ORIGINAL ARTICLE

Biofeedback-based Cognitive-Behavioral Treatment

Compared With Occlusal Splint for
Temporomandibular Disorder
A Randomized Controlled Trial
Meike C. Shedden Mora, PhD,* Daniel Weber, DDS,w Andreas Neff, PhD,z
and Winfried Rief, PhD*

Cognitive-behavioral therapy (CBT) for TMD successfully

Objectives: Cognitive-behavioral treatment has proven efficacy reduces pain, pain-related disability and increases pain cop-
for chronic temporomandibular disorder (TMD). However, most ing skills by enhancing adaptive cognitions and behaviors.2–6
patients receive dental treatment that may not address psycho- In order to address pathophysiologic mechanisms, CBT has
logical comorbidities often present in TMD. The aim of the present
study was to evaluate the efficacy of biofeedback-based cognitive-
been successfully combined with biofeedback, which leads to
behavioral treatment (BFB-CBT) versus dental treatment with oc- substantial long-term improvements in pain and symp-
clusal splint (OS). Moreover, changes in nocturnal masseter muscle toms.7,8 Biofeedback for TMD aims to improve proprio-
activity (NMMA) were investigated. ceptive awareness of oral parafunctions and to re-
duce mandibular muscle hyperactivity and sleep bruxism.9
Methods: Fifty-eight patients with chronic TMD were randomly Patients with TMD show muscular hyperactivity,10 and the
assigned to receive either 8 weekly sessions of BFB-CBT or 8 weeks
of OS treatment. Diagnoses were established using Research
reduction of oral parafunctions leads to symptom improve-
Diagnostic Criteria for TMD. Pain intensity and disability were ments.7,9 Nocturnal training with portable electromyography
defined as primary outcomes. Secondary outcomes included emo- (EMG) alarm systems successfully reduces sleep bruxism,
tional functioning, pain coping, somatoform symptoms, treatment which might also improve TMD symptoms.11
satisfaction, and adverse events. NMMA was assessed during 3 Despite the success of CBT, dental treatment with
nights pretreatment and posttreatment with portable devices. Fol- occlusal splint (OS) remains far more common in the clinical
low-up assessment took place 6 months after the treatment. management of TMD.12,13 A recent meta-analysis has con-
Results: Both treatments resulted in significant reductions in pain firmed a modest effect in reducing TMD pain compared with
intensity and disability, with similar amounts of clinically mean- nonoccluding appliances and no treatment.14 Rationales for
ingful improvement (45% for BFB-CBT and 48% for OS). Patients OS use include reducing oral parafunctions and load on
receiving BFB-CBT showed significantly larger improvements temporomandibular structures, and modifying occlusal force
in pain coping skills. Satisfaction with treatment and ratings distribution.13,14 Several studies show a decrease in sleep
of improvement were higher for BFB-CBT. Effects were stable over bruxism during OS treatment, whereas others report no
6 months, and tended to be larger in the BFB-CBT group for all change or even an increase.11,15,16
outcomes. No significant changes were observed in NMMA. Few studies have compared psychological approaches
Discussion: The fact that BFB-CBT resulted in larger improve- with dental treatment. In terms of pain reduction, CBT or
ments in pain coping skills, and was well accepted by the patients, biofeedback seem to be equally effective or superior com-
underlines the importance and feasibility of psychological treat- pared with OS appliances or medical treatment.17–19 In
ments in the clinical management of TMD. clinical practice, patients with TMD mostly seek dental
treatment in the first place, and are referred to other spe-
Key Words: temporomandibular disorders, randomized controlled
cialists with symptoms being heterogenic. Psychological
trial, biofeedback, cognitive-behavioral treatment, occlusal splint
distress often remains unaddressed that might contribute
(Clin J Pain 2013;29:1057–1065) to chronic development of the condition.20 Therefore, the
comparison of dental and psychological treatment is highly
relevant. However, former studies have a number of impor-
T emporomandibular disorders (TMD) are characterized
by pain or dysfunction in the temporomandibular mus-
cles and joint, limited mandibular motion, and joint sounds.1
tant shortcomings. The majority of studies have assessed
treatment success solely in terms of pain reduction. However,
following recommendations of the Initiative on Methods,
Measurement, and Pain Assessment in Clinical Trials
Received for publication April 22, 2012; revised December 22, 2012; (IMMPACT),21 other important outcomes such as activity
accepted December 27, 2012. interference, emotional functioning, pain coping, treatment
From the Departments of *Clinical Psychology and Psychotherapy; satisfaction, and possible adverse effects should be considered.
wProsthetic Dentistry; and zOral and Maxillofacial Surgery,
Philipps University of Marburg, Marburg, Germany.
Moreover, the lack of standardized diagnostic criteria, such as
The authors declare no conflict of interest. the Research Diagnostic Criteria for TMD (RDC/TMD)22
A.N. and W.R. contributed equally. constitutes a major shortcoming of former studies.17,19
Reprints: Meike C. Shedden Mora, PhD, Department of Clinical The aim of the present study was to evaluate a short
Psychology and Psychotherapy, Philipps University of Marburg,
Gutenbergstr. 18, 35032 Marburg, Germany (e-mail: m.shedden@
biofeedback-based cognitive-behavioral treatment (BFB-
staff.uni-marburg.de). CBT) compared with dental treatment with OS. First, it
Copyright r 2013 by Lippincott Williams & Wilkins was hypothesized that (1) improvements in pain intensity

