Pain 112 (2004) 381–388

www.elsevier.com/locate/pain

The effectiveness of physiotherapy and manipulation in patients

with tension-type headache: a systematic review
Marie-Louise B. Lenssincka, Léonie Damena,*, Arianne P. Verhagena,
Marjolein Y. Bergera, Jan Passchierb, Bart W. Koesa
a
Department of General Practice, Erasmus MC, University Medical Centre Rotterdam, P.O. Box 1738, 3000 DR Rotterdam, The Netherlands
b
Department of Medical Psychology and Psychotherapy, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands
Received 31 March 2004; received in revised form 29 July 2004; accepted 17 September 2004

Abstract
The study design is a systematic review of randomised clinical trials (RCTs). The objectives of the present study are to assess the
effectiveness of physiotherapy and (spinal) manipulation in patients with tension-type headache (TTH). No systematic review exists
concerning the effectiveness of physiotherapy and (spinal) manipulation primarily focussing on TTH. Literature was searched using a
computerised search of MEDLINE, EMBASE and the Cochrane library. Only RCTs including physiotherapy and/or (spinal) manipulation
used in the treatment of TTH in adults were selected. Two reviewers independently assessed the methodological quality of the RCTs using
the Delphi-list. A study was considered of high quality if it satisfied at least six points on the methodological quality list. Twelve publications
met the inclusion criteria, including three dual or overlapping publications resulting in eight studies included. These studies showed a large
variety of interventions, such as chiropractic spinal manipulation, connective tissue manipulation or physiotherapy. Only two studies were
considered to be of high quality, but showed inconsistent results. Because of clinical heterogeneity and poor methodological quality in many
studies, it appeared to be not possible to draw valid conclusions. Therefore, we conclude that there is insufficient evidence to either support or
refute the effectiveness of physiotherapy and (spinal) manipulation in patients with TTH.
q 2004 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Keywords: Physiotherapy; (Spinal) Manipulation; Effectiveness; Tension-type headache; Randomised clinical trail; Systematic review

1. Introduction The diagnosis TTH is a clinical diagnosis based on the

Tension-type headache (TTH) is the most common
primary headache (Rasmussen et al., 1991; Schwartz et al.,
1998). There is no apparent underlying organic disease
process (Schwartz et al., 1998). TTH can last from 30 min to
several days (IHS, 1988). The pain is pressing/tightening in
quality, mild or moderate intense, bilateral in location and
does not worsen with routine physical activity. Since 1988,
a classification scheme of the International Headache
Society (IHS) with classification and diagnostic criteria
for headache disorders is widely used (IHS, 1988).
* Corresponding author. Tel.: C31 10 463 2135; fax: C31 10 463 2127.
E-mail address: leoniedamen@hotmail.com (L. Damen).
0304-3959/$20.00 q 2004 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
doi:10.1016/j.pain.2004.09.026
results of history taking alone. TTH is subdivided into
episodic-TTH and chronic-TTH. Episodic-TTH is charac-
terised by recurrent episodes of headache lasting minutes to
days. When headache is presented for at least 15 days a
month during at least 6 months it is labelled as Chronic-
TTH (IHS, 1988).
A lifetime prevalence of TTH in the general population is
reported in 69% of men and 88% of women (Rasmussen
et al., 1991). Although TTH is normally a benign disorder,
the human and the socio-economic impact are considerable
due to lost workdays or days with reduced work efficiency
(Schwartz et al., 1998). Twelve percent of the people with
TTH reported missing work in the previous year because of
headache (Millea and Brodie, 2002). TTH has a great
382 M.-L.B. Lenssinck et al. / Pain 112 (2004) 381–388
impact on quality of life and affects different aspects of daily
life. In a Canadian population survey, TTH patients
indicated that relationships with family, friends, and
colleagues were impaired. Regular activities were limited
in 38% of the TTH patients. TTH often resulted in
the cancellation of family and social activities (Edmeads
et al., 1993).
TTH is treated symptomatically, with the goal being
symptom relief and preventing recurrence (Millea and
Brodie, 2002). The most commonly used treatment for
TTH is medication, but a large number of headache
patients also receive various forms of physical or
psychological treatment for their headache (D’Amico
et al., 1998; Rasmussen et al., 1992). Such physical
treatments include physiotherapy, behavioural approaches,
(spinal) manipulation, exercise therapy, etc. These treat-
ments are often used when the aim is to avoid the side
effects of pharmacological treatment (D’Amico et al.,
1998; Rasmussen et al., 1992) Of most treatment options,
the effectiveness is still unclear.
