Effects of a Physical Therapy Protocol in Patients with

Chronic Migraine and Temporomandibular Disorders:

A Randomized, Single-Blinded, Clinical Trial

Miriam Garrigós-Pedrón, PT-PhD Aims: To investigate the effects of adding orofacial treatment to cervical physical
Professor therapy in patients with chronic migraine and temporomandibular disorders (TMD).
Departmento de Fisioterapia Methods: A total of 45 participants with chronic migraine and TMD aged 18 to
Motion in Brains Research Group,
Institute of Neuroscience and Sciences 65 years were randomized into two groups: a cervical group (CG) and a cervical
of the Movement (INCIMOV) and orofacial group (COG). Both groups continued their medication regimens
Centro Superior de Estudios for migraine treatment and received physical therapy. The CG received physical
Universitarios La Salle therapy only in the cervical region, and the COG received physical therapy in both
Universidad Autónoma de Madrid the cervical and orofacial regions. Both groups received six sessions of treatment
Madrid, Spain
that consisted of manual therapy and therapeutic exercise in the cervical region or
Roy La Touche, PT-PhD the cervical and orofacial regions. Scores on the Craniofacial Pain and Disability
Professor Inventory (CF-PDI) and the Headache Impact Test (HIT-6) were primary outcome
Departmento de Fisioterapia
Motion in Brains Research Group variables, and the secondary outcome variables were scores on the Tampa Scale
Institute of Neuroscience and Sciences for Kinesiophobia (TSK-11), pain intensity measured on a visual analog scale
of the Movement (INCIMOV) (VAS), pressure pain thresholds (PPTs) in the temporal, masseter (2 points, M1
Centro Superior de Estudios and M2) and extratrigeminal (wrist) regions, and maximal mouth opening (MMO).
Universitarios La Salle; Data were recorded at baseline, posttreatment, and after 12 weeks of follow-
Universidad Autónoma de Madrid;
Institute of Neuroscience and up. The α level was set at .05 for all tests and two-way repeated-measures
Craniofacial Pain (INDCRAN) analysis of variance (ANOVA) for within- and between-group interactions.
Institute of Health Research of the Results: There were 22 CG participants (13.6% men and 86.4% women) and
University Hospital La Paz (IdiPAZ) 23 COG participants (13% men and 87% women). The ANOVA analysis revealed
Madrid, Spain statistically significant differences for group × time interaction in CF-PDI, HIT-6
Pablo Navarro-Desentre, PT in the last follow-up, pain intensity, PPTs in the trigeminal region, and MMO
Physiotherapist (P < .05), with a medium-large magnitude of effect. No statistically significant
Fisioterapia Coral Mustienes differences were found in the PPTs of the extratrigeminal region or in the TSK-11
Pedrola, Zaragoza, Spain
(P > .05). Conclusion: Both groups reported a significant improvement in CF-PDI,
Manuel Gracia-Naya, MD HIT-6, and pain intensity. Cervical and orofacial treatment was more effective
Doctor than cervical treatment alone for increasing PPTs in the trigeminal region and
Department of Neurology
Hospital Universitario Miguel Servet producing pain-free MMO. Physical therapy alone was not effective for increasing
Zaragoza, Spain the PPTs in the extratrigeminal region (wrist) or decreasing the level of TSK-11.
J Oral Facial Pain Headache 2018;32:137–150. doi: 10.11607/ofph.1912
Eva Segura-Ortí, PT-PhD
Professor
Department of Physiotherapy Keywords: manual therapy, migraine, physical therapy, temporomandibular
Universidad Cardenal Herrera-CEU disorders, therapeutic exercise
CEU Universities

T
Valencia, Spain emporomandibular disorders (TMD) and chronic migraine are
common and important public health care concerns.1–5 Patients
Correspondence to:
Dra Miriam Garrigós-Pedrón presenting both disorders have reduced health-related quality of
Departamento de Fisioterapia life (HRQoL) and severe disabilities that result in a significant economic
Centro Superior de Estudios burden and affect not only the individuals, but also their families and
Universitarios La Salle society.6,7
Universidad Autónoma de Madrid The association between migraine and TMD has been demonstrat-
C/ La Salle, 10, 28023 Madrid, Spain
Email: [email protected] ed in various studies.8,9 These disorders present similar signs, symp-
toms, and pain mechanisms, including cutaneous allodynia and the
Clinical Trials Register: NCT02627014. sensitization of neurons in the trigeminocervical complex.9–14 Previous
studies have demonstrated that TMD is a risk factor for increased head-
©2018 by Quintessence Publishing Co Inc. ache frequency and migraine chronification.8,15 It has been suggested
that these conditions are separate problems that might aggravate or
sustain each other.16
Treatment of migraine can be more complicated when the patients
present with comorbidities compared to those who do not. In clinical

