Eur J Phys Rehabil Med. 2016 (Aug); 52 (4): 447—456 ~ FULL TEXT
Gemma V. Espí-López , Cleofas Rodríguez-Blanco, Angel Oliva-Pascual-Vaca,
Francisco J. Molina-Martínez, Deborah Falla
Department of Physiotherapy,
University of Valencia,
BACKGROUND: Controversy exists regarding the effectiveness of manual therapy for the relief of tension-type headache (TTH). However most studies have addressed the impact of therapy on the frequency and intensity of pain. No studies have evaluated the potentially significant effect on the patient's quality of life.
AIM: To assess the quality of life of patients suffering from TTH treated for 4 weeks with different manual therapy techniques.
DESIGN: Factorial, randomized, single-blinded, controlled clinical trial.
SETTING: Specialized center for the treatment of headache.
POPULATION: Seventy-six (62 women) patients aged between 18 and 65 years (age: 39.9 ± 10.9) with either episodic or chronic TTH.
METHODS: Patients were divided into four groups: suboccipital inhibitory pressure; suboccipital spinal manipulation; a combination of the two treatments; control. Quality of life was assessed using the SF-12 questionnaire (considering both the overall score and the different dimensions) at the beginning and end of treatment, and after a one month follow-up.
RESULTS: Compared to baseline, the suboccipital inhibition treatment group showed a significant improvement in their overall quality of life at the one month follow-up and also showed specific improvement in the dimensions related to moderate physical activities, and in their emotional role. All the treatment groups, but not the control group, showed improvements in their physical role, bodily pain, and social functioning at the one month follow-up. Post treatment and at the one month follow-up, the combined treatment group (suboccipital inhibitory pressure and suboccipital spinal manipulation) showed improved vitality and the two treatment groups that involved manipulation showed improved mental health.
CONCLUSIONS: All three treatments were effective at changing different dimensions of quality of life, but the combined treatment showed the most change. The results support the effectiveness of treatments applied to the suboccipital region for patients with TTH.
CLINICAL REHABILITATION IMPACT: Manual therapy techniques applied to the suboccipital region, for as little as four weeks, offered a positive improvement in some aspects of quality of life of patient's suffering with TTH.
Key words: Treatment outcome - Tension-type headache - Musculoskeletal manipulations - Quality of life.
From the FULL TEXT Article:
Tension-type headache (TTH) is the most common
primary headache. The high prevalence of TTH is
associated with significant social and economic impact,
and is responsible for a high percentage of visits to different
health professionals. [1, 2] Understandably, TTH
also affects quality of life, including performance of
work and everyday household activities, social life, and
leisure activities. 
Stress and pericranial muscle spasms might play an
important role in the pathophysiology of this disorder. 
These factors, as well as mechanisms involving central
and peripheral sensitization, explain the presence
of painful pericranial tenderness and the lower pain
threshold observed in this region in patients with TTH.
Tender points on the neck and head also become more
Controversy exists regarding the effectiveness of
physical therapy for the relief of TTH.  The evidence
that spinal manipulation alleviates TTH is encouraging,
but not always conclusive due to the low quality of
the studies.  There is the need for further randomized
controlled trials of high quality to specifically evaluate
the effectiveness of these interventions in patients with
TTH.  Moreover, most studies have addressed the impact
of therapy on the frequency and intensity of headache,
and occasionally the impact of such pain or its
duration, but no studies have evaluated the potentially
significant effect on the patient’s quality of life. In this
study we hypothesized that manual therapy techniques
applied to the suboccipital region with the aim of reducing
soft tissue tension, both separately and in combination,
would improve aspects of quality of life of patients
suffering with TTH. Thus, this study assessed the effectiveness
of manual therapy on the overall quality of life
and different dimensions of quality of life in patients
with episodic (ETTH) or chronic (CTTH) TTH. Specifically,
we evaluated the effect of suboccipital inhibitory
pressure (SI) and suboccipital manipulation (SM) and
the combination of both. Changes in quality of life were
noted immediately after four weeks of intervention and
at a one-month follow-up
Materials and methods
Patients were considered for the study if they were
clinically stable and without any other concomitant disease.