Four systematic reviews have been performed on various
primary headaches including (spinal) manipulation and
physiotherapy (Astin and Ernst, 2002; Bronfort et al.,
2001; Hurwitz et al., 1996; Vernon et al., 1999). Two of
them have been performed on spinal manipulation for
various primary headaches (Astin and Ernst, 2002; Bronfort
et al., 2001). One review also included case series and case
reports for patients with primary headache and neck pain
(Hurwitz et al., 1996), while another evaluated complemen-
tary medicine therapies in the treatment of all kinds of non-
migrainous headache (Vernon et al., 1999). Therefore, we
state that there are no (high quality) systematic review
concerning the effectiveness of physiotherapy and (spinal)
manipulation primary focussing on TTH alone, which makes
it difficult for health care providers to make evidence-based
decisions regarding which physiotherapy treatment to use.
The aim of this review is to assess the evidence from RCTs
concerning the clinical effectiveness of physiotherapy and
(spinal) manipulation in patients with TTH.
2. Methods
2.1. Literature search
Studies were identified by a comprehensive compu-
terised search for an overall review on the treatment of TTH.
MEDLINE and EMBASE were searched from inception till
January 2003 using the following keywords to identify the
study population: ‘tension-type headache’, ‘tension head-
ache’, ‘stress headache’, and ‘muscle contraction head-
ache’, together with the broad search strategy described
by Robinson and Dickersin (2002) for identifying RCTs.
The Cochrane Controlled Trials Register, Cochrane Library,
issue 1 2003 was searched using the terms: ‘tension
headache’ or ‘tension-type headache’ or ‘muscle
contraction headache’. Additional strategies for identifying
trials included searching the reference lists of review
articles and studies related to headache.
Two reviewers (LD, AV) independently screened titles
and abstracts of identified published articles for eligibility.
All potentially relevant studies were retrieved as complete
manuscripts.
2.2. Study selection
Studies were considered relevant if the following criteria
were met.
2.2.1. Design
Only RCTs were included; quasi-randomised studies and
Controlled Clinical Trials (CCTs) were excluded.
2.2.2. Study population
A study was included if the study population included
adults (18 years or older) with TTH. Studies including
patients with TTH and migraine were included if the results
were stratified by headache diagnosis, but the results for
migraine were not analysed in this systematic review.
Studies, which did not adhere to one of the classification
systems (Ad Hoc Committee on Classification of the NIH,
1962; IHS, 1988) were included, but TTH diagnosis had
to be based on at least some of the distinctive features
of TTH, e.g. bilateral in location, no nausea or vomiting,
mild or moderate intensity, or no exacerbation by exercise.
2.2.3. Intervention
All studies were required to assess at least the effect of
physiotherapy or (spinal) manipulation.
2.2.4. Outcome measures
The trials must have reported at least one patient-rated
outcome measures such as headache pain severity,
frequency, duration, improvement, analgesic use, activities
of daily living, quality of life, functional health status, or
patient satisfaction.
Only full reports were included; abstracts, congress
reports, summaries, and unpublished studies were
excluded. No restriction was made regarding language.
The reviewers were not blinded with regard to the authors,
journal, and institution. Selection criteria were applied, on
the full text of all articles, which had passed the first
eligibility screening. In case of disagreement, it was
resolved through consensus where possible, or arbitration
by a third reviewer (MB).
2.3. Quality assessment
Two reviewers (LD, AV) independently rated the
methodological quality of the included trials using the
Delphi-list (Verhagen et al., 1998) with one extra item (see
Table S1). The assessment was not performed under masked
 M.-L.B. Lenssinck et al. / Pain 112 (2004) 381–388
conditions for feasibility reasons (Jadad et al., 1998). The
Delphi-list is a comprehensive criteria list and is regarded
valid and reliable for the assessment of the methodological
quality of clinical trials (Verhagen et al., 1998, 2001).
It consists of nine methodological criteria: two items related
to the treatment allocation; three items to blinding
procedures; two items to data presentation and analysis;
and two items are related to the eligibility of the study
population and the prognostic comparability of the study
groups. The additional item concerned withdrawal rate,
which was found relevant for these studies. All items have a
‘yes’, ‘no’, or ‘don’t know’ answer option. A score of one
point is given to an item, which is assessed with ‘yes’. Equal
weights were applied to all items, resulting in a maximum
score of 10 points for the overall methodological quality
score, which expresses the overall methodological quality.