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Shedden Mora et al Clin J Pain  Volume 29, Number 12, December 2013

and functional limitations would occur in both treatment purposes, however, in the context of this randomized con-
conditions, but (2) BFB-CBT would be more effective in trolled trial it was important to apply dimensional outcome
improving secondary outcomes such as emotional func- measures sensitive to change.25,26 NMMA was recorded at
tioning, pain coping, and somatization. Second, we aimed home during 3 consecutive nights (see below).
to investigate whether reductions in nocturnal masseter Patients were reassessed after completing treatment.
muscle activity (NMMA) occurred during treatment, and They were asked to complete questionnaires, to record
whether clinical improvements are also reflected in reduced NMMA, and underwent examination according to RDC/
nocturnal masseter muscle activity. TMD by another trained and calibrated dentist/maxillofacial
surgeon blind to subject status. Follow-up assessment took
MATERIALS AND METHODS place 6 months after the end of treatment. Patients were
asked to complete questionnaires and to return them by
Participants mail.
Patients seeking treatment for chronic TMD at the
Marburg Dental School, Philipps University of Marburg,
Germany were recruited for this study by the Department Primary Outcomes: Pain and Disability
of Prosthetic Dentistry and the Department of Oral and Characteristic pain intensity was calculated by aver-
Maxillofacial Surgery. In addition, dental clinics in Mar- aging ratings of current pain, average pain, and worst pain
burg were informed about the study and referred eligible in the past month on a numeric rating scale from 0 to 10, as
patients to the Department of Prosthetic Dentistry. Patient recommended by RDC/TMD.22 Following IMMPACT
recruitment and follow-up assessment took place from recommendations we compared the 2 groups in terms of
August 2008 to April 2011. clinically meaningful improvement, defined as reduction in
Study inclusion criteria were as follows: (1) a painful characteristic pain intensity of at least 30% from baseline to
axis I TMD diagnosis according to the Research Diagnostic posttreatment (responder). An increase of pain intensity of
Criteria for Temporomandibular Disorders (RDC/TMD),22 at least 30% was defined as an aggravation of pain.27
in other words group I (myofascial pain), or group III Pain-related disability was assessed using the Pain
(arthralgia, arthritis, arthrosis) or both; patients could also Disability Index (PDI).28 The PDI is a brief self-rating scale
have a group II diagnosis (disk displacement), but a painless that assesses the level of pain-related disability in 7 areas of
group II diagnosis was not sufficient for study inclusion; (2) daily life (eg, social activity, self-care) on a 0 to 10 numeric
pain present for at least 3 months; (3) age between 18 and 70. rating scale. The Cronbach a was 0.87 in the current
Patients were excluded for any of the following: (1) sample.
presence of an OS already matching to our standards, for Jaw use limitations were measured using the Jaw Dis-
example an OS as described below (patients could be ability List (JDL) from the RDC/TMD. The JDL asks the
included if they currently used a splint that did not meet our patient to rate interference with 11 oral activities, for
standards, such as a non-OS); (2) need for further diagnostic example chewing or talking. We used an 11-point numeric
investigation or need for dental/maxillofacial treatment, as rating scale instead of ratings of “yes” and “no”. The
judged by a specialized dentist; (3) other major chronic pain Cronbach a was 0.86 in the current sample.
conditions predominant in disability, for example chronic
low back pain or headache, as assessed in the diagnostic Secondary Outcomes
interview; (4) major medical or psychiatric conditions that
would interfere with the ability to participate. Emotional Functioning
The flow of patients through the study is shown Depressive symptoms were measured using the Centre
in Figure 1. A total of 103 patients reported interest in for Epidemiological Studies Depression scale (CES-D).29
study participation. Thirty-three patients were not eligible The CES-D asks for the frequency of 20 symptoms of
for study participation. Twelve patients refused to partic- depression during the past week on a scale ranging from 0
ipate. The main reasons for declining participation were the (less than 1 d) to 3 (5 to 7 d). It is suitable for use in chronic
unwillingness to be randomized, time commitment for pain patients as it relies less on physical symptoms of
treatment, and distance to the clinic. Finally 58 patients depression than do other measures. The Cronbach a level in
were enrolled in the study (Fig. 1). the current sample was 0.89.
General anxiety symptoms were assessed using the
Procedure 7-item scale from the Patient Health Questionnaire (GAD-
The study was approved by the ethics committee for 7).30 The GAD-7 asks for anxiety symptoms during the past
medical research at the University of Marburg. The trial month on a 1 (not at all) to 2 (more than half of the days)
was registered at Clinical Trials (http://www.clinicaltrials. rating scale. The Cronbach a level in the current sample
gov; trial code NCT00769561). We followed CONSORT was 0.64.
guidelines for reporting randomized trials.23
Patients were informed about the study and gave their
written informed consent. RDC/TMD axis I diagnoses Pain Coping
were established by 2 dentists who were trained and cali- Cognitive and behavioral pain coping strategies were
brated in RDC/TMD diagnostic process. The presence of assessed with Coping Strategies Scale from the German
psychiatric disorders was verified by a trained clinical psy- Pain Coping Questionnaire (FESV).31 The scale asks for the
chologist with structured clinical interview for DSM-IV.24 use of 24 cognitive (eg, cognitive restructuring) and
Patients were asked to complete questionnaires. Some of behavioral (eg, use of relaxation techniques) strategies for
the outcome measures chosen for this study differed from coping with pain on a scale ranging from 1 to 6. A sum
the original RDC/TMD axis II recommendations (see score was used with higher scores indicating more adaptive
below). The proposed measures are more useful for screening coping. The Cronbach a level was 0.80.