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Garrigós-Pedrón et al

practice, when migraine and TMD occur in the same ized in headaches and based on the criteria of the
person, each disorder is treated separately. In a re- International Classification Headache Disorders-III
cent study in women with migraine and TMD, the of the International Headache Society;29 (2) age be-
migraine improved when the two conditions were tween 18 and 65 years; and (3) presence of myo-
treated with medication and a stabilization splint. fascial TMD according to the Research Diagnostic
Additionally, better results were obtained when com- Criteria for TMD (RDC/TMD).11
bined therapy was applied, which was better than Participants were excluded if they presented with
pharmacologic treatment only, stabilization splints any of the following conditions: TMD due to disc dis-
only, or placebo treatment.17 placement, osteoarthritis, or inflammatory arthritis
Physical therapy addressing the cervical region of the temporomandibular joint (TMJ); other chronic
has demonstrated beneficial effects for patients with diseases (respiratory, cardiovascular, and muscu-
migraine. Several reviews of manual therapy for mi- loskeletal disorders such as chronic polyarthritis,
graine have suggested that combined modalities of rheumatic muscular inflammation, osteoporosis, and
physical therapy—such as massage, myofascial re- osteoarthritis); other headaches, neurologic diseas-
lease, trigger point treatment, stretching, mobilization, es, or dental problems; cognitive, emotional, or psy-
and manipulation techniques—provide significant im- chological disturbances; previous surgery or trauma
provements in headache intensity and frequency.18–21 in the orofacial region; and orthodontic or physical
Therapeutic exercise has also been demonstrated therapy treatment in the last 6 months. The intended
to be beneficial for patients with migraine, given it sample size was 52 participants; however, the final
results in reduction of pain intensity and frequency, sample was 45, as 7 participants were lost to the
drug use, and improvement of HRQoL.22 study for different reasons.
Manual therapy and therapeutic exercises in pa- After consenting, the participants were random-
tients with TMD result in decreased pain and increased ized using a randomized computer program (random-
pain-free maximal mouth opening (MMO).23–25 A previ- ization.com), grouped according to age and sex, and
ous study showed that manual therapy and therapeutic assigned by a study member who was not involved
exercise in the cervical region in patients with myofas- in the participant’s assessment or treatment to either
cial TMD resulted in reduced facial pain, increased the cervical group (CG) or the cervical and orofa-
pressure pain thresholds (PPTs) in the masticatory cial group (COG). The assessor was blinded to the
muscle, and increased pain-free MMO.26 subject’s group assignments, and the participants
It has been suggested that if TMD can influence were asked not to make any comments about their
headache, TMD treatment could be used to help re- treatment.
duce headache.27,28 In various studies, physical ther-
apy in the cervical and orofacial regions decreased Study Design
headache intensity in patients presenting both cer- The study was conducted as a randomized clinical
vicogenic headache and TMD when compared to trial. The sample consisted of two groups of par-
a control group that received only treatment in the ticipants diagnosed with chronic migraine and myo­
cervical region.27,28 There is a lack of information on fascial TMD. The CG received treatment only in the
manual therapy and therapeutic exercise on the com- cervical region, and the COG received treatment
bined orofacial and cervical regions for management in both the cervical and orofacial regions. All the
of migraine and TMD; thus, it is important to evalu- procedures used in the study followed the ethical
ate the effects of physical therapy in these regions in guidelines of the Declaration of Helsinki and were
patients with chronic migraine and TMD. Therefore, approved by the local ethics committee of the
the aim of this study was to investigate the effects of HUMS in Zaragoza, Spain, and Ethics Committee
adding orofacial treatment to cervical physical thera- for Clinical Research of Aragon, Spain (approv-
py in patients with chronic migraine and TMD. al date 18/02/2015). The study adhered to the
CONSORT statement. All the participants provided
written informed consent. The study is registered in
Materials and Methods ClinicalTrials.gov with the identifier: NCT02627014.

Participants Interventions
The participants were recruited between July 2015 Both groups received a total of six sessions of treat-
and March 2016 after specialized headache consul- ments delivered within a 3- to 6-week period. The
tations in the Neurology Department of the Hospital duration of each treatment session was 30 minutes.
Universitario Miguel Servet (HUMS). The inclusion The parameters for session distribution and the du-
criteria consisted of three main parameters: (1) diag- ration of each treatment session were in accordance
nosis of chronic migraine by a neurologist special- with other studies.27,28,30 Both groups had a similar

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 Garrigós-Pedrón et al

Techniques:

Technique 1 Technique 2

Suboccipital Cervical joint passive mobilization in

muscle inhibition supine and prone positions

Exercises 1 to 4: Co-contraction of flexors and extensors, increasing the difficulty and resistance by using a latex band in the last exercise

Exercise 1 Exercise 2 Exercise 3

Exercise 4 Exercise 5: Nerve tissue techniques

Fig 1  Techniques and exercises used in the cervical group.

distribution of treatment intervals. The treatment cise. In addition, these participants received self-care
techniques were applied by the same physiotherapist tips: (1) be aware of the position of the head during
(P.N.D.), who had more than 3 years of clinical experi- the day; (2) avoid working with the head tilted; and (3)
ence in craniofacial techniques. This physiotherapist maintain good cervical ergonomics. Exercises to be
also received specific training for the study treatment. performed at home were explained and practiced in
All the participants received a handout with exercises consultation with the physiotherapist and performed
to be performed daily, which were explained in detail once a day for 5 days per week.
with images and a series of self-care techniques.
COG Intervention
CG Intervention Participants in this group underwent cervical treat-
Participants in the CG received treatment only in ment and also received an additional intervention
the cervical region.28 In these sessions, participants in the orofacial region.27,28 Participants were taught
were taught how to perform each exercise, and all the each exercise, and all the details of the training
details of the training program were explained (sets, program were explained (sets, repetitions, rest pe-
repetitions, rest periods, frequency, and common riods, frequency, and common mistakes). The ad-
mistakes for each of the exercises). Treatment in this ditional treatment included several techniques,
group combined manual therapy and both therapeutic shown in Fig 2: (1) longitudinal caudal bilateral tech-
and home exercises. Treatment consisted of several nique in the TMJ (Technique 1);32 (2) neuromuscu-
techniques, shown in Fig 1: (1) suboccipital muscle lar technique in the masseter and frontal muscles
inhibition (Technique 1); (2) cervical joint passive mo- (Techniques 2 and 3);33 and (3) coordination exercise
bilization in supine and prone positions (Technique of the masticatory muscles, increasing the difficulty
2); (3) co-contraction of flexors and extensors, in- and resistance (Exercises 1A–1E) with nerve tissue
creasing the difficulty and resistance by using a la- techniques (Exercise 2).23 Participants performed
tex band (Thera-Band, Resistive Exercise Systems; three sets of 10 repetitions for each exercise. In ad-
Hygenic Corporation) (Exercises 1–4);31 and (4) dition, these participants received several self-care
nerve tissue techniques (Exercise 5). Participants tips: (1) avoid eating hard foods; (2) avoid maximum
performed three sets of 10 repetitions for each exer- mouth opening; (3) no chewing gum; (4) no sleeping