In case of a disagreement between the two reviewers,
consensus was used to resolve disagreement. When
consensus could not be reached, a third reviewer made the
final decision (MB).
2.4. Data extraction
Explicit information about patient demographics, type of
headache, type of interventions, type and number of side
effects, outcome measures used, and data on outcome were
recorded using specially designed, pre-tested, standardised
abstracting forms. One reviewer (ML) extracted the data
from each study and another reviewer (LD) over-read the
data extraction.
2.5. Data analysis
First, methodological quality scores (QS) were calcu-
lated as a percentage of the maximum available score. High
quality is defined as six or more criteria fulfilled on the
Delphi-list (Van Tulder et al., 2003). The inter-assessor
agreement was calculated using k scores (O0.7 means a
high level of agreement between assessors; between 0.5 and
0.7 a moderate level of agreement, and !0.5 a poor level of
agreement) (Landis and Koch, 1977).
If possible, the results of each trial were expressed for
dichotomous data as relative risk (RR) with corresponding
95% confidence interval (CI), and for continuous data as
weighted mean differences (WMD) with 95% CI. In case of
clinical heterogeneity (the participants, interventions and
outcome measures were not considered to be sufficient
similar), or if data were lacking, studies were qualitatively
summarised using a ‘best-evidence synthesis’ as described
by Smidt et al. (2002) to distinguish between ‘strong’,
‘weak’ or ‘insufficient’ evidence.
We chose the outcome measurement directly after the
treatment concerning short-term outcome (6–8 weeks).
Concerning long-term outcome, we chose the outcome
measurement closest to 16 weeks.
383
3. Results
3.1. Selection of studies
For an overall review on the treatment of TTH, the search
resulted in 1345 titles and abstracts from MEDLINE, 971
from EMBASE, and 343 from Cochrane. However, 791
publications were included in two or three of the searched
databases, leaving a total of 1868 publications. After the first
eligibility screening, based on titles and abstracts, 418
articles were identified. Of these, 12 publications met our
inclusion criteria (Ahonen et al., 1983, 1984; Boline et al.,
1995; Bove and Nilsson, 1998; Carlsson et al., 1990a–c;
Demirturk et al., 2002; Grunnet-Nilsson and Bove, 2000;
Hanten et al., 1999; Hoyt et al., 1979; Wylie et al., 1997) (see
Fig. 1). Carlsson et al. (1990a–c) compared the same
intervention and control group in three overlapping publi-
cations to different reference groups: a retrospective
reference group (Carlsson et al., 1990a); patients with
craniomandibular disorder (Carlsson et al., 1990c); and
healthy women (Carlsson et al., 1990b). The reference groups
were not analysed in this systematic review. The papers of
Ahonen et al. (1983, 1984) and Bove et al. (Bove and Nilsson,
1998; Grunnet-Nilsson and Bove, 2000) concerned dual
publications leaving a total of eight trials, which were
included in this review. One of the publications of Bove et al.
was written in Danish (Grunnet-Nilsson and Bove, 2000).
Quality assessment and data extraction was performed on
all publications.
3.2. Methodological quality
The two assessors (LD, AV) initially agreed on 92% of
the quality items. Disagreement was solved under con-
sensus. The inter-observer reliability of the methodological
quality assessment (kZ0.85) was high. In Table S2, detailed
results of the methodological quality scores are presented.
Only two studies were considered to be of high quality,
because they received a quality score of 6 or more points
(Boline et al., 1995; Bove and Nilsson, 1998). One of them
also described a concealed randomisation procedure and an
adequate blinding (Bove and Nilsson, 1998). The overall
methodological quality score of all included studies ranged
from 1 to 8 out of maximal 10 points (median score: 4),
indicating an overall poor methodological quality. The most
prevalent shortcomings of the trials concerned: no con-
cealed treatment allocation procedure (nZ6); no presen-
tation of baseline comparability (nZ5); no attempt to blind
the care provider (nZ8); or the patient (nZ7); no adequate
description of withdrawals (nZ5) or the analysis did not
include an intention-to-treat analysis (nZ7).
3.3. Study characteristics
Table S3 gives a short description of the study design,
study population, interventions, outcome measures used,
and results.
384 M.-L.B. Lenssinck et al. / Pain 112 (2004) 381–388
Fig. 1. Flow chart of selection process.