Subjects were enrolled for the study if they were
aged between 18 and 65 years, had been diagnosed with
TTH for more than three months, had episodes of headache
lasting from 30 minutes to 7 days, and fulfilled two
or more of the following characteristics: bilateral location
of pain, non-pulsatile pressure pain, mild to moderate
pain, a headache that does not worsen with physical activity.
In addition, the headache could be associated with
pericranial tenderness and should be controlled pharmacologically
but the medication could not be altered during
the course of the study. Detailed inclusion and exclusion
criteria are presented in Table I. During the three
month period prior to starting the study, an experienced
neurologist was responsible for identifying patients and
confirming the diagnosis of TTH. A radiological examination
was performed on all participants (as part of the
routine evaluation in this setting) to rule out major structural
abnormalities in this regard and pathological rigidity.
Eighty-seven subjects were initially selected for the
study and 76 were included due to the exclusion of 11
subjects (Figure 1). Of those included, 62 were women
(81.6%) and 14 were men (18.4%). The mean age was
39.9 years (SD 10.9), ranging from 18 to 65 years.
The study was conducted from March to December,
2013 at the University of Valencia (Spain) and treatment
was carried out in a specialized center for the treatment
of headache. The sample consisted of patients with TTH
diagnosed by an experienced neurologist considering
headache characteristics established by the International
Headache Society (IHS). [9, 10]
Inclusion and exclusion criteria.
Participant flowchart according to
the CONSORT Statement for the report
of randomized trials.
The study was a factorial, randomized, single-blinded,
controlled clinical trial. After the initial clinical
interview conducted by a specialist manual therapist,
patients were randomly assigned to four groups:
1) SI treatment;
2) SM treatment;
3) combination of SI and SM; and
4) control group using a computer-generated
random sequence (randomized.com); which was carried
out by an assistant who was unaware of the treatments
administered to each group or the study objectives.
sampling processes were performed according to nonprobabilistic
convenience sampling techniques. Patients
and the examiner were unaware of critical study factors.
The therapists were not informed of the type of study
being conducted or the aim of the study, and statistical
analyses were conducted by an external specialist.
The number of subjects required in each group was
estimated with the nQuery Advisor software program.
For an ANOVA with one inter-subject factor, with four
groups, and assuming a 5% significance level for a large
effect, the required number was 19 subjects per group.
All patients were assessed under the same conditions
prior to treatment, after treatment (at 4 weeks), and at a
follow-up (one month after completion of treatment).
The study was approved by the Ethics Committee of
the University of Valencia (Spain) with the number
H1380701837435 and prior to their assignment to a
group, the subjects gave written informed consent. The
trial was registered at Trial.gov with register number
Each subject received four treatment sessions, each
lasting approximately 20 minutes, with 7-day intervals.
Treatments were performed at a specialized center for
the treatment of headache. Prior to the intervention and
with the patient in a supine position, a test for a possibly
compromised vertebral artery was performed bilaterally
to determine the advisability of treatment. This test was
applied to all subjects, including the control subjects.
The specific etiology of signs and symptoms caused by
the test as well as its effectiveness for ensuring the absence
of vascular injury remain unclear. [11, 12] However,
before enrolment in the study, patients with symptoms
suggestive of possible vertebrobasilar insufficiency were
excluded. Subsequently, with the subject in the same position
on a treatment bed, the treatment technique was
applied according to the group allocation. The therapists
had more than 10 years’ experience each in the application
of manual therapy for patients with primary headaches.
Techniques were always applied cautiously by
the experienced specialists in manual therapy to avoid
any potential adverse events. Adverse events were monitored
by the therapists throughout the treatment sessions
and patients were specifically asked at the beginning of
subsequent treatment sessions about the occurrence of
any adverse events since the last treatment session.