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Clin J Pain  Volume 29, Number 12, December 2013 Cognitive-behavioral Treatment for TMD

FIGURE 1. Patient flow (CONSORT diagram).

Somatoform Symptoms and TMD-related Symptoms Satisfaction with treatment was measured on a 13-item
Somatoform complaints during the past week were rating scale adapted from a randomized controlled trial for
assessed using the Screening for Somatoform Symptoms chronic tinnitus.35 A mean score ranging from 0 to 5 was
(SOMS-7).32 Thirty-two medically unexplained symptoms built with higher scores indicating higher treatment sat-
(29 for male patients) representing DSM-IV criteria for isfaction. The Cronbach a level for the scale was 0.90.
somatization disorder were rated on a 0 to 4 scale. A sum Adverse events: Patients were asked with the use of an
score was calculated with higher scores indicating higher open question whether they had experienced any adverse
intensity and burden of somatoform complaints. In the events or aggravation of symptoms.
current sample, the Cronbach a level was 0.88. Demographic and health history measures: Demo-
TMD-related symptoms, such as jaw pain, toothache, graphic variables, general health state (on a scale from 1
or dizziness, were measured using a 41-item TMD symptom “excellent” to 5 “very poor”), the number of treatments
list.33 Following the SOMS-7 scale, intensity of symptoms received for TMD, the number of healthcare providers
experienced during the past week was rated from 0 (not at consulted for TMD during the past 6 months, and medi-
all) to 4 (very high intensity). A sum score was built with cation intake were assessed.
higher scores indicating higher intensity of TMD-related
symptoms. The TMD symptom list has not been evaluated Assessment of NMMA
previously; however, large bivariate correlations with NMMA was recorded during 3 consecutive nights with
somatization (Pearson r = 0.79), medium to large correla- single-channel EMG ambulatory recording devices (Loguva
tions with pain intensity (r = 0.48), and medium correla- Brux, Haynl Elektronik GmbH, Schönebeck, Germany). A
tions with depression (r = 0.37) and anxiety (r = 0.27) detailed description of data assessment and analyses has
provide evidence of good convergent and divergent validity. been published elsewhere.36 Participants were precisely
The Cronbach a level in the current sample was excellent instructed to use the devices. They were asked to note time
(a = 0.93). periods of wakefulness or any problems in a protocol and to
contact the study investigator in case of difficulties.
Additional Measures The analyses of NMMA were performed using a cus-
Participant ratings of global improvement were meas- tom program (LabVIEW 9.0, National Instruments Cor-
ured with the Patient Global Impression of Change scale poration, Austin, TX). Mean number and duration of
(PGIC).34 The PGIC is a single-item rating of improvement bursts per hour sleep were calculated as indicators of
with treatment on a 7-point scale ranging from “very much masseter muscle activity for each nocturnal recording.
improved” to “very much worse” with “no change” at the A burst was defined as a supra-threshold EMG signal
mid-point. (above 10 mV) of 0.25- to 2.0-second duration according

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Shedden Mora et al Clin J Pain  Volume 29, Number 12, December 2013