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Garrigós-Pedrón et al

Techniques:
Technique 1 Technique 2 Technique 3

Longitudinal caudal
bilateral technique in TMJ Neuromuscular technique in Neuromuscular technique in frontal muscle
masseter muscle

Exercises 1a to 1e: Coordination exercises of masticatory muscles, increasing the difficulty and resistance

Exercise 1a Exercise 1b Exercise 1c Exercise 1d Exercise 1e

Exercise 2: Nerve tissue techniques

Fig 2  Techniques and exercises that were added to the cervical and were utilized in the cervical and orofacial group.
TMJ = temporomandibular joint.

on the affected side; (5) yawning with the tongue in included a sociodemographic questionnaire that col-
the upper incisors; and (6) keep the tongue in the lected information regarding age, sex, height, weight,
upper incisors. Home exercises were explained and duration of the pain, educational level, and work sta-
practiced in consultation with the physiotherapist and tus. Data on pain-related disability in the cranioman-
performed once a day for 5 days per week. dibular and facial regions were collected using the
Craniofacial Pain and Disability Inventory (CF-PDI).34
Procedure The impact and severity of headache were quantified
During the study period, both groups continued their using the Spanish version of the Headache Impact
medication regimens in accordance with previous stud- Test (HIT-6),35,36 and the Spanish version of the Tampa
ies.20 For ethical reasons, the participants could not be Scale for Kinesiophobia (TSK-11) was used to assess
withdrawn from pharmacologic treatment during the the fear of pain and movement.37
study. All had a similar intake of routine medication con- Once the participants had completed all
sisting of continuous preventive treatment and abortive self-reports, the assessor proceeded to evaluate pain
pharmacologic treatment at the onset of migraine at- intensity with a visual analog scale (VAS), as well as
tacks prescribed by a headache specialist neurologist. PPTs and pain-free MMO. PPTs were measured bilat-
Medication intake was equivalent in both groups. erally over the trigeminal region with the stimulus ap-
A blinded investigator performed four assess- plied to the skin overlying the masseter and temporalis
ments of all measurements, which included baseline muscles and over the extratrigeminal region (wrist).
(pretreatment), posttreatment, 6 weeks after the final
treatment (follow-up 1), and 12 weeks after the final Primary Outcomes
treatment (follow-up 2). The CF-PDI was used to assess pain, disability,
On assessment days, participants completed sev- and functional status of the mandibular and cranio-
eral questionnaires. These included various self-re- facial regions. This self-administered questionnaire
ports for pain-related variables. The baseline measures is an objective tool for assessing pain and disability