The suboccipital musculature was palpated until
contact was made with the posterior arch of the atlas,
and progressive and deep gliding pressure was applied,
pushing the atlas anteriorly. The occiput rested on the
hands of the therapist while the atlas was supported by
the fingertips. Finger pressure was maintained for 10
minutes to produce the proposed therapeutic effect of
inhibiting the suboccipital soft tissues. The aim of the
technique is to suppress spasm of the muscles and in
general of the suboccipital soft tissues which may be
contributing to dysfunctional mobility of the occiput,
atlas, or even the axis. 
This technique was performed along an imaginary
vertical line passing through the odontoid process
of the axis. No flexion or extension and very little lateral
flexion were used. Application was bilateral. First, cephalic
decompression was performed lightly, followed
by small circumductions. Selective tension was applied
to take up tissue slack and create a firm joint barrier.
Manipulation was then performed with rotation towards
the manipulated side in a helicoidal cranial movement.
This technique was applied with the aim of increasing
occiput, atlas, and axis joint mobility. [14-16]
Combined treatment. —
This group received the above
two techniques always in the same sequence: first the SI
technique followed by the SM.
Control group. —
The subjects received no treatment,
but attended the same number of sessions, maintaining
the resting position for longer than the treatment
groups, and underwent the same evaluations (test for
arterial compromise, and the three assessments).
Resting position. —
The subjects remained in a resting
position in supine with a neutral position of their head
and neck for 5 minutes after treatment in the treatment
groups, and for 10 minutes in the control group.
A clinical interview was conducted by a specialist
Manual Therapist in the month preceding the study to
gather headache-related data from the subjects. These
included major aspects for TTH verification, including
frequency of noted pain (less than 15 days monthly =
ETTH; more than 15 days monthly = CTTH), location
and laterality of pain, type of pressure and intensity response
to the classification of the IHS, [9, 10] and severity
The SF-12v2 (Short Form 12 Health Survey) health
status questionnaire was used to assess the subject’s
quality of life and the questionnaire has established reliability. [17, 18] The Spanish version presented by Alonso
et al.  and Monteagudo et al.  was adopted. The SF-
12v2 is a reduced version of SF-36  and is designed
to reduce the length of the questionnaire by including
fewer questions. The initial version of the questionnaire
was developed in the USA in 1994,  and the version
used in the present study is from 2002.  The survey
provides a health status profile consisting of 12 questions
taken from the 8 dimensions of SF-36:  Moderate
activities (Physical Functioning), Climb several flights
of stairs (Physical functioning), Accomplished less than
you would like (Physical Role), Limited in kind of work
(Physical Role), Extent Pain interfered (Bodily Pain),
Health in general (General Health), Energy (Vitality),
Social time (Social Functioning), Accomplished less
than you would like (Emotional Role), Didn’t do work
as carefully as usual (Emotional Role), Calm and Peaceful
(Mental Health), Downhearted and depressed (Mental
Health). Higher scores indicate better health, up to a
maximum of 100 points. This is a registered instrument
and its use was authorized for the present study.
The quality of life was assessed using this instrument
at three stages of the study: before treatment, after treatment
(at 4 weeks), and at follow-up (one month after
completion of treatment). All subjects were evaluated
under the same conditions for the three study phases.
Statistical analyses were performed by an independent
external statistician blinded to group allocation.
Descriptive statistical analyses were made for the overall
sample, and then for the groups separately, considering
the absolute and relative frequencies, correlations
between the study variables, and the mean scores with
their standard deviations and confidence intervals.
For the pre-test, an ANOVA was used which confirmed
the homogeneity of the groups before starting
treatment, including the calculation and interpretation
of the effect size (0.2 was regarded as small, 0.5
as medium and 0.8 as large) and the Levene statistic to
verify the assumption of homoscedasticity. In cases of
statistical significance, the Welch and the Brown-Forsythe
robust F-tests were applied. The t-test for related
samples was used to compare the pre-test, post-test, and
follow-up means (for each group separately), followed
by the calculation and interpretation of the effect size.
