Journal of Oral Rehabilitation 2006 33; 713–721
Treatment outcome of short- and long-term appliance
therapy in patients with TMD of myogenous origin and
tension-type headache
E. C. EKBERG & M. NILNER Department of Stomatognathic Physiology, Faculty of Odontology, Malmö University, Malmö,
Sweden
SUMMARY The aim was to compare the short- and
long-term effect of a stabilization appliance with a
control appliance in myofascial pain patients
suffering from episodic or chronic tension-type
headache. Sixty patients (mean age 29  12 years)
with temporomandibular disorders (TMD) of
myogenous origin and headache were studied in
this prospective controlled study. Seventy-seven
per cent of the patients reported episodic and 23%
chronic tension-type headache at the start of the
study. The 60 patients were randomly assigned to
a treatment group (stabilization appliance) or to a
control group (control appliance). The patients
were interviewed regarding symptoms of headache
and myofascial pain and clinically examined for
masticatory muscle tenderness. At the 10-week
and the 6- and 12-month evaluations of appliance
therapy, the treatment outcome of tension-type
headache was studied. At the 10-week evaluation,
Introduction
Tension-type headache is prevalent, and the 1-year
prevalence of this type of headache has been reported
to range from 30% to about 80% in the general
population in North America and Western Europe (1).
It is a major cause of suffering and lost work (2).
Epidemiological studies have found associations be-
tween temporomandibular disorders (TMD) and head-
ache (3–9). Tension-type headache has often been
reported by patients suffering from TMD and found in
up to 40–50% among both children and adolescents
(10–12). Among adult patients referred for treatment of
ª 2006 Blackwell Publishing Ltd
17 patients dropped-out from the control group by
requesting another appliance and receiving a sta-
bilization appliance. Another patient in the control
group dropped out later during the trial. In an
intent-to-treat analysis, significant differences in
improvement of headache between treatment and
control groups were found at the follow-ups. A
30% reduction of muscles tender to palpation
correlated significantly to improvement of head-
ache at all follow-ups. The stabilization appliance
seems to have a positive effect on tension-type
headache, both in a short- and in a long-term
perspective in patients with TMD with pain of
myogenous origin.
KEYWORDS: headache, long-term follow-up, myofas-
cial pain, stabilization appliance, temporomandibu-
lar disorders
Accepted for publication 24 April 2006
TMD, headache has been reported in more than 70%
(13, 14). No clear casual relationship between tension-
type headache and TMD has been found, but one
reason for the association could be that both disorders
are highly prevalent. Of the signs common to TMD only
masticatory muscles painful to palpation have consis-
tently been found to have a relationship to tension-type
headache (15).
Previous studies of occlusal therapy have presented
positive treatment effect on tension-type headache in a
short-term perspective (4, 16–19). Occlusal therapy in
a longer perspective has also been reported to have a
positive treatment outcome on tension-type headache
doi: 10.1111/j.1365-2842.2006.01659.x
714 E. C. EKBERG & M. NILNER
(19–21). However, occlusal adjustment as a single
treatment did not have an acceptable treatment effect
but in combination with appliance therapy the treat-
ment effect improved (19–21). There is only one study
evaluating the long-term effect of a treatment with a
stabilization appliance. In a controlled study, Ekberg
et al. (13) showed that the stabilization appliance
seemed to have an effect on the frequency of tension-
type headache in patients with TMD pain of mainly
arthrogenous origin.
In a randomized-controlled trial (RCT), the efficacy of
treatment with a stabilization appliance was tested in
patients suffering from TMD of mainly myogenous
origin. The treatment outcome was favourable for the
stabilization appliance in both a short- and a long-term
perspective regarding patients’ complaints of TMD (22,