to Lavigne et al.37 NMMA variables were normalized with weeks. Patients were asked to practice in stressful situations
a logarithmic transformation. The stability of EMG record- associated with increased jaw muscle tension. The device
ings between the 3 nights was good (Pearson correlation was programmed to emit an alarm tone when EMG levels
r = 0.68 to 0.83). exceeded a preset threshold. For nocturnal training, they
were asked to use the home trainer every night for 2 weeks.
Treatment Protocol At night, individual threshold was established as 20% of
After baseline assessment, patients were randomly a strong biting force, and the device emitted an alarm tone
assigned to receive BFB-CBT or OS treatment. Random if EMG levels exceeded the threshold for more than
assignment to conditions was generated by a researcher not 4-second duration. Patients were asked to fill in systematic
involved in the study with the use of randomization soft- reports of their training. Session 5 aimed to improve
ware (GraphPad Software Inc., La Jolla, CA), and assign- relaxation skills by teaching biofeedback-based progressive
ment was concealed in closed envelopes. The treatment muscle relaxation. Furthermore, the BFB-CBT protocol
duration was approximately 8 weeks for both conditions. focused on training patients in pain management using
problem solving skills training (Session 6), thought chal-
BFB-CBT lenging (Session 7), as well as relapse prevention (Session 8).
The BFB-CBT consisted of 8 weekly sessions with 50-
minute duration. Each session contained complementary Dental Treatment With OS
cognitive-behavioral and biofeedback elements, with com- Flat plane acrylic OS were individually fabricated for
parable time and emphasis on both elements. Treatment each patient. Their proposed therapeutic action consisted
was provided by 1 of 3 trained Master’s level psychologists of eliminating centric or eccentric premature contacts,
who had at least 1 year of clinical experience in biofeedback restoring missing posterior support and, when indicated to
and CBT for chronic pain conditions. Therapists received a reduce abrasion, guiding the mandible into a more vertical
thorough training by the first author of this article. Treat- movement pattern. The treatment comprised 5 sessions
ment fidelity was controlled through regular supervision of approximately 20 to 40 minutes. First, maxillary and
sessions (every 2 to 4 sessions), provided by a specialized mandibular dental impressions (session 1) as well as an
clinical psychologist with more than 15-year experience in arbitrary face bow registration (session 2) were taken. Stone
biofeedback and CBT for chronic pain conditions including casts were mounted on a semiadjustable articulator in
TMD. A treatment manual was provided to the therapist therapeutic position after appropriate occlusal registration.
that contained detailed instructions on the treatment Fabricated to fit either the maxilla or the mandible, the OS
rationale, materials to use, and assignment of exercises (the covered all anterior and posterior teeth with 1.5 mm
manual in German language can be requested from the thickness between posterior teeth, and provided simulta-
authors). Session content was largely the same for all neous uniform contacts in the premolar and molar region.
patients, but exact specification depended on patients’ Anterior teeth were in light point contact or were discluded
individual needs, their own causal model, and level of slightly; a slight anterior and canine rise was achieved in
knowledge. Patients received a booklet with the informa- excursive or protrusive functions. After fabrication and ad-
tion discussed in the session, home assignments, as well as a justment (Session 3), all patients were instructed to use the
relaxation audio CD and a video with jaw exercises. splint every night over a period of 8 weeks. In case of
The biofeedback device used during the sessions was present diurnal parafunctional activities patients were also
a 10-channel FlexComp Infinity (Thought Technology, asked to wear the splint during daytime, which was the case
Montreal, QC, Canada). Activity in masseter, temporalis, in 10 patients. If muscular etiology was predominant, which
frontalis, and trapezius muscles was assessed by surface was the case for most patients, they were given instructions
EMG biofeedback, as these sites are involved in oral par- to avoid contact with the splint and tooth contact during
afunctions and TMD pain.9 Feedback of skin conductance daytime. All patients were instructed to return to the clinic
level, finger temperature and breathing activity was used as for reexamination and possible adjustment of the splint
indicators of autonomic arousal. after 1 week (Session 4) and 5 weeks (Session 5). They were
The main aim of the BFB-CBT was to reduce pain and treated by 2 dentists specialized in functional dental treat-
to improve pain-related disability. Biofeedback elements ment. Adherence to splint use was assessed after treatment.
targeted to reduce oral parafunctions by improving pro-
prioceptive awareness, to reduce jaw muscle tension in Statistical Analyses
specific muscle sites, to reduce NMMA, and to improve All statistical analyses were performed using SPSS
general relaxation skills. Cognitive-behavioral elements Statistics 19.0.0 for Windows. Multiple imputation using
aimed to improve pain coping skills and feelings of control. NORM (version 2.03) was used to replace single missing
The intervention was based on treatment protocols for values of questionnaire data with imputed values for
TMD pain that have shown effectiveness in previous stud- existing time points. For missing time points, an intent-to-
ies.4,19 In the first 2 sessions, patients were educated about treat approach with the last value carried forward was used
symptoms and causes of their TMD, and a personal that included all randomized patients with available base-
etiological model was established. The importance of psy- line data starting treatment.
chophysiological relations was demonstrated with a stress- As recommended by IMMPACT, characteristic pain
relaxation-test using biofeedback. In the third session, a intensity and disability were defined as primary outcomes.
habit reversal technique was used to increase awareness of Secondary outcomes included depression, anxiety, pain cop-
tooth contacting habits and to implement a relaxed jaw ing, somatoform symptoms, and TMD-related symptoms.
posture.38 In the fourth session, patients received an EMG To determine general efficacy and differences between
biofeedback home trainer (Loguva Brux) for diurnal and groups on primary and secondary outcomes, 2 repeated-
nocturnal biofeedback training.7,11 Diurnal biofeedback measures multivariate analyses of variance (MANOVAs)
training consisted in daily exercises over a period of 2 were calculated, with treatment condition (BFB-CBT and

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Clin J Pain  Volume 29, Number 12, December 2013 Cognitive-behavioral Treatment for TMD