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 Garrigós-Pedrón et al

in patients with craniofacial pain and consists of 21 point was established on the palmar region at the
items that indicate increasing levels of pain and dis- wrist in the middle point of the distal part between
ability in the craniofacial region, with a possible over- the ulnar and radius. Three measurements were tak-
all score ranging from 0 to 63.34 en by the same evaluator (M.G.P.) for each point,
The Spanish version of the HIT-6 was used to with an interval of 30 seconds between measure-
assess the impact and severity of headache on the ments. Bilateral data for each point were analyzed,
patient’s life.35,36 This questionnaire consists of six and no significant differences were found. The PPTs
items that assess headaches’ interference with daily corresponded to the mean of the three measures for
life and has demonstrated acceptable psychometric each point and the mean of both sides of the par-
properties.38 Furthermore, this instrument has been ticipant.46,47 During the measurements, the algometer
validated for patients with chronic migraine.39 The to- was held perpendicular to the skin, and the partici-
tal score can range from 36 to 78, and the results pant was told to immediately alert the assessor when
are stratified into four impact grades: (1) little or no the pressure produced pain.46,47 Previous research
impact (HIT-6 score 36–49); (2) moderate impact has shown a high reliability during this test (intraclass
(HIT-6 score 50–55); (3) important impact (HIT-6 correlation coefficient = 0.91; 95% confidence inter-
score 56–59); and (4) severe impact (HIT-6 score val [CI] 0.82 to 0.97).46,48
60–78). The minimally important difference in the The pain-free MMO was registered using a digital
HIT-6 scores in patients with chronic daily headache calibrated caliper placed between the edges of the
was estimated to be between 2.3 and 2.7.40,41 maxillary and mandibular incisors.17,49 Measurements
were made when the participant was seated with his/
Secondary Outcomes her back supported, with feet resting on the floor.49,50
The Spanish version of the TSK-11 was used to as- The instruction given to the participant was, “Open
sess fear of reinjury due to movement. This question- your mouth as wide as possible without causing
naire has an 11-item, 2-factor structure that includes pain or discomfort.”46,49 The vertical range of motion
activity avoidance and harm and demonstration of ac- corresponded to the last measurement of the three
ceptable psychometric properties.37 The total score opening movements made by the participant.17,49
can range from 11 to 44 points, and each item is rat-
ed on a 4-point Likert-type scale (1 = strongly dis- Sample
agree and 4 = strongly agree). High scores indicate The G* Power Software of the University of
greater fear of reinjury due to movement. Düsseldorf was used to calculate the correct sam-
The VAS was used to measure the intensity of ple size.51 Craniofacial disability was used as the
pain perceived by the participants.42 The VAS was main outcome variable. Considering an alpha error of
a 100-mm horizontal line anchored at one end with 0.05 and a statistical power of 80%, a minimum of
0, indicating no pain, and at the other end with 10, 22 participants was required to detect an effect size
indicating the worst pain imaginable. The participant of 0.27, taking into account the mean difference and
placed a mark along the line corresponding to the standard deviation (SD) of the result by using a pre-
intensity of their pain. This scale has been demon- and a postmeasurement in each group. To detect the
strated to be a reliable and valid measure of pain in- effects of size, data from a pilot study with six partic-
tensity and is sensitive to clinical changes in pain.43,44 ipants per group were used. Taking into account the
Changes of 1.1 to 1.2 cm indicate a minimal clinical possibility of a 20% loss, the sample size required for
improvement.45 this study was 52 participants (26 per group).
An analog algometer was used to assess PPTs
(Wagner Instruments). This instrument consists of a Statistical Analyses
1-cm diameter hard rubber tip attached to the plung- The Statistical Package for Social Sciences (SPSS
er of a pressure (force) gauge. The dial of the gauge 21, SPSS) software was used for the statistical analy-
is calibrated in kg/cm,2 and the range of the algome- sis. The normality of the variables was evaluated by the
ter is 0 to 10 kg with 0.1-kg increments. Kolmogorov-Smirnov Test. Descriptive statistics were
PPTs were measured at three intratrigeminal used to summarize the data for continuous variables
sites. One was applied to the skin overlying the an- and are presented as mean ± SD, 95% CI, and as
terior fibers of the temporalis muscle (T1), and two absolute numbers and relative frequencies (percent-
were applied to the skin overlying the masseter mus- ages) for categorical variables. A chi-square test with
cle, 2.5 cm anterior to the tragus and 1.5 cm inferior residual analysis was used to compare categorical
to the zygomatic arch (the point of origin of the mas- variables. Two-way repeated-measures analysis of
seter muscle [M1]) and 1 cm superior and 2 cm ante- variance (ANOVA) was used to compare continuous
rior from the mandibular angle (the point of insertion outcome variables. The factors analyzed were group
of the masseter muscle [M2]).46 The extratrigeminal (CG and COG) and time (baseline, posttreatment,

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Garrigós-Pedrón et al

Assessed for eligibility

(n = 65)

Enrollment
Excluded (n = 13)
Not meeting inclusion criteria (n = 5)
Declined to participate (n = 8)
Randomized
(n = 52)
Allocation

Cervical treatment group (n = 26) Cervical and orofacial treatment group (n = 26)
Received intervention (n = 24) Received intervention (n = 25)
Withdrawn (not compatible schedules) (n =2) Withdrawn (not compatible schedules) (n = 1)
Follow-up

Lost to follow-up (n = 2) Lost to follow-up (n = 2)

•Pregnancy (n = 1) •Death in family (n = 1)
•Surgical intervention (n = 1) •Nonadherence to treatment (n = 1)
Analysis

Analyzed (n = 22) Analyzed (n = 23)

Fig 3  Flowchart of progression of participants through the study.

and follow-ups 1 and 2). The time × group interaction, to the CG, and 26 to the COG. In the CG, two par-
which is the hypothesis of interest, was also analyzed. ticipants did not receive treatment due to incom-
Partial eta-squared (η2p) was calculated as a measure patible schedules and two participants were lost to
of effect size (strength of association) for each main follow-up due to pregnancy and surgical interven-
effect and interaction in the ANOVA: 0.01 to 0.059 tion. In the COG group, one participant did not re-
represented a small effect, 0.06 to 0.139 a medium ceive treatment due to incompatible schedules and
effect, and > 0.14 a large effect.52 Post hoc analysis two participants were lost to follow-up due to death
with Bonferroni correction was performed in cases of in the family and nonadherence to treatment. Finally,
significant ANOVA findings for multiple comparisons 45 participants (39 women and 6 men) with chron-
between variables. The post hoc analysis was per- ic migraine and TMD aged 18 to 65 years were in-
formed to analyze changes in measurement time by cluded for the final analysis. Figure 3 shows the
comparing the baseline to follow-up data (posttreat- progression of participants throughout the study. No
ment, follow-up 1, follow-up 2). Effect sizes (d) were adverse effects were reported as a result of the inter-
calculated according to Cohen’s method, in which vention. Sociodemographic data of the samples did
the magnitude of effect was classified as small (0.20 not present statistically significant differences (P >
to 0.49), medium (0.50 to 0.79), or large (≥ 0.8).53 .05) between groups for age, weight, height, duration
Cohen’s d was calculated for the results of the multiple of pain, pain intensity, educational level, and employ-
comparisons with the post hoc tests and for the com- ment status. The demographic and clinical data are
parison of the descriptive variables between groups. summarized in Table 1. The descriptive statistics for
A P value < .05 was considered to reflect statistical psychological variables, PPTs, and MMO at baseline
significance. assessment revealed no significant differences be-
tween the two groups (Table 2).