23). The aim of this study was therefore to examine the
efficacy of treatment with a stabilization appliance on
tension-type headache in these TMD patients who also
suffered from tension-type headache in a short- as well
as a long-term perspective of 1 year.
The hypothesis was that the occurrence of an
improvement was greater in patients with TMD pain
of myogenous origin treated with a stabilization appli-
ance than in those treated with a control appliance in a
short- but not in a long-term perspective.
Materials and methods
A statistical power calculation revealed that 60 patients
would be needed to obtain a statistical power of slightly
above 90% and significance at the 5% level in a two-
tailed test if the true success probabilities of overall
symptoms were 70% in the treatment (T) and 30% in
the control (C) group. Sixty TMD patients were there-
fore selected and randomly assigned to these two
groups.
The patients (52 women and eight men, mean age
29  12 years) had TMD of mainly myogenous origin
and were selected from 926 consecutive patients
referred for treatment of TMD between February 1998
and April 2000 to the Department of Stomatognathic
Physiology, Faculty of Odontology, Malmö University.
All patients referred for TMD pain (338) were clinically
screened. Only patients with a history of pain from the
masticatory muscles that was verified in an interview
and a clinical examination, combined with self-assessed
myogenous pain at worst of at least 40 mm on a visual
analogue scale (24) were included in the study. The
ª 2006 Blackwell Publishing Ltd, Journal of Oral Rehabilitation 33; 713–721
inclusion criteria were pain of muscular origin with or
without limited opening, including a complaint of pain
associated with localized areas of tenderness to palpa-
tion in the masticatory muscles; a clinical diagnosis of
myofascial pain with or without limited opening
according to Dworkin and LeResche (25); and a
classification of chronic or episodic tension-type head-
ache according to the International Headache Society
(26). No neurological evaluation was performed.
After receiving information about the project, all
participating patients gave their consent. The Ethics
Committee of Lund/Malmö approved the study. The
60 patients were then assigned to one of two groups:
group T (30 patients, treatment with a stabilization
appliance) or group C (30 patients, treatment with a
control appliance). One independent person carried out
the randomization by using 10 series of consecutively
numbered, sealed opaque envelopes. Each envelope
contained a treatment specification (27). This procedure
was repeated until 60 patients were found for the study.
As can be seen in the flow chart of the study (Fig. 1),
the patients who reported a negative treatment out-
come or discomfort associated with the use of the
appliances at the follow-ups either had their appliances
readjusted or were given a new appliance. After the
10-week follow-up, one patient in group C was with-
drawn because the patient no longer wished to parti-
cipate and another 17 patients in group C were
withdrawn because they were dissatisfied with the
control appliance and desired other treatment. After the
6-month follow-up, two more patients in group C
requested other treatment.
In this controlled trial, one TMD specialist (A), calib-
rated to research diagnostic criteria for TMD (RDC/
TMD), performed the screening, history taking and
clinical examination. After randomization by a dental
assistant who was not otherwise involved in the project,
another specialist (B) handed out, adjusted and read-
justed the appliances. Specialist A, who had no informa-
tion about which group the patients had been assigned
to, evaluated the treatment outcome at 10 weeks,
6 months and 12 months after treatment.
The main outcome measures were reported fre-
quency of headache and overall improvement of
headache. The base-line and follow-up questionnaires
included questions about frequency of headache and
myofascial pain, which were to be answered using a
verbal scale as follows: 1 ¼ rarely, 2 ¼ once every
second week, 3 ¼ once a week, 4 ¼ several times a
 TREATMENT OUTCOME OF SHORT- AND LONG-TERM APPLIANCE THERAPY 715