In total, 466 patients were included in the eight trials.
Four studies reported dropouts; the mean percentage of
dropouts was 13.7% (range 6.7–16.1%). The size of the
study groups ranges from 6 to 75. In five studies, all
treatment groups were smaller than 25 patients, indicating
low power for detecting clinically relevant differences
(Ahonen et al., 1984; Demirturk et al., 2002; Hanten et al.,
1999; Hoyt et al., 1979; Wylie et al., 1997). In seven studies,
information on age or gender was given; in these studies,
the mean age was 38 years, and overall, the percentage
of women was higher than men (mean 73%; range
52.5–100%). Five trials (Boline et al., 1995; Bove and
Nilsson, 1998; Demirturk et al., 2002; Hanten et al., 1999;
Wylie et al., 1997) used the criteria of IHS (1988) to classify
TTH, one trial (Carlsson et al., 1990b) used the criteria
according to Ad Hoc Committee on Classification of the
NIH (1962) while the other two studies used none of these
classifications (Ahonen et al., 1984; Hoyt et al., 1979).
Several interventions were used in the studies, ranging
from chiropractic spinal manipulation, connective tissue
manipulation, osteopathic manipulation, CV4 technique
(a type of manual therapy). Physiotherapy consisted of
combinations of parafango, massage, ultrasound, relaxation
techniques, cryotherapy, etc. Comparison groups included
acupuncture, deep friction massage with mobilisation,
palpation, rest, and in one study a placebo was used: low
power laser light.
The included studies showed a wide range of outcome
measures. The most prevalent outcome measures were
headache frequency, headache intensity, headache
severity, headache index, use of medicine and EMG
activity. Headache index was calculated by multiplication
of the frequency of headache with the severity of pain.
Emotional state and mental well-being were reported twice
(Boline et al., 1995; Carlsson et al., 1990b).
In five studies (Ahonen et al., 1984; Boline et al., 1995;
Bove and Nilsson, 1998; Carlsson et al., 1990b; Demirturk
et al., 2002), a follow-up period was included, ranging from
short-term follow-up (!3 months) to long-term follow-up
(3 months–1 yr.).
 M.-L.B. Lenssinck et al. / Pain 112 (2004) 381–388
3.4. Description of the individual trials
3.4.1. Effectiveness of trials with high quality
Two studies were considered to be of high quality. The
study of Boline et al. (1995) compared chiropractic spinal
manipulation with a control group, receiving medication
(amitriptyline). At the end of the 6-week treatment period,
there were no clinically important or statistically significant
differences between the two treatment groups; they both
improved at similar rates. The amitriptyline group showed
more improvement in headache intensity, but was associ-
ated with more side effects. According to the authors, there
were significant differences between the groups in favour
of the spinal manipulation group in all four major
outcome measures, 4 weeks after the end of the intervention
(week 12), based on a worst-case analysis. Because of a lack
of information, we were unable to re-calculate these
findings.
In the study of Bove et al. (Bove and Nilsson, 1998),
chiropractic spinal manipulation therapy was compared to a
placebo laser treatment. All patients received deep friction
massage. Mean number of headache hours a day and
analgesic use showed improvement in both groups from pre-
treatment to week 7. We as well as the authors found that the
mean number of headache hours was reduced, but there
were no significant difference between the groups. Head-
ache intensity was unchanged for the duration of the trial.
3.4.2. Effectiveness of trials with low quality
Three studies evaluated the effect of physiotherapy
compared to acupuncture (Ahonen et al., 1984; Carlsson
et al., 1990b; Wylie et al., 1997). Two of these studies
concluded that both physiotherapy and acupuncture
achieved improvement for TTH, but the improvement was
most pronounced (although not statistically significant) in
the physiotherapy group regarding reducing the intensity
and frequency of headache, facial pain, and muscle
tenderness (Carlsson et al., 1990b; Wylie et al., 1997). In
the study of Wylie et al. (1997), there was a difference in
pain ratings in favour of the massage and relaxation group.
Ahonen et al. (1984) concluded that similar decrease in
surface EMG activity and pain relief could be achieved by
physiotherapy and acupuncture. The various studies
used different kinds of physiotherapy and acupuncture, so
the studies were not comparable regarding interventions
(see Table S3).