Results Primary Outcomes

CF-PDI. ANOVA revealed statistically significant dif-
A total of 52 participants were included in the study ferences for the group × time interaction (F = 3.49;
and assigned to one of two groups: 26 participants P = .027; η2p = 0.075). In the CG, post hoc analysis

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 Garrigós-Pedrón et al

Table 1  Summary of Demographic and Clinical Data

Measure CG (n = 22) COG (n = 23) P value
Age, mean (SD) (y) 48.2 (11.3) 46.0 (9.1) .47
Gender, n (%)      
 Male 3.0 (13.6) 3.0 (13) 1.00
 Female 19.0 (86.4) 20.0 (87)  
Weight, mean (SD) (kg) 66.9 (11.9) 69.8 (12.6) .43
Height, mean (SD) (cm) 164.1 (5.5) 165.7 (8.9) .45
Body Mass Index, mean (SD) (kg/m2) 24.6 (3.9) 25.4 (4.4) .56
Duration of pain, mean (SD) (y) 28.1 (12) 22.6 (12) .13
VAS, mean (SD) (mm) 69.6 (12.8) 73.5 (13) .34
Educational level, n (%)     .32
 Primary 7.0 (31.8) 3.0 (13)  
 Secondary 9.0 (40.9) 12.0 (52.2)  
 College 6.0 (27.3) 8.0 (34.8)  
Employment status, n (%)     .49
  Active worker 12.0 (54.6) 10.0 (43.5)  
 Unemployed 8.0 (36.4) 8.0 (34.8)  
  Others (sick leave, unable, retired) 2.0 (9.1) 5.0 (21.7)
CG = cervical group; COG = cervical and orofacial group; SD = standard deviation; VAS = visual analog scale.

Table 2 Descriptive Statistics for Psychological, Pain, and Disability Variables, PPTs, and Pain-free
MMO at Baseline
CG (n = 22) COG (n = 23) Mean  
Variables Mean (SD) Mean (SD) differences 95% CI Effect size (d) P value
HIT-6 66.59 (6.05) 65.52 (3.69) 1.07 (­–1.93, 4.07) 2.22 .48
TSK-11 26.09 (9.19) 25.48 (9.15) 0.61 (­–4.90, 6.13) 0.07 .82
CF-PDI 21.45 (8.37) 21.35 (11.68) 0.10 (­–6.03, 6.24) 0.01 .97
VAS (mm) 69.32 (12.75) 76.30 (11.60) –6.99 (­–14.31, 0.34) –0.57 .06
PPTs (kg/cm2)          
 T1 2.08 (0.50) 1.81 (0.45) 0.27 (­– 0.02, 0.56) 0.57 .06
 M1 1.89 (0.54) 1.78 (0.43) 0.11 (­– 0.18, 0.41) 0.23 .45
 M2 1.55 (0.36) 1.44 ( 0.31) 0.11 (­– 0.09, 0.31) 0.33 .27
 CP 3.47 (1.18) 3.16 (0.85) 0.32 (­– 0.30, 0.93) 0.30 .31
Pain-free MMO (mm) 31.41 (8.75) 32.87 (7.16) ­–1.46 (­–6.26, 3.34) –0.18 .54
CG = cervical group; COG = cervical and orofacial group; CF-PDI = Craniofacial Pain and Disability Inventory; HIT-6 = Headache Impact Test; TSK-11 =
Tampa Scale for Kinesiophobia; VAS = visual analog scale; PPT = pressure pain threshold; T1 = temporalis muscle; M1 = origin of masseter muscle;
M2 = insertion of masseter muscle; CP = control point; MMO = maximal mouth opening; CI = confidence interval; SD = standard deviation.

showed no statistically significant differences be- ferences were found between baseline, posttreat-
tween baseline and posttreatment (P > .05), whereas ment, and follow-ups 1 and 2 (P < .001). Statistically
statistically significant differences between base- significant differences were found between the
line and follow-ups 1 and 2 (P < .05) were found. groups at follow-up 2 (P = .002). Descriptive data
Additionally, in the COG, statistically significant dif- and post hoc results are shown in Table 3.
ferences were found between baseline and post-
treatment (P = .001) and between baseline and Secondary Outcomes
follow-ups 1 and 2 (P < .001). Statistically significant TSK-11. ANOVA revealed no statistically significant
differences were found between groups at follow-up differences for the group × time interaction (F = 1.01;
2 (P = .042). Descriptive data and post hoc results P = .37; η2p = 0.023). Descriptive data and post hoc
are shown in Table 3. results are shown in Table 3.
HIT-6. Statistically significant differences were Pain Intensity (VAS). ANOVA revealed statisti-
found for the group × time interaction (F = 9.83; P cally significant differences for the group × time in-
< .001; η2p = 0.19). In the CG, the post hoc anal- teraction (F = 21.41; P < .001; η2p = 0.33). In the
ysis showed statistically significant differences be- CG, the post hoc analysis showed statistically sig-
tween baseline and posttreatment (P < .001) and nificant differences between baseline, posttreatment,
between baseline and follow-ups 1 and 2 (P < .05). and follow-up 1 (P < .05), whereas no statistically
Furthermore, in the COG, statistically significant dif- significant differences were found between baseline