Visits Patients Examiner were asked to verbally assess how often they used
1 60 A their appliance: every night, several nights a week,
when necessary and not at all.
The clinical examination before and after treatment
Group T Group C Drop-outs
included palpation of the masticatory muscles. The
2 30 30 B following muscles were palpated: the temporal muscle,
the masseter, the lateral pterygoid, and the subman-
3 30 30 B dibular and posterior mandibular regions. The muscles
were palpated manually before and after treatment by
the same examiner. The degree of tenderness was
4 30 30 A
evaluated on a 4-point scale: 0 ¼ no tenderness,
1 ¼ tenderness reported by the patient, 2 ¼ tender-
ness with a palpebral reflex and 3 ¼ tenderness with a
5 30 12 18 B
defence reaction. These clinical variables have been
found to be reliable with kappa values from acceptable
6 30 12 18 A to good levels (28, 29).
The stabilization appliance used by the patients in
7 30 10 20 B group T had a smooth flat surface that was in contact
with all supporting teeth. The end-point on the appli-
8 30 10 20 A ance was centric relation achieved by chin-point
guidance. The stabilization appliance was equipped
Visit 1: Base-line
Visit 2: Appliance was handed out after adjustment with cuspid rise to avoid interferences at mediotrusion
Visit 3: Readjustment of appliances and laterotrusion. During protrusion the appliance had
Visit 4: 10-week follow-up
Visit 5: Adjustments, readjustments. Drop-outs received other treatment
contacts between cuspids.
Visit 6: 6-month follow-up The control appliance used by patients in group C
Visit 7: Adjustments, readjustments. Drop-outs received other treatment was designed with palatal coverage and clasps on
Visit 8: 12-month follow-up
Examiners A and B are TMD specialists maxillary teeth and did not alter the intermaxillary
relationship. Both groups were instructed to use the
Fig. 1. Distribution of temporomandibular disorder patients at
appliances at night for a period of at least 10 weeks, and
base-line and at the 10-week, the 6-month, and the 12-month
follow-ups in all patient groups [T (treatment group) and C
after this time, the patients were free to use the
(control group)]. appliances when necessary.
The patients were informed about the lack of an
week and 5 ¼ daily. The follow-up questionnaire unambiguous cause of TMD and about contributing
included an overall subjective evaluation of headache factors (30). The patients were reassured and informed
assessed verbally on a 6-point scale: symptom-free, about the nature of their TMD, the relationship
much better, better, unchanged, worse and much between headache and TMD, and the psycho-physio-
worse. The headache was judged to be improved when logical aspects of stress. The patients were also instruc-
the patient reported it to be better, much better, or ted in how to self-monitor TMD symptoms, both at start
symptom-free. The questionnaires also asked about and at 10 weeks, 6 months and 12 months.
the duration of the tension-type headache. The The chi-squared test was used to compare the distri-
intensity of worst experienced myofascial pain was bution of variables in different groups of patients on a
registered at start and after 10 weeks, 6 months and nominal scale at the 10-week follow-up. The McNemar
12 months. Reported awareness of grinding or clench- test was used to compare the distribution of categorical
ing, and pain from the neck were registered. Psycho- variables. This test was used to determine the significance
social factors asked for were number of other pain of differences within groups (27). A backward stepwise
regions, medication for other pain, sick leaves during logistic regression with the likelihood ratio test was used
the year, trauma, chronic pain in family, unemploy- when analysing influencing factors for the treatment
ment, divorce, close relative sick or dead and stressful outcome. Differences at the 5% level of probability were
life events. At the different follow-ups, the patients considered statistically significant.