Three other studies evaluated a form of manipulation. In
the study of Hanten et al. (1999), a significant improvement
in the intensity and the affective component of pain occurred
in the group receiving CV4 technique, while no significant
improvement occurred in the resting position and the no-
treatment group. The differences between the groups were
not statistically significant. In the study of Hoyt et al.
(1979), the authors claim that the combination of palpatory
examination and manipulative procedures was statistically
superior to either palpatory examination alone or to resting
385
in the supine position in the reduction of the rated headache
severity, but no data were availables.
Demirturk et al. (2002) compared a form of manipulation
with physiotherapy and found significant improvements for
all of their outcome measures by connective tissue
manipulation as well as Cyriax mobilisation therapy. No
between group differences were found.
3.5. Evidence of effectiveness
The studies in this review were not clinically comparable
with each other concerning interventions, study population,
treatment duration, and outcome measures. Because of this
heterogeneity we refrained from statistical pooling and
performed a ‘best-evidence synthesis’ (see Fig. 2). The
grey-coloured cells show the route through the best-
evidence synthesis.
According to our best-evidence synthesis, there is
insufficient evidence to either support or refute the
effectiveness of physiotherapy and (spinal) manipulation
compared to other treatments, due to low quality scores of
almost all studies, a wide range of outcome measures, and
inconsistent results of the individual studies (see Fig. 2).
Only two studies on chiropractic spinal manipulation
compared to other treatments achieved a high quality
score, but showed inconsistent results (insufficient evi-
dence) (Boline et al., 1995; Bove and Nilsson, 1998).
3.6. Side effects
Only two studies reported side effects (Boline et al.,
1995; Carlsson et al., 1990b). The study of Boline et al.
(1995) provided information on the side effects of
chiropractic spinal manipulation and amitriptyline. In
proximally 4% of the patients receiving spinal manipulation
side effects like short-term neck soreness and stiffness were
reported after the first treatment. More than half of the
patients in the amitriptyline group reported side effects such
as dry mouth, drowsiness and weight gain. Side effects of
acupuncture were reported in the study of Carlsson et al.
(1990b). A slight vasovagal reaction was seen in a few
patients at the first treatment.
4. Discussion
Based on the results of our systematic review, there is
insufficient evidence to draw firm conclusions on the
effectiveness of physiotherapy and (spinal) manipulation
for TTH.
Our review may suffer from several shortcomings. One
possible shortcoming of this systematic review is that
predominantly studies with small sample sizes were
available for inclusion in this review. The number of
patients in the study groups was often too small to reach an
adequate statistical power; only three studies had study
386 M.-L.B. Lenssinck et al. / Pain 112 (2004) 381–388
Fig. 2. Best-evidence synthesis (Smidt et al., 2002).
groups with over 25 patients included. Another shortcoming
is the overall heterogeneity of the studies. There appeared to
be many differences in study populations, interventions,
treatment duration, and outcome measures. The methodo-
logical quality of the majority of the studies was low. Only
two studies were regarded of high quality. There is,
however, a difficulty in blinding the care provider and the
patients during spinal manipulation and physiotherapy
treatment of TTH.
Misclassification of the methodological quality might
also be a possible shortcoming in this review. We assume
that the risk of misclassification is small, because we used
a valid and reliable criteria list (Verhagen et al., 2001). If
we had used a second definition for high quality, namely,
there had to be a concealed randomisation procedure and
an adequate blinding presented (Moher et al., 1996), then
there were no major differences found in the selection of
high quality studies, and therefore, we assume the risk of
misclassification is probably small. In every review, there
are also risks of publication and language bias, but
because of our extensive search strategy without any
language restriction, we believe this risk is also small in
our review.
Chronic headaches affect different aspects of daily life.
In a report of lifetime headache histories in volunteers,
40–50% of them experienced severe headaches that
rendered them unable to work (Schwartz et al., 1997).
Headache has a great impact on quality of life. Therefore, it
is important that outcome measures include a quality of life
measurement or a functional health status. Most studies
included in this review, however, did not address these kinds
of outcome measures. Only twice functional health status,
mental well-being and emotional state were measured
(Boline et al., 1995; Carlsson et al., 1990b).
From a systematic review, it is known that in
approximately half of the patients who underwent spinal
manipulation, mild to moderate transient side effects
occurred (Ernst, 2001). Serious complications of spinal
manipulation seem to be rare, but no reliable data about the
incidence exists (Ernst, 2001). In our review, minor short-
term side effects were reported only twice (Boline et al.,
1995; Carlsson et al., 1990b).