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Table 3 Descriptive Data and Multiple Comparisons of the Pain and Psychological Outcome
Measures at Each Measurement Point With Respect to Baseline
Baseline Posttreatment Mean difference (95% CI);
Measure/group Mean (SD) Mean (SD) Effect size (d)
CF-PDI
 CG 21.45 (8.37) 18.95 (6.77) 2.5 (–1.05 to 6.05);
d = 0.30
 COG 21.35 (11.68) 16.22 (11.20) 5.13 (1.66 to 8.6);*
d = 0.44
 Mean difference (95% CI); 0.10 (–6.03 to 6.24); 2.74 (–2.86 to 8.33);  
Effect size (d) d = 0.01 d = 0.29
HIT-6      
 CG 66.59 (6.05) 62.23 (6.23) 4.36 (1.61 to 7.12);**
d = 0.72
 COG 65.52 (3.69) 60.87 (6.68) 4.65 (1.96 to 7.35);**
d = 1.26
 Mean difference (95% CI); 1.07 (–1.93 to 4.07); 1.36 (–2.53 to 5.25);  
Effect size (d) d = 2.22 d = 0.21
TSK-11
 CG 26.09 (9.19) 25.05 (7.76) 1.04 (–2.23 to 4.33);
d = 0.11
 COG 25.48 (9.15) 23.30 (7.99) 2.18 (–1.03 to 5.38);
d = 0.24
 Mean difference (95% CI); 0.61 (–4.90 to 6.13); 1.75 (–3.00 to 6.48);  
Effect size (d) d = 0.07 d = 0.22
VAS (mm)
 CG 69.32 (12.75) 59.86 (16.21) 9.46 (2.38 to 16.54);*
d = 0.74
 COG 76.30 (11.60) 59.65 (14.26) 16.65 (9.73 to 23.58);**
d = 1.31
 Mean difference (95% CI); –6.99 (–14.31 to 0.34); 0.21 (–8.96 to 9.38);
Effect size (d) d = –0.57 d = 0.01
CG = cervical group; COG = cervical and orofacial group; CI = confidence interval; Follow-up 1 = 6 weeks posttreatment; Follow-up 2 = 12 weeks post-
treatment; CF-PDI = Craniofacial Pain and Disability Inventory; HIT-6 = Headache Impact Test; TSK-11 = Tampa Scale for Kinesiophobia; VAS = visual
analog scale; SD = standard deviation. *P < .05; **P < .001.

and follow-up 2. In the COG, statistically significant (P = .018), and baseline and follow-up 2 (P = .001)
differences were found between baseline, posttreat- were found in the COG.
ment, and follow-ups 1 and 2 (P < .001). Statistically For M2, ANOVA revealed that significant differ-
significant differences were found between groups at ences were present for the group × time interaction
follow-up 2 (P = .001). Descriptive data and post hoc (F = 10.67; P < .001; η2p = 0.20). In the CG, the
results are shown in Table 3. post hoc analysis showed no statistically significant
PPTs in the Trigeminal and Extratrigeminal differences (P > .05) over time. However, statistically
Regions. For T1, ANOVA revealed statistically sig- significant differences between baseline and post-
nificant differences for the group × time interaction treatment (P < .05) and between baseline and fol-
(F = 15.12; P < .001; η2p = 0.26). In the CG, the low-ups 1 and 2 (P < .001) were found in the COG.
post hoc analysis showed no statistically significant No statistically significant differences were found in
differences (P > .05) over time. By contrast, in the the extratrigeminal region (wrist) for the group × time
COG, statistically significant differences were found interaction (F = 2.79; P = .55; η2p = 0.061).
between baseline and posttreatment (P < .001), When analyzing the three trigeminal points, sta-
baseline and follow-up 1 (P = .002), and baseline tistically significant differences were found between
and follow-up 2 (P < .001). groups at follow-up 2 (P < .05). The descriptive data
For M1, ANOVA showed statistically signifi- and multiple comparisons are summarized in Table 4.
cant differences for the group × time interaction Pain-Free MMO. Statistically significant differ-
(F = 6.83; P = .001; η2p = 0.14). In the CG, post ences were found for the group × time interaction
hoc analysis showed no statistically significant dif- (F = 12.01; P < .001; η2p = 0.22). In the CG, the
ferences (P > .05) over time. Nevertheless, statis- post hoc analysis showed no statistically significant
tically significant differences between baseline and differences (P > .05) over time. However, in the
posttreatment (P = .001), baseline and follow-up 1 COG, statistically significant differences were found

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Follow-up 1 Mean differencs (95% CI); Follow-up 2 Mean difference (95% CI);
Mean (SD) Effect size (d) Mean (SD) Effect size (d)

16.86 (7.84) 4.6 (0.74 to 8.45);* 17.14 (8.12) 4.32 (0.43 to 8.21);*
d = 0.55 d = 0.52
13.78 (9.59) 7.57 (3.80 to 11.34);** 11.61 (9.49) 9.74 (5.94 to 13.54);**
d = 0.65 d = 0.83
3.08 (–2.20 to 8.36);   5.53 (0.21 to 10.85);*  
d = 0.35 d = 0.63
       
61.59 (8.12) 5.0 (1.24 to 8.76);* 61.50 (8.92) 5.09 (0.36 to 9.82);*
d = 0.83 d = 0.84
56.96 (8.73) 8.57 (4.9 to 12.24);** 51.83 (10.87) 13.70 (9.1 to 18.32);**
d = 2.32 d = 3.71
4.63 (–0.44 to 9.71);   9.67 (3.68 to 15.67);*  
d = 0.55 d = 0.97
 
23.95 (7.02) 2.14 (–1.92 to 6.19); 23.73 (6.23) 2.36 (–1.79 to 6.52);
d = 0.23 d = 0.26
22.30 (8.25) 3.18 (–0.79 to 7.14); 20.22 (9.01) 5.26 (1.20 to 9.33);
d = 0.35 d = 0.58
1.65 (–2.97 to 6.27);   3.51 (–1.17 to 8.19);  
d = 0.22 d = 0.45
 