OS) and time (pre, post, follow-up) as factors. In case

of a significant main effect, repeated-measures analyses of TABLE 1. Sample Characteristics
variance (ANOVAs) were calculated for each of the 8 Treatment Condition
outcome variables, correcting for multiple comparisons BFB-CBT OS
using Bonferroni-Holm procedure. In ANOVA, planned Characteristics (n = 29) (n = 27) Statistics
contrasts (pre vs. post, post vs. follow-up) were calculated
to determine when changes took place. Effect sizes and Age ( ± SD) 36.3 ( ± 13.4) 34.3 ( ± 12.5) T = 0.54,
confidence intervals were computed for both groups for P = 0.59
Female gender 86.2% 70.4% w2 = 2.08,
changes from pretreatment to posttreatment and from P = 0.15
pretreatment to follow-up, using the formula by McGaw Education at least 13 y 62.1% 44.4% w2 = 1.75,
and Glass.39 P = 0.19
The ratio of patients clinically meaningful improved Marital status 79.3% 77.8% w2 = 0.02,
was compared between groups using w2 test. Participants’ married/with partner P = 0.89
ratings of global improvement with the PGIC were split up General Health State 3.1 ( ± 1.0) 3.5 ( ± 0.8) T = 1.74,
into those who reported at least some improvement (cor- (1 “excellent” to 5 P = 0.09
responds to rating of 5 to 7), no change (rating of 4), and “very poor”) ( ± SD)
feeling worse (rating of 1 to 3). Ratios were compared with Diagnosis of psychiatric 41.4% 37.0% w2 = 0.11,
disorder (DSM-IV) P = 0.74
w2 test. Treatment satisfaction was compared using t tests. Pain duration in 41.9 ( ± 55.6) 40.3 ( ± 43.1) T = 1.1,
months ( ± SD) P = 0.92
Sample Size Estimation Mean number of 4.1 ( ± 2.6) 2.6 ( ± 2.2) T = 2.32,
Required sample size was estimated using G*Power treatments received P = 0.024
(version 3.0.10) for MANOVA. To detect a minimum effect for TMD ( ± SD)
of f = 0.25 for global treatment effects for primary out- Number of healthcare 6.4 ( ± 6.4) 3.2 ( ± 3.6) T = 2.12,
comes with conventional a and power levels (a = 0.05 and providers consulted P = 0.039
b = 0.80, respectively), a minimum total sample size of 48 during past 6 mo
was required. Considering discontinuation and dropout, ( ± SD)
our aim was to recruit a sample of at least 60 participants. Number of patients taking medication (%)
NSAIDs 7 (24.1%) 7 (25.9%) w2 = 0.06,
P = 0.81
Nonopioid analgesics 5 (17.2%) 3 (11.1%) w2 = 0.36,
RESULTS P = 0.55
Antidepressant 3 (10.3%) 3 (11.5%) w2 = 0.02,
Sample Characteristics medication P = 0.89
Characteristics of the study sample are shown in
BFB-CBT indicates biofeedback-based cognitive-behavioral treatment;
Table 1. Participants were predominantly characterized by OS, occlusal splint.
long illness duration and high levels of healthcare utilization.
The groups were comparable on all sociodemographic vari-
ables except that patients in the BFB-CBT group had
received more treatments for their condition (T = 2.32, and jaw use limitations (F2,53 = 7.13, P < 0.01, partial
P < 0.05) and had consulted more healthcare professionals in Z2 = 0.12). Repeated-measures contrasts showed that all
the past 6 months (T = 2.12, P < 0.05; data only available significant changes occurred from pretreatment to post-
for 50 patients). No baseline differences in primary and sec- treatment and remained stable to follow-up.
ondary outcome variables were found. A distribution of For secondary outcomes, repeated-measures MAN-
RDC/TMD diagnoses is shown in Table 2, with the majority OVA was calculated with TMD-related symptoms, soma-
of patients diagnosed with myofascial pain. toform symptoms, depressive symptoms, anxiety, and pain
coping. Using Pillai’s trace, there was a significant time
General Efficacy and Maintenance of Results effect (Pillai’s trace V = 0.34, F10,45 = 2.22, P < 0.05, par-
Table 3 displays mean, SDs, effect sizes, and confidence tial Z2 = 0.34), but no significant effect for treatment con-
intervals for primary and secondary outcome measures. dition (V = 0.16; F5,50 = 1.85, P = 0.12, partial Z2 = 0.21).
Repeated-measures MANOVAs were calculated with the The condition-time interaction failed to reach level of sig-
number of received treatments as covariate. As information nificance (V = 0.30; F10,45 = 1.87, P = 0.08, partial Z2 =
on healthcare use was only available for 50 patients, it was 0.30). Subsequent repeated-measures ANOVAs revealed
not included as a covariate. For the primary outcomes pain significant improvements in both groups for all secondary
intensity, pain-related disability and jaw use limitations, outcomes: TMD-related symptoms (F2,53 = 18.71, P < 0.001,
repeated-measures MANOVA showed a significant time partial Z2 = 0.26), somatoform symptoms (F2,53 = 4.96,
effect (Pillai’s trace V = 0.30, F6,49 = 3.43, P < 0.01, partial P < 0.01, partial Z2 = 0.08), depressive symptoms (F2,53 =
Z2 = 0.30), but no significant effect for treatment condition 4.43, P < 0.05, partial Z2 = 0.08), anxiety (F2,53 = 14.96,
(Pillai’s trace V = 0.03, F3,52 = 0.46, P = 0.71, partial P < 0.001, partial Z2 = 0.22), and pain coping (F2,53 = 16.10,
Z2 = 0.03). The condition-time interaction failed levels of P < 0.001, partial Z2 = 0.23). All significant changes occur-
significance (Pillai’s trace V = 0.20, F6,49 = 2.02, P = 0.08, red from pretreatment to posttreatment and remained stable
partial Z2 = 0.20). Thus, BFB-CBT and OS did not differ to follow-up, as indicated by repeated-measures contrasts.
significantly in the main outcomes. Subsequent repeated- There was a significant condition-time interaction and
measures ANOVAs revealed significant improvements in group effect for pain coping (F2,53 = 6.89, P < 0.01, partial
both groups on the primary outcomes characteristic pain Z2 = 0.11; and F2,53 = 8.41, P < 0.01, partial Z2 = 0.14,
intensity (F2,53 = 19.61, P < 0.001, partial Z2 = 0.27), pain- respectively), indicating that patients in the BFB-CBT group
related disability (F2,53 = 6.56, P < 0.01, partial Z2 = 0.11), reported larger improvements in pain coping skills than

