should investigate the asso-
ciation between the application of DN and potential
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changes in motor function and range of motion in indi-
viduals with headaches.
Strengths and Limitation
The results of this trial should be considered according to
its potential strengths and limitations. Strengths included
the application of a sham needling intervention and a
multimodal PT approach. Among the limitations, multi-
center studies controlling for site and therapist effects in
subsequent trials might enhance the generalizability of
our results. Second, we included individuals with CGH
who presented active TrPs in the neck muscles; hence, the
results cannot be generalized to all CGH patients. In ad-
dition, we did not assess the evolution of the active TrPs
throughout the study. Future studies investigating the
effects of DN could also evaluate if the active TrPs re-
solved with repeated treatment sessions, and, if such res-
olution would occur, if an association with symptoms
reduction would be observed. Third, we did not consider
the role of psychological variables, for example, mood
disorders or sleep disturbances. Fourth, CGH patients al-
located to the DN group received four sessions based on
the author clinical experience since no available data
exists on the frequency and dose of DN. We do not know
if a greater number of sessions would reveal differences
between interventions.
A final point to consider is the use of Sjaastad and
Fredriksen criteria [7] instead of the International
Classification of Headache Disorders (ICHD-3) diagnos-
tic criteria for CGH [5]. This decision was mainly based
on the ability to make the CGH diagnosis without the
use of imaging or anesthetic blockade as needed by the
ICHD-3 (5). Although the reliability and validity of these
criteria have been established [59–61], the ICHD-3 must
be acknowledged and considered in trials involving
patients with CGH. Therefore, the results of the current
trial should be considered for patients with CGH diag-
nosed with the Sjaastad and Fredriksen criteria [7]
Conclusion
The current triple-blind controlled clinical trial showed
that adding DN to a PT program had a positive effect on
headache intensity, headache frequency, related-
disability, performance of the CCFT and cervical active
range of motion in patients with CGH presenting with
active TrPs in the, suboccipital, upper trapezius and
588
sternocleidomastoid muscles. Nevertheless, the observed
changes did not reach the clinical relevance when com-
pared to sham needling or an absence of needling
intervention.
Ethic Approval and Patient Consent
Iran. The study protocol was approved by the Research
Ethics Committee of the Babol University of Medical
Sciences (code 1397.071). Participants provided their
written informed consent before participating in the
study.
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