59.55 (18.60) 9.77 (1.61 to 17.93);* 64.05 (19.82) 5.27 (–4.49 to 15.04);
d = 0.77 d = 0.41
53.83 (17.35) 22.48 (14.50 to 30.46);** 41.26 (21.50) 35.04 (25.50 to 44.59);**
d = 1.76 d = 2.75
5.72 (–5.09 to 16.53); 22.79 (10.34 to 35.23);**  
d = 0.32 d = 1.10

between baseline, posttreatment, and follow-ups 1 cervicogenic headache and TMD increases pain-free
and 2 (P < .001). Statistically significant differenc- MMO.27 A similar finding was shown when education-
es were observed between groups in posttreatment al treatment, manual therapy, and therapeutic exercis-
(P = .014) and follow-ups 1 and 2 (P = .003 and es in the cervical and orofacial regions were applied
P = .01, respectively). Descriptive data and post hoc to patients with bilateral disc displacement without
results are shown in Table 4. reduction of the TMJ.50 Furthermore, a previous study
demonstrated that only the application of manual
therapy and exercises at the cervical spine increased
Discussion MMO in patients with myofascial TMD.26 A possible
explanation for the different results could be differenc-
This study was designed to investigate the effects of es in the type of patient.
adding orofacial treatment to cervical physical therapy in In terms of trigeminal PPTs, statistically significant
patients with chronic migraine and TMD, as well as to pro- differences were found only in the COG. In addition,
vide new evidence on the effects of manual therapy and statistically significant differences were revealed be-
therapeutic exercises in patients with this comorbidity. tween the CG and COG at the last follow-up peri-
In the case of pain-free MMO, the study revealed od. This result is in agreement with a previous study
statistically significant differences only in the COG at showing increased PPTs in this region after cervi-
each time point the measurements were carried out cofacial physical therapy in patients with headache
with respect to baseline, and statistically significant and TMD.27 This result was also in agreement with
differences were also observed between the CG findings in patients with migraine and cervical pain
and COG at posttreatment and follow-ups 1 and 2. and also in patients with myofascial TMD after appli-
Previous evidence has shown that the application of cation of manual therapy and exercises at the cervical
orofacial and cervical physical therapy in patients with spine.26,54

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Table 4 Descriptive Data and Multiple Comparisons of the Physical Outcome Measures at
Each Measurement Time Point With Respect to Baseline
Baseline Posttreatment Mean difference (95% CI);
Measure/group Mean (SD) Mean (SD) Effect size (d)
PPT T1
 CG 2.08 (0.50) 2.03 (0.50) 0.06 (–0.12 to 0.23);
d = 0.10
 COG 1.81 (0.45) 2.18 (0.58) –0.37 (–0.54 to –0.20);**
d = –0.82
 Mean difference (95% CI); 0.27 (–0.02 to 0.56);  –0.15 (–0.48 to 0.17);
Effect size (d) d = 0.57 d = –0.28
PPT M1
 CG 1.89 (0.54) 1.96 (0.54) –0.08 (–0.28 to 0.13);
d = –0.13
 COG 1.78 (0.43) 2.09 (0.63) –0.31 (–0.51 to –0.11);*
d = –0.72
 Mean difference (95% CI); 0.11 (­– 0.18 to 0.41); –0.12 (–0.49 to 0.23);  
Effect size (d) d = 0.23 d = –0.22
PPT M2
 CG 1.55 (0.36) 1.57 (0.44) –0.02 (–0.19 to 0.15);
d = –0.06
 COG 1.44 (0.31) 1.69 (0.48) –0.25 (–0.42 to –0.09);*
d = –0.81
 Mean difference (95% CI); 0.11 (–0.09 to 0.31); –0.12 (–0.40 to 0.16);  
Effect size (d) d = 0.33 d = –0.26
PPT CP
 CG 3.47 (1.18) 3.44 (1.06) 0.04 (–0.29 to 0.36);
d = 0.03
 COG 3.16 (0.85) 3.47 (0.91) –0.32 (–0.63 to –0.001);
d = –0.37
 Mean difference (95% CI); 0.32 (–0.30 to 0.93); –0.04 (–0.63 to 0.56);  
Effect size (d) d = 0.30 d = –0.03
Pain-free MMO
 CG 31.41 (8.75) 31.64 (8.48) –0.23 (–2.28 to 1.82);
d = –0.03
 COG 32.87 (7.16) 37.22 (5.98) –4.35 (–6.35 to –2.34);**
d = –0.61
 Mean difference (95% CI); –1.46 (–6.26 to 3.34); –5.58 (–9.98 to –1.19);*  
Effect size (d) d = –0.18 d = –0.76
CG = cervical group; COG = cervical and orofacial group; Follow-up 1 = 6 weeks posttreatment; Follow-up 2 = 12 weeks posttreatment;
CI = confidence interval; PPT = pressure pain threshold; T1 = temporalis muscle; M1 = origin of masseter muscle; M2 = insertion of
masseter muscle; CP = control point (wrist); MMO = maximal mouth opening; SD = standard deviation. *P < .05; **P < .001.