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In terms of clinically meaningful improvement, 13

TABLE 2. TMD Diagnoses According to the Research Diagnostic patients (44.8%) in the BFB-CBT group and 13 patients
Criteria for Temporomandibular Disorders (RDC/TMD)
(48.1%) in the OS group were classified as responders.
Treatment Condition Accordingly, 2 patients (6.9%) in the BFB-CBT group and
BFB-CBT OS 3 (11.1%) patients in the OS group reported an aggravation
(n = 29) (n = 27) Statistics of pain of at least 30%. The rates did not differ significantly
between groups (w2 = 0.49, P = 0.78), suggesting that
Group I patients responded well to both treatments (Table 3).
Ia: myofascial pain 93.1% 81.5% w2 = 2.64,
P = 0.27
Ib: myofascial pain 6.9% 11.1% Ratings of Global Improvement
with limited opening For participants’ ratings of global improvement, more
Group II patients in the BFB-CBT group reported some improve-
Any disk displacement: 31% 37% w2 = 0.25, ment (26 patients [88.9%] in the BFB-CBT group, 16
left P = 0.64 (left) patients [59.3%] in the OS group; w2 = 6.93, P < 0.05).
Any disk displacement: 37.9% 29.6% w2 = 0.43, Two patients (7.4%) in the BFB-CBT group reported no
right P = 0.51 (right)
change, compared with 10 patients (37%) in the OS group.
Group III
IIIa: arthralgia left, 3.4%, 0% 0%, 0% w2 = 4.11, In each group, 1 patient reported a change for the worse.
right P = 0.13 (left)
IIIb: osteoarthritis left, 0%, 0% 0%, 0% w2 = 0.31, Acceptability of Treatments and Adverse Events
right P = 0.58 (right) Satisfaction with treatment was significantly higher in
IIIc: osteoarthrosis left, 3.4%, 6.9% 18.5%, the BFB-CBT group (mean rating 4.0 ± SD = 0.55 vs.
right 11.1% 3.07 ± SD = 0.70 on a scale from 0 to 5) (T = 5.23,
Multiple diagnoses are possible. P < 0.001). Three patients in the BFB-CBT condition
reported an aggravation of symptoms, namely pain in teeth,
jaw pain, and limited jaw motion. In the OS condition,
patients receiving OS. The groups did not differ significantly 7 patients reported change for the worse, namely higher
on the other outcomes. muscle tension, pain in head, back, ears and teeth, jaw
Pretreatment to posttreatment and pretreatment to fol- limitations at chewing, and tinnitus. The ratios did not
low-up effect sizes revealed medium to large effects in differ significantly (w2 = 1.62, P = 0.20).
the BFB-CBT group and small to medium effects in the OS Adherence to splint use in the OS group was assessed
group, according to convention.40 Effect sizes were larger for at the end of treatment, and patients were asked how often
BFB-CBT compared with OS for all outcome variables, they used the splint since the beginning of treatment.
though a significant difference was only found for pain coping Twelve patients reported that they had used the splint every
skills. night, 14 patients reported the use during 3 to 6 nights