The Kolmogorov-Smirnov Test was applied separately
for each group and for each measure to verify compliance
with normality. When the data were not normally
distributed, differences were evaluated by the non-parametric Wilcoxon Test. The level of significance set for
all analyses was 5%.
Demographic analysis and headache characteristics
Of the sample, 40.8% of the subjects suffered from
CTTH, and 59.2% from ETTH. Table II presents the
headache characteristics of the study sample. The mean
value of pain intensity as evaluated by the Visual Analogue
Scale (VAS) was 6.5 (SD 1.7).
In 51.3% of the patients, pain was triggered by physical
or mental tiredness. Stress was considered to be the
most conditioning factor for 69.7% of the patients. On
the other hand, among stress factors, work-related factors
affected 52.6% of the sample, while emotional,
family and studying-related factors affected 19.7%,
19% and 7.9% respectively of the entire sample.
Analysis of quality of life
At the start of treatment, the subjects presented lower
than normative values for their quality of life (mean
39.2, SD 3.9). The overall quality of life remained
unchanged in all groups, except in the SI group at the
follow-up with a medium effect size (Table III). The
individual analyses by dimension revealed that “Moderate
activities” in the Physical Functioning dimension
represented no major change in the SI group. Regarding
the Physical Role, the dimension “Accomplished less
than you would like” showed a statistically significant
change in all groups, while “Limited in kind of work”
only improved in the three treatment groups but not the
For Bodily Pain and Social Functioning, improvements
were noted in all treatment groups but not the
control group. With regard to Vitality, both of the comparative
evaluations in the combined treatment group
showed significant improvements with the effect size
being medium-to-high. For the Emotional Role, “Accomplished
less than you would like”, a significant
change was observed for the SI group and the combined
treatment group, and “Didn’t do work as carefully as
usual” improved in the SM and combined treatment
group. Finally, for Mental Health, “Calm and Peaceful”
showed significant improvement after treatment in the
SM group, and at the one month follow-up in the SM
and combined treatment group, while “Downhearted
and depressed “ improved in the combined treatment
group at both evaluations (Table IV).
No adverse events were reported.
Demographics and headache
characteristics. Mean (SD)
Overall results of the SF-12
health questionnaire. Mean (SD)
Results for the different dimensions of the
SF-12 health questionnaire. Mean (SD)
As expected, the results confirm that TTH has specific
noted pain characteristics, [10, 11] and that TTH significantly
reduces quality of life. [1, 24] Considering their overall general
health, the patients presented with relatively poor
health before treatment, and all groups improved slightly
after treatment, but without major changes. In view of
these results we evaluated different variables of the general
health questionnaire separately to specifically understand
the areas in which the treatment was effective.
Regarding Physical Functioning, the limitations for
“Moderate activities” showed positive improvement
in the SI treatment group at the one month follow-up.
Since physical effort is one of the most important triggers
of TTH, this finding suggests that SI was the most
effective treatment for improving this aspect of quality
of life. Nevertheless, it had no effect on “Climb several
flights of stairs”; thus no treatment appears to be beneficial
for this aspect of physical function. Reduced work
productivity (“Accomplished less than you would like”)
due to emotional problems in the Emotional Role dimension
showed positive changes in the two treatment
groups that included SI treatment. In contrast, the reduced
level of care or attention paid to everyday activities
because of emotional problems (“Didn’t do work
as carefully as usual”) improved in the two groups that
received SM. The combined treatment also had a significant
effect on the vitality dimension (“Energy”, or
the frequency of feeling full of energy). With regard to
Mental Health, the frequency of feeling calm and quiet
(“Peaceful”) also showed positive changes for the two
treatments groups which including the manipulation,
and the frequency of feelings of discouragement and
depression (“Downhearted and depressed”) improved
significantly for the group that received the combined
In the Physical Role, the reduced ability to perform
everyday activities (“Accomplished less than you
would like”) improved in all groups, including the control
group (although for the latter the effect size was
smaller). However, the limitation in the kind of work
that could be undertaken (“Limited in kind of work”), as
well as the Bodily Pain and Social Functioning dimensions,
improved in all of the treatment groups, but not in
the control group, suggesting that the three treatments
applied to the suboccipital soft tissues were effective in
these aspects related to the quality of life.