Several reviews on diagnostic, pathophysiologic mech-
anisms and treatments in (tension-type) headache have been
performed (Astin and Ernst, 2002; Bogaards and ter Kuile,
1994; Bronfort et al., 2001; Hurwitz et al., 1996; Jensen,
1999; Smetana, 2000; Vernon et al., 1999) Two systematic
reviews have been performed on spinal manipulation for
various primary headaches (Astin and Ernst, 2002; Bronfort
et al., 2001). The review of Astin and Ernst (2002) included
eight RCTs, of which only three trials evaluating the effect
of chiropractic and osteopathic manipulation for TTH
(Boline et al., 1995; Bove and Nilsson, 1998; Hoyt et al.,
1979). They concluded that, despite claims that spinal
manipulation is an effective treatment for headache, the data
available do not support such definitive conclusions. The
review of Bronfort et al. (2001) reported on nine RCTs for
chronic primary headache, in which the same three trials on
TTH were included. They concluded that there is moderate
evidence that spinal manipulation therapy has short-term
efficacy comparable with amitryptiline in the prophylactic
treatment of chronic-TTH and migraine. The conclusions of
 M.-L.B. Lenssinck et al. / Pain 112 (2004) 381–388
these two systematic reviews are inconsistent, and do not
draw conclusions on the effectiveness of (spinal) manipu-
lation in patients with TTH specifically.
In the systematic review of Hurwitz et al. (1996), five
RCTs, 10 case series, and 19 case reports were identified
that assessed the effectiveness of cervical spine manipu-
lation and mobilisation for primary headache and neck pain.
Only three RCTs included patients with TTH (Boline et al.,
1995; Carlsson et al., 1990b; Hoyt et al., 1979). The
reviewers concluded that manipulation or mobilization
might be beneficial for muscle tension headache.
One systematic review has been reported on comp-
lementary medicine/alternative therapies, like acupuncture,
spinal manipulation, electrotherapy, physiotherapy,
homeopathy, and tiger balm, in the treatment of non-
migrainous headache (tension-type and cervicogenic head-
ache combined) (Vernon et al., 1999). The authors reviewed
24 RCTs, in which only five trials reported on physiotherapy
and manipulations for TTH (Ahonen et al., 1984;
Boline et al., 1995; Bove and Nilsson, 1998; Carlsson
et al., 1990b,c; Hoyt et al., 1979) including one overlapping
publication of Carlsson et al. (1990b,c). They concluded
that the efficacy of both physiotherapy and manipulations
for TTH or cervicogenic headache could not be determined.
The methodological quality of these four systematic
reviews ranged from moderate to sufficient when evaluated
using a checklist of the Dutch Cochrane Centre. The most
prevalent shortcomings of the systematic reviews con-
cerned: language restriction (English only) (Hurwitz et al.,
1996; Vernon et al., 1999), selection procedure unknown
(Astin and Ernst, 2002; Bronfort et al., 2001), and unclear
review methods (Astin and Ernst, 2002; Hurwitz et al.,
1996).
The conclusions of two reviews did not focus on patients
with TTH alone (Astin and Ernst, 2002; Bronfort et al.,
2001), and the conclusions of two other reviews that did
report on TTH were inconsistent in their findings (Hurwitz
et al., 1996; Vernon et al., 1999). Therefore, we performed a
more valid systematic review on the effectiveness of
physiotherapy and (spinal) manipulation, primary focussing
on TTH alone. Contrary to the previous reviews, we did not
apply language restriction, presented a transparent selection
procedure and a clear methodology according to the high
standards of the Cochrane Collaboration and only RCTs
were included in this study.
In conclusion, the relatively small number of identified
RCTs, high degree of heterogeneity, overall poor methodo-
logical quality, and overall small sample sizes of the
included studies, makes it not possible to draw valid
conclusions on the effectiveness of physiotherapy and
(spinal) manipulation in patients with TTH. There is
insufficient evidence to either support or refute the
effectiveness of physiotherapy and (spinal) manipulation
in patients with TTH. Well-designed trials of sufficient size
with long-term follow-up are needed to provide the
evidence concerning the use of physiotherapy and (spinal)
387
manipulation in the treatment of patients with TTH. We
agree that in future research outcome measures should also
include a quality of life assessment, functional health status,
patient satisfaction, and side effects.
Appendix. Supplementary Material
Supplementary data associated with this article can be
found, in the online version, at doi:10.1016/j.pain.2004.
09.026.
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