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716 E. C. EKBERG & M. NILNER

Results Table 2. Psycho-social factors before treatment in patients in the

treatment (T) and control (C) groups

Base-line
T group C group
There were no differences in signs, symptoms or (n ¼ 30) (n ¼ 30)
psycho-social factors between T and C groups before n % n %
treatment (P > 0.05) (Tables 1 and 2).
Psycho-social factors
Seventy-seven per cent of the patients reported
Other pain regions in the body 17 57 16 53
episodic and 23% chronic tension-type headache at Medication towards other pain 9 30 7 23
the start of the study. Sick-leave during the year 11 37 8 27
Trauma 5 17 4 13
Unemployed 5 17 7 23
Table 1. Distribution of age, gender, signs and symptoms in Divorced 8 27 8 27
temporomandibular disorder (TMD) patients with myofascial pain Close relative sick or dead 15 50 16 53
before treatment in the treatment (T) and control (C) groups Any kind of stressful life events 18 60 20 67

T (n ¼ 30) C (n ¼ 30)

n % n %
A history of headache >6 months was reported by
Age (years) 57% of the patients in group T and by 63% of the
<20 4 13 7 23 patients in group C.
20–40 19 64 18 60
>40 7 23 5 17
Gender 10-week follow-up
Females 25 83 27 90
Males 5 17 3 10 Compared with base-line, a statistically significant
Symptoms difference was found within group T regarding number
Frequency of headache
of patients reporting tension-type headache at least
Rarely 4 13 7 23
Once every second week 4 13 2 7
once a week (14 patients) (P ¼ 0.039) and daily (three
Once a week 6 20 10 33 patients) (P ¼ 0.031).
Several times a week 7 23 6 20 Twenty-five patients from group T and 13 patients
Daily 9 30 5 17 from group C reported improvements in their head-
Frequency of myofascial pain ache; the between-group difference was significant
Rarely 0 0 0 0
(P ¼ 0.003, Fig. 2). Fifty-seven per cent of the
Once every second week 1 3 5 7
Once a week 0 0 0 0 patients with improved headache in group T had
Several times a week 6 20 8 27 also a 30% reduction in the number of tender
Daily 23 77 20 66 masticatory muscles compared with 30% in group
Intensity of myofascial pain C; the between-group difference was significant
Slight 1 3 1 3
(P ¼ 0.037) (Fig. 2).
Moderate to very severe 29 97 29 97
Severe or very severe 14 47 17 57
Eighty-three per cent of the patients in group T and
Awareness of grinding 24 80 25 83 77% in group C reported that they used their appliance
and clenching several nights a week or more.
Pain from the neck 13 43 15 50
Unilateral 3 10 8 27
Bilateral 10 33 7 23 6-month follow-up
Signs
Masticatory muscles A significant reduction in the number of patients with
Degree of tenderness headache at least once a week was found in group T but
1–2 27 90 25 83 not in group C (14 patients) (P ¼ 0.039) at this follow-
3 3 10 5 17 up.
3 Tender sites 8 27 2 7
In an intent-to-treat analysis of reported improve-
‡4 Tender site 22 73 28 93
ment in tension-type headache, a significant difference

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 TREATMENT OUTCOME OF SHORT- AND LONG-TERM APPLIANCE THERAPY 717

No. of patients
30
Fig. 2. Number of patients reporting
improvement in tension-type head- 25
ache (———) and number of
patients having both a 30% reduc- 20
tion in number of tender muscles to T
palpation and an improvement of C
15
headache (– – –) in the treatment (T) T
and in the control (C) groups at the C
10
10-week and the 6- and 12-month
follow-ups. The change in headache
was judged to be positive when the 5
patients reported themselves to be
better, much better, or symptom- 0
free. Baseline 10 weeks 6 months 12 months

was found between groups T and C (P ¼ 0.001)

(Fig. 2). Seventy-three per cent of the patients in group
T, and 75% in group C reported improvements in their
headache.
A 30% reduction in the number of tender mastica-
tory muscles was found in 63% of the patients with
improved headache in group T compared with 34% in
group C; the between-group difference was significant
(P ¼ 0.006) (Fig. 2).
In groups T and C, the frequencies of the patients
using their appliance several nights a week or more
were 63% and 67% respectively.
Influencing factors
A backward stepwise logistic regression analysis with
headache (improved/not improved) as the outcome
factor was performed (Table 3). When testing the
treatment outcome of headache we found a significant
difference between the treatment and the control group
(P ¼ 0.011) at the 10 weeks follow-up. Having a 30%
improvement of muscles tender to palpation was a
factor which influenced the treatment outcome at all
follow-ups. At 12 months follow-up it was found that
reported any kind of stressful life-events at baseline
influenced the treatment outcome.