The importance of the present study in understanding
and treating TTH is that, to the best of the authors’
knowledge, it is the first to evaluate the separate dimensions
of quality of life in people with TTH. Other studies
have applied exercise programs combined with manual
therapy showing a significant reduction in the frequency,
intensity, and duration of pain, and in the subject’s
overall mental health. For instance, Van Ettekoven and
Lucas  evaluated the effect of a six week program of
craniocervical exercises combined with massage and
mobilization in people with TTH and demonstrated significant
effects on headache frequency, intensity, duration
of pain, and quality of life with clinically relevant
effect sizes. Moreover, a number of studies have shown
that treatment with cervical manipulation is effective in
reducing the frequency of pain, and the duration and intensity
of headaches. [26, 27] Moreover, the combination of
different techniques together with manual therapy can
significantly reduce levels of pain intensity. [28, 29] However,
since the various techniques were applied in combination,
it is not possible to distinguish which was the
One of the techniques applied in the present study
was the inhibition of suboccipital tissue, selected with
the aim of reducing tension in the suboccipital musculature,
which is often responsible for initiating a headache.
Only one previous study has evaluated the efficacy
of the suboccipital inhibition technique,  but it was
applied in combination with muscle-energy techniques
to the suboccipital muscles, and it did not assess the patients’
quality of life. [30, 31] Castien et al. in 2011  showed
the effectiveness of a combined treatment of mobilization
of the cervical and thoracic spine and postural correction
exercises, but again, quality of life was not assessed
and the application of individual techniques was
not evaluated. The specific treatments applied in the
current study have recently been evaluated in combination
and individually, [15, 16, 33] however such studies did
not analyze the quality of life in its various dimensions.
Overall, the present results indicate that the application
of the three different treatments were effective at improving
various aspects of quality of life in people with
TTH, with differences noted between the treatments approaches.
However, a longer follow-up period would be
required to determine how long the effects last, as well
as to assess other headache related features.  Moreover,
we applied a relatively short intervention even though
current guidelines suggest longer interventions for
TTH. However, even though the treatment volume was
low (4 treatments every 7 days), the interventions had
significant effects. Other studies evaluating the effects
of vertebral mobilization, spinal manipulation or suboccipital
inhibition treatment have also reported positive
effects after interventions with a similar number
of sessions [13, 15, 16] or even less.  We assume that the
participants remained blinded to their group allocation
throughout the entire trial but we did confirm this e.g.
using a de-blinding questionnaire after each treatment
session. However, other work has demonstrated that it
is possible to conduct a single-blinded manual therapy
RCT with placebo and to maintain the blinding throughout
multiple treatment sessions over several months. 
It should be noted that the treatment techniques were
performed by qualified therapists with extensive experience.
Moreover, the study adhered to the guidelines
presented by Rushton et al.  for examination of the cervical
region for potential cervical arterial dysfunction
prior to orthopaedic manual therapy interventions. This
included a detailed patient history and physical examination.
Thus it must be emphasized that the application
of spinal manipulative techniques requires specialized
training. Moreover, it cannot be excluded that mobilization,
rather than manipulation, could have achieved the
same results. Finally, other approaches may also be effective
for increasing quality of life in people with TTH.
For example, significant effects were seen for bodily
pain, vitality, and mental health in people with TTH following
one month of adjuvant guided imagery. 
Manual therapy techniques have some influence on
different aspects of quality of life in people with TTH.
Considering the overall quality of life, the suboccipital inhibitory treatment was the most effective. When
considering individual dimensions of quality of life, the
combined treatment showed the greatest change. Separately,
the application of the suboccipital inhibitory and
manipulative treatment provided similar results.
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