In relation to the PPTs in the extratrigeminal re- These results have shown overall positive outcomes
gion (wrist), studies have shown a general hyper- for muscle pain, given an increase in PPTs at the an-
sensitivity in patients with concomitant migraine and terior temporalis (area of migraine pain) and at the
TMD compared to patients having only migraine or masseter muscle (area of TMD pain).
TMD. This finding could be related to central modifi- Regarding pain intensity, HIT-6, and CF-PDI
cations in pain pathways.55 The present PPT findings variables, the present study revealed statistically
indicated that physical therapy at either the cervical significant differences in both groups, although the
or in both the cervical and orofacial regions produced improvement in these variables was higher in the
a localized hypoalgesic effect in the trigeminal region, COG. A statistically significant difference between
but not in the extratrigeminal region. groups was found at the last follow-up period. These
In agreement with these results, previous studies results suggest that both treatments were effective
obtained hypoalgesia only in the area where treat- for reducing pain, craniofacial disabilities, and the im-
ment was applied, and in these studies, the partici- pact of headache on daily life in patients with chronic
pants also presented with more than one disorder.56,57 migraine and TMD.
However, other studies in which the sample consist- In the case of pain intensity, these results are in
ed of patients without comorbidities have shown that agreement with other studies that demonstrated a
the application of manual therapy and therapeutic reduction in pain after applying multimodal physio-
exercises produced generalized hypoalgesia.58–61 therapy treatment in chronic tension-type headache,

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Follow-up 1 Mean differencs (95% CI); Follow-up 2 Mean difference (95% CI);
Mean (SD) Effect size (d) Mean (SD) Effect size (d)

1.91 (0.46) 0.18 (–0.08 to 0.43); 1.85 (0.48) 0.24 (–0.03 to 0.50);
d = 0.34 d = 0.46
2.15 (0.59) –0.34 (–0.59 to –0.10);* 2.32 (0.61) –0.50 (–0.76 to –0.24);**
d = –0.76 d = –1.13 
–0.25 (–0.56 to 0.07); –0.47 (–0.80 to –0.14);*  
d = –0.45 d = –0.85

1.90 (0.59) –0.01 (–0.28 to 0.26); 1.75 (0.57) 0.13 (–0.16 to 0.42);
d = –0.02 d = 0.26
2.08 (0.54) –0.30 (–0.57 to –0.03);* 2.19 (0.63) –0.42 (–0.70 to –0.13);*
d = –0.70 d = –0.95
–0.18 (–0.52 to 0.16); –0.44 (–0.80 to –0.08);*
d = –0.32 d = –0.73

1.53 (0.43) 0.02 (–0.17 to 0.21); 1.47 (0.39) 0.08 (­– 0.16 to 0.31);
d = 0.06 d = 0.22
1.74 (0.45) –0.30 (–0.50 to –0.12);** 1.87 (0.48) –0.43 (–0.66 to –0.20);**
d = –0.97 d = –1.39
–0.21 (–0.48 to 0.05);    –0.40 (–0.66 to –0.14);*
d = –0.48 d = ­– 0.91

3.34 (1.06) 0.13 (–0.31 to 0.58); 3.18 (1.01) 0.29 (–0.17 to 0.74);
d = 0.11 d = 0.25
3.35 (0.85) –0.19 (–0.62 to 0.24); 3.42 (0.91) –0.27 (–0.71 to 0.18);
d = –0.22 d = –0.31
–0.01 (–0.58 to 0.57);   –0.24 (–0.82 to 0.34);
d = –0.01 d = –0.25

32.32 (8.76) –0.91 (–3.32 to 1.50); 32.36 (9.58) –0.96 (–4.33 to 2.42);
d = –0.10 d = –0.11
39.13 (5.67) –6.26 (–8.62 to –3.90);** 41.13 (6.49) –8.26 (–11.56 to –4.96);**
d = –0.87 d = –1.15
–6.81 (–11.23 to –2.40);*   –8.77 (–13.67 to –3.87);*
d = –0.93 d = –1.08

cervical manual therapy in chronic neck pain, and Finally, the present study found that the physio-
cervical and orofacial treatment in TMD.50,62,63 therapy treatment used, which was based on manual
Nevertheless, the present results do not agree with therapy, was not effective in reducing fear of move-
those obtained by von Piekartz and Lüdtke, who ment. A previous study applying manual therapy in
compared cervical treatment to cervical and orofa- the cervical region in patients with neck pain have
cial treatment in patients with cervicogenic head- found similar results.65 The authors of the present
ache and TMD.27 They found that only the cervical study believe that other physiotherapy treatments
and orofacial treatment significantly decreased pain that focus on a biobehavioral perspective could be
as measured through a colored analog scale, which effective in decreasing kinesiophobia in patients with
is a pain intensity scale similar to the VAS that was migraine and TMD. Previous scientific studies have
designed especially for patients with headache of indicated that treatments such as therapeutic educa-
various age categories.27,64 tion,66–68 graduated exposure,68,69 and graded activi-
In relation to the HIT-6, the present findings are in ty70–72 are effective in decreasing fear of movement in
agreement with previous studies. Multimodal physio- other chronic musculoskeletal disorders.
therapy in the cervical region in chronic tension-type In terms of pharmacologic treatment, both groups
headache and cervical and orofacial physical therapy continued their medication regimens during the study
in migraine and chronic neck pain decreased the im- period in accordance with a previous study.20 For
pact of headache on patients’ daily lives.54,62 ethical reasons, participants could not be withdrawn

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from pharmacologic treatment during the study. All pain. However, the physical therapy treatment alone
had a similar intake of routine preventive and abor- was not effective for increasing the PPT in the ex-
tive treatment at the onset of migraine attacks. The tratrigeminal region (wrist) or decreasing the level of
medication was prescribed by a headache specialist kinesiophobia.
neurologist. These participants had been taking med-
ication for many years without significant improve-
ments, and so it is unlikely that the improvements Acknowledgments
found in this study would have been specifically due
to the medication. Clinical Trials Register: NCT02627014. The authors report no
conflicts of interest.
Practical and Scientific Implications
To the best of the authors’ knowledge, this study is
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