12-month follow-up
The number of patients with headache once a week or
more decreased significantly in group T (11 patients)
(P ¼ 0.003).
When comparing groups T and C regarding reported
improvement in tension-type headache in an intent-
to-treat analysis, a significant difference was found
(P ¼ 0.010) (Fig. 2). Sixty-three per cent of the patients
in group T, and all patients in group C reported
improvement in their headache.
A 30% reduction in number of tender masticatory
muscles was found in 50% of the patients with
improved headache in group T compared with 27% in
group C; the between-group difference was non-signi-
ficant (Fig. 2).
Fifty-seven per cent of the patients in the T group and
33% in the C group used their appliance several nights
a week or more.
Discussion
The hypothesis of the study could be confirmed in a
short- but not in a long-term perspective. The
treatment outcome of this prospective and controlled
study evaluating the stabilization appliance as a
treatment modality for tension-type headache in
TMD patients showed a favourable result for the
stabilization appliance. More than 60% of the
patients reported improvement in their headache
both in a short- and in a long-term perspective. The
result of our study was well in accordance with
previous studies (19–21).
It has to be kept in mind that spontaneous (31) and
natural fluctuations in the condition, as well as the
placebo effect (32), are factors important for a positive
treatment outcome. It is emphasized that group C in
our study decreased markedly in number. The positive

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718 E. C. EKBERG & M. NILNER

Table 3. Backward stepwise logistic regression analysis of the treatment effect at 10 weeks, 6 months and at 12 months after correcting
for eight possible influencing factors

Initial model Final model

OR CI (P) L CL (P)

10 weeks (n ¼ 60)
Group (treatment) 14.284 1.675–121.790 0.004 )26.856 6.420 0.011
Sex (female) ¥ 0.005–¥ 0.028
Age (20–40 years) 0.229 0.031–1.710 0.134
Severe or very severe myofascial pain 0.249 0.032–1.955 0.163
Other pain regions in the body 0.705 0.451–1.102 0.078
Any kind of stressful life events 4.706 0.568–39.005 0.123
Improvement 30% of muscles tender to palpation ¥ 0.000–¥ 0.000 )34.044 20.796 0.000
Using appliance several nights a week or more 0.877 0.117–6.594 0.899

6 months (n ¼ 58)
Group (treatment) 10.894 0.383–310.010 0.127
Sex (female) ¥ 0.000–¥ 0.346
Age (20–40 years) 0.135 0.005–4.017 0.214
Severe or very severe myofascial pain 0.155 0.005–5.176 0.271
Other pain regions in the body 1.050 0.669–1.649 0.832
Any kind of stressful life events 0.665 0.044–10.125 0.769
Improvement 30% of muscles tender to palpation ¥ 0.000–¥ 0.000 )40.064 56.287 0.000
Using appliance several nights a week or more 0.949 0.035–25.732 0.975

12 months (n ¼ 58)
Group (treatment) 4.906 0.10–230.697 0.386
Sex (female) ¥ 0.000–¥ 0.117
Age (20–40 years) 0.125 0.005–3.180 0.178
Severe or very severe myofascial pain 0.559 0.035–8.825 0.675
Other pain regions in the body 0.700 0.418–1.172 0.091
Any kind of stressful life events ¥ 0.000–¥ 0.009 )16.035 4.516 0.034
Improvement 30% of muscles tender to palpation ¥ 0.000–¥ 0.000 )40.056 52.558 0.000
Using appliance several Nights a week or more 0.909 0.010–79.221 0.967

Dependent variable: treatment outcome of tension-type headache.

OR, odds ratio with 95% confidence intervals (CI); L, log likelihood; CL, change in )2 log likelihood.

treatment outcome in this group corresponded more to
a placebo effect than to a therapeutic effect as only 10
patients out of original 30 had a positive treatment
outcome at the 12 months follow-up. Another explan-
ation to mechanisms of appliance therapy is the effect
on sleep bruxism. In a newly published article it was
found that neither occlusal appliance nor palatal splints
had an influence on sleep bruxism (33). However, the
sleep bruxism in that study was not correlated to TMD
pain or tension-type headache.
One limitation of this study was the high number of
drop-outs in the control group. The patients were not
motivated to continue with the treatment. Another
limitation was the limited number of patients with a full
recovery from headache, but just reporting themselves
to be better probably enhanced their quality of life.
Pain of tension-type headache has been suggested to
be of central origin (34), the more traditional interpre-
tations, however, have stated that the pain could arise
from local structures such as the muscles of the scalp
(35). Manual palpation is by far the most widely used
method to evaluate myofascial pain sensitivity in
patients with tension-type headache, both in the clinic
and in the laboratory (36). The prevalence of recurrent
headaches in a group of TMD patients has previously
been reported to be higher than in a group of dental
patients. The treatment directed towards functional
disturbances of the masticatory system had a beneficial
effect. Patients suffering from recurrent headaches
experienced a reduction in the frequency of their
headaches after treatment (37). In studies of patients
suffering from tension-type headache, migraine and a