TABLE 3. Results of the Randomized Controlled Trial: Primary and Secondary Outcome Measures
Effect Size (g) (ITT) Effect Size (g) (ITT)
Pre-Post Pre-Follow-up
Variables Pretreatment Posttreatment Follow-up (95% CI) (95% CI)
Pain intensity (CPI) (range 0-10)
OS 5.53 (1.97) 3.89 (2.40) 4.21 (2.50) 0.71 (0.29-1.14) 0.48 (0.08-0.88)
BFB-CBT 5.40 (1.94) 3.90 (2.19) 3.62 (2.48) 0.71 (0.30-1.12) 0.78 (0.36-1.19)
Pain disability (PDI) (range 0-70)
OS 13.88 (13.18) 11.62 (12.26) 11.61 (11.91) 0.21 (0.18 to 0.59) 0.16 ( 0.22 to 0.53)
BFB-CBT 17.67 (12.75) 11.07 (12.01) 13.24 (11.96) 0.62 (0.22-1.02) 0.53 (0.14-0.91)
Jaw use limitations (JDL) (range 0-110)
OS 27.04 (21.29) 18.77 (14.47) 18.11 (18.02) 0.46 (0.06-0.86) 0.38 ( 0.01 to 0.77)
BFB-CBT 25.87 (16.23) 18.52 (17.94) 18.39 (16.84) 0.45 (0.07-0.83) 0.40 (0.03-0.78)
TMD-related symptoms (RDC) (range 0-164)
OS 37.44 (17.28) 28.15 (11.46) 28.73 (14.89) 0.65 (0.23-1.07) 0.54 (0.14-0.95)
BFB-CBT 47.69 (24.12) 34.34 (22.53) 35.97 (23.38) 0.75 (0.34-1.16) 0.67 ( 26 to 1.07)
Somatoform symptoms (SOMS) (range 0-128)
OS 11.81 (7.57) 11.30 (9.67) 9.81 (7.91) 0.06 (0.32 to 0.44) 0.28 ( 0.10 to 0.67)
BFB-CBT 14.97 (13.63) 10.64 (10.16) 10.69 (9.67) 0.51 (0.12-0.89) 0.34 ( 0.04 to 0.71)
Depression (ADS-L) (range 0-60)
OS 17.38 (80.05) 16.09 (8.95) 16.67 (10.07) 0.18 (0.20 to 0.56) 0.08 ( 0.30 to 0.46)
BFB-CBT 18.51 (11.72) 13.05 (8.88) 15.05 (11.86) 0.64 (0.24-1.04) 0.70 (0.29-1.10)
Anxiety (GAD-7) (range 7-21)
OS 14.15 (2.35) 13.33 (3.03) 13.04 (2.92) 0.29 (0.09 to 1.04) 0.39 (0.00-0.78)
BFB-CBT 15.15 (2.62) 13.07 (3.44) 12.79 (3.27) 0.86 (0.43-1.29) 0.86 (0.43-1.29)
Pain Coping (FESV) (range 24-144)
OS 59.35 (14.56) 64.69 (20.22) 60.13 (18.90) 0.26 (0.12 to 0.65) 0.07 ( 0.31 to 0.45)
BFB-CBT 62.15 (14.49) 81.80 (19.86) 77.11 (21.04) 1.10 (0.64-1.57) 1.09 (0.63-1.55)
CI indicates confidence interval; ITT, intention-to-treat.

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Clin J Pain  Volume 29, Number 12, December 2013 Cognitive-behavioral Treatment for TMD