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 TREATMENT OUTCOME OF SHORT- AND LONG-TERM APPLIANCE THERAPY
combination of both, treatment with occlusal adjust-
ment, occlusal appliance, or both was found to have an
effect specifically on tension-type headache (17–19).
In the literature, it has been discussed why tension-
type headache is more common than myofascial pain
from other parts of the body (38). Factors discussed are
that pain thresholds to pressure are lower in the
cranium than in the extremities and a general lowering
of pain thresholds can result in pain from the head but
not from the rest of the body; that the head has a
central role in body awareness; that the cortical
representations of both the head and the face are large
compared with other parts of the body; and, as
proposed by Jensen and Graff-Radford (15), that
morphologic and articular disorders have no or, at
most, an uncertain relation to headache.
In an RCT similar to this, however, a stabilization
appliance was found to have an effect on the frequency
of tension-type headache both in a short and in a longer
perspective of 12 months in TMD patients of mainly
arthrogenous origin (13). Patients in that study suffered
from temporomandibular joint (TMJ) pain in combi-
nation with myofascial pain except for two patients
who only suffered from TMJ pain. The results from that
study were in accordance with the results of this.
It has been reported that behaviour and psychological
distress are important factors in treatment outcome in
TMD patients (39). TMD patients have been reported to
be more distressed than healthy individuals (40), but
depression and anxiety also play an important role in
the perception of pain (41, 42). In a longitudinal study
of TMD patients, Rammelsberg et al. (43) found that
somatization was a factor of importance for developing
myofascial pain. In patients visiting their doctor for
aggravating tension-type headache, it has been fre-
quently found that psychological stress, daily irritations,
muscle strain, anxiety and depression are influencing
factors. Major life events, however, did not occur more
often in patients suffering from headache compared
with controls (44). However, in our study the reported
any kind of stressful life events, which could be
interpreted as major life events, seemed to influence
the treatment outcome of headache at the 12 months
follow-up. This could be explained by that the patients
during this period of time better understood the
relationship between tension-type headache and stress
and the more acute phase of the stressful life events had
disappeared. Minor life events such as daily irritations
were not studied.
ª 2006 Blackwell Publishing Ltd, Journal of Oral Rehabilitation 33; 713–721
719
In a 20-year longitudinal study it was found that
women reported TMD symptoms and headache more
often than men (45). The number of patients included
in our study was selected from patients referred to the
specialist clinic at the Faculty of Odontology in Malmö
for treatment of TMD pain and headache. An overrep-
resentation of women was also found in our study.
Of the signs common to TMD, only masticatory
muscles painful to palpation have consistently been
found to have a distinct relationship to headache (15).
Therefore it was of great interest to study how muscles
tender to palpation correlated to treatment outcome at
all follow-ups. The 30% reduction of muscles tender to
palpation correlated significantly to the treatment
outcome of headache at all follow-ups in our study.
This finding indicates a relationship between tension-
type headache and soreness in the masticatory muscles.
The result of this study shows that the stabilization
appliance seems to have a positive effect of tension-type
headache, both in a short- and in a long-term perspec-
tive, in patients with TMD of mainly myogenous origin.
In our study, a reduction in the number of masticatory
muscles tender to palpation in connection with reduced
frequency of headache was seen. These findings could
be one explanation for the efficacy of the stabilization
appliance in patients with TMD pain of myogenous
origin in connection with tension-type headache. Based
on the findings in this study the stabilization appliance
can therefore be recommended as a palliative treatment
in patients with a combination of tension-type head-
ache and myofascial pain.
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Correspondence: Dr EwaCarin Ekberg, Department of Stomatognathic
Physiology, Faculty of Odontology, Malmö University, SE-205 06
Malmö, Sweden.
E-mail: ewacarin.ekberg@od.mah.se