a week, and 1 patient used the splint 2 nights or less a week. superior though the difference was not as pronounced as
Of the 10 patients who were instructed to use the splint expected. Effect sizes did not change substantially between
during daytime, 2 patients reported daily splint use, 5 posttreatment to follow-up, showing that improvements
patients used it 1 to 3 nights a week, and 2 patients stated were maintained over the 6-month follow-up period.
that they had used the splint 2 or less days a week. Our findings join a number of previous studies that
In the BFB-CBT group, all patients reported the use of have provided evidence of the general effectiveness of CBT
the portable biofeedback devices during daytime and for for chronic TMD.2–6 In line with the few studies comparing
nocturnal training. Eighteen of 27 patients filled in sys- psychological with dental treatment, we found BFB-CBT
tematic reports about home BFB training, and these reports and OS to be equally effective in terms of pain reduction.
confirmed good adherence (mean number of nocturnal Turk et al19 concluded that OS treatment results in larger
training sessions = 11.1, SD = 5.5; mean number of train- pain reductions on short term, whereas biofeedback and
ing sessions during daytime = 9.6, SD = 3.2). Moreover, stress management lead to larger reductions in pain and
participants in the BFB-CBT group were asked to rate the depression on long term. Similarly, Carlson et al18 showed
usefulness of 4 treatment elements on a 0 (not useful at all) that a behavioral self-regulation training improved pain
to 5 (very useful) rating scale. Ratings were generally slightly more than dental treatment. A recent trial reported
positive, with the highest rating for “therapeutic that a short education program was slightly more effective
conversations” (mean = 4.56, SD = 0.51), followed by than OS treatment.41 Fricton et al14 conclude that
“education about TMD” (mean = 4.33, SD = 0.68), “behavioral therapy has equal efficacy to appliances short
“exercises” (mean = 4.11, SD = 0.70), and “biofeedback” term but may have more positive effects than appliances in
(mean = 3.85, SD = 0.86). the long term, perhaps due to its addressing of the under-
lying central etiologies more effectively than appliances” (p.
Changes in NMMA 249). Given the highly chronic condition and psychological
Forty complete data sets (21 patients in the BFB-CBT comorbidity of our patient sample, both treatment
group and 19 patients in the OS group) were available for approaches can be regarded as successful. The fact that
analysis of pre-post changes in NMMA. The main reasons BFB-CBT resulted in larger improvements in pain coping
for missing data were loosened electrodes during nocturnal skills, but also was well accepted by the patients, underlines
recording, failure to handle the device, or failure to charge the importance and feasibility of psychological treatments
batteries. At baseline, no significant differences were found in the clinical management of TMD.
in NMMA in terms of mean number and mean duration of Contrary to our expectations, no significant changes
EMG bursts (T = 0.77, P = 0.45 and T = 0.61, P = 0.55, occurred in NMMA. Although most patients in our study
respectively). showed clinical signs and reported sleep bruxism, it is
Repeated-measures ANOVAs did not reveal a sig- possible that not all patients with TMD actually exhibited
nificant time or interaction effect for the mean number of elevated levels of NMMA. Previous studies have shown
EMG bursts per hour sleep (F1,38 = 2.57, P = 0.12 and clear relations between self-reported sleep bruxism and
F1,38 = 0.01, P = 0.94, respectively) and the mean duration TMD, but findings on associations of directly assessed
of EMG bursts per hour sleep (F1,38 = 2.61, P = 0.11 and NMMA with TMD pain are inconclusive (for an overview,
F1,38 = 0.00, P = 0.97, respectively). In other words, the see Manfredini and Lobbezoo42). In fact, a recent pub-
amount of NMMA did not change significantly from pre- lication by our group did not show elevated levels of
treatment to posttreatment in either of the groups. NMMA in TMD compared with pain-free controls.36
Longitudinal changes in pain do not show clear relations to
physical changes in jaw function.43 Although both bio-
DISCUSSION feedback and OS may have at least a temporary effect on
The present study aimed to investigate the efficacy of NMMA, physiological changes do not necessarily corre-
BFB-CBT compared with dental treatment with OS for spond to symptom changes. Apart from sleep bruxism,
patients with chronic TMD. The results of general treat- other pathophysiologic mechanisms such as peripheral and
ment efficacy showed statistically and clinically significant central sensitization might contribute to the maintenance of
improvements in characteristic pain intensity, pain-related chronic TMD.15 Moreover, awake oral parafunctions seem
disability, and jaw use limitations, with mostly medium to play a more important role in the development and
effect sizes, for patients in both conditions. In other words, maintenance of TMD pain.9 Thus, increasing awareness
treatments were highly comparable in terms of primary and reducing oral parafunctions may be more important
outcomes. Forty-five percent of the patients receiving BFB- than the reduction of sleep bruxism.
CBT and 48% of patients receiving OS treatment showed Several limitations should be considered: first of all,
clinically meaningful improvement, indicating that patients since our aim was to compare psychological with dental
responded well to both treatments. Patients receiving BFB- treatment, we did not include a combined BFB-CBT and
CBT were more satisfied with the treatment, and rated their OS condition, thus we are not able to estimate the benefits
overall improvement higher compared with patients in the of combining the approaches. Second, the BFB-CBT group
OS group. Slightly more adverse events were reported in the received more treatment sessions, thus we cannot rule out
OS group, though the difference was not statistically the possibility that advantages of BFB-CBT could be
significant. attributed to longer treatment duration or higher amount
For secondary outcomes, BFB-CBT resulted in sig- of attention. An attention control group would have been
nificantly larger improvements in cognitive and behavioral helpful to determine specificity of CBT elements as reported
pain coping skills. Although multivariate analyses only by Turner et al.4 Furthermore, the follow-up period of 6
approached significance, short-term and long-term effect months was rather short; with longer follow-up periods
sizes for BFB-CBT were larger for all secondary outcomes. differential treatment effects might have been more pro-
In line with our hypothesis, BFB-CBT tended to be nounced, as shown in previous studies.44 Moreover, with

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Shedden Mora et al Clin J Pain  Volume 29, Number 12, December 2013

regard to length of the questionnaire, we relied on a single cognitive-behavioral interventions targeted to reduce
item to assess adverse events. For OS, undesired events TMD-related symptom burden and disability.
such as tooth pain, occlusal changes or inflammation have
rarely been considered.14 Nocturnal training, on the other
hand, might interfere with sleep quality and change sleep ACKNOWLEDGMENT
stages. Future studies should assess adverse events in a The authors are extremely grateful to Prof. Dr U.
more systematic way. Although we also targeted oral par- Lotzmann and his staff of the Department of Prosthetic
afunctions in our BFB-CBT treatment protocol, we did not Dentistry, Philipps University of Marburg, for supporting this
systematically assess physiological changes during wake study.
state. Future studies should consider methods to assess oral
parafunctions such as experience sampling methods or
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