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journal of prosthodontic research 63 (2019) 202–209

Contents lists available at ScienceDirect

Journal of Prosthodontic Research


journal homepage: www.elsevier.com/locate/jpor

Original article

Efficacy of mandibular manipulation technique for


temporomandibular disorders patients with mouth opening
limitation: a randomized controlled trial for comparison with
improved multimodal therapy
Kazuhiro Nagata* , Satol Hori, Ryo Mizuhashi, Tomoko Yokoe, Yojiro Atsumi,
Wataru Nagai, Motoatu Goto
Temporomandibular Disorders and Bruxism Clinic, Niigata Hospital, The Nippon Dental University, Niigata, Japan

A R T I C L E I N F O A B S T R A C T

Article history: Purpose: Manual therapy has been used for the treatment of patients with temporomandibular disorders
Received 28 March 2018 (TMD) with mouth-opening limitations. However, the curative effect of manipulation differs among
Received in revised form 16 November 2018 researchers, and its necessity remains controversial. The purpose of this study was to confirm the efficacy
Accepted 17 November 2018
of manipulation using a randomized controlled trial (RCT).
Available online 15 December 2018
Methods: A total of 61 TMD patients who had mouth-opening limitation (upper and lower middle incisor
distance 35 mm) were selected. They were divided into two treatment groups: conventional treatment
Keywords:
(n = 30) and conventional treatment plus manipulation (n = 31). The conventional treatment included
Temporomandibular joint disorders (TMD)
Exercise
two types of self-exercise: cognitive behavioral therapy for bruxism and education. Mouth-opening
Manipulation limitation, orofacial pain, and temporomandibular joint (TMJ) sounds were recorded from baseline to 18
Cognitive-behavioral therapy (CBT) weeks after baseline. These parameters were statistically compared between the two treatment groups
Randomized controlled trial (RCT) by using analysis of variance (ANOVA) and Scheffe’s test to assess mouth opening distance and pain; TMJ
sounds were compared using Mann–Whitney U test.
Results: No statistical difference was observed between the two treatment groups except for mouth-
opening limitation after treatment at the first visit. Subgroup analyses, stratified according to the
pathological type of TMD, indicated a similar trend.
Conclusions: The efficacy of manipulation seems to be limited, in contrast to our expectations, and
improved execution of therapeutic exercises has a similar effect to that of manipulation during long-term
observation. The advantage of manipulation was observed only during the first treatment session. The
RCT was registered in the University Hospital Medical Information Network in Japan (UMIN-CTR:
000010437).
© 2018 The Authors. Published by Elsevier Ltd on behalf of Japan Prosthodontic Society. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

1. Introduction contrast, some RCTs [11–15] have shown that exercise therapy had
no significant effect for patients with TMD. According to these
Exercise therapy, including manipulation, has been used to results, most systematic reviews concluded that the exercise
improve pain and disability in patients with temporomandibular therapy was promising, but its effect was unclear because the
disorders (TMD). Importantly, multiple papers have been pub- quality of the evidence was limited.
lished from the viewpoint of evidence-based medicine (EBM); On the basis of the results of these studies, we concluded that
several randomized controlled trials (RCTs) [1–10] have suggested exercise therapy for TMD is largely divided into two types:
the validity of exercise therapy, combined with other treatments, therapeutic exercise, which the patient performs as self-care at
and have recommended it as a noninvasive and safe treatment. In home, and manual therapy, which the specialist performs in the
clinic. Potentially, the two types of exercises could be used
depending on the pathological type and disability of TMD
* Corresponding author at: TMD and Bruxism Clinic, Niigata Hospital, The Nippon
(e.g., myogenous or arthrogenous disorders, disc displacement
Dental University, 1-8 Hamaura-cho, Niigata, Niigata, 951-8580, Japan. or normal joint, restricted or not restricted temporomandibular
E-mail address: nagata@ngt.ndu.ac.jp (K. Nagata). joint (TMJ) movement). Moreover, manual therapy involves several

https://doi.org/10.1016/j.jpor.2018.11.010
1883-1958/© 2018 The Authors. Published by Elsevier Ltd on behalf of Japan Prosthodontic Society. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209 203

methods, including mandibular manipulation [16] and cervical Table 1. Subjects of this randomized controlled trial
mobilization [17,18]. However, the selective criteria for these TE + MN (SD) TE (SD) Comparison
exercises have not been clearly determined because an objective
Patients number 31 30
comparison has not been performed. In particular, the use of Mean age 48.2 (21.1) 50.7 (18.3) ns
manual therapy for closed lock cases, which are mainly caused by Mouth-opening distance (mm) 28.32 (4.55) 27.02 (5.48) ns
disc displacement without reduction, is controversial. Some Pain NRS 5.76 (2.26) 5.77 (2.79) ns
Sound NRS 2.32 (2.76) 2.10 (2.67) ns
studies have supported its usage [19,20], whereas others have
not [11,12]. TE + MN, standard therapy, including the self-exercise for temporomandibular
The purpose of this study was to confirm the efficacy and disorder (TMD), plus Jog-manipulation.
TE, standard therapy, including the self-exercise for TMD; ns, not significant in the
necessity of manipulation therapy for TMD patients with mouth-
statistical analysis with Student’s t-test.
opening limitation, by performing an RCT to compare manual
therapy combined with therapeutic exercise (TE + MN) and
therapeutic exercise alone (TE). number table of a computer owned only by the administrator, to
ensure concealment.
2. Materials and methods
2.3. Treatment groups
2.1. Participants
TE + MN patients also underwent jog-type jaw manipulation
Participants were selected from among patients who were (Jog-manipulation) [19] as a manual therapy by the predefined
admitted to our Hospital between May 2014 and June 2017. All dentist in charge of the patient (Fig. 2). Jog-manipulation,
participants had been diagnosed with TMD with the Diagnostic developed at our treatment department, was a combination of
Criteria for Temporomandibular Disorders (DC/TMD) axis I [21,22]. four different types of manipulations; a pivot made of gauze was
They had myalgia or arthralgia or mixed, triggered by jaw opening set on the last molar. The following four steps were executed
or palpation; all exhibited mouth-opening limitation, where the continuously: (1) closing type with fulcrums on both sides.
maximum self-opening distance (with pain) between upper and (2) side-to-side type. (3) opening type. (4) closing type with
lower middle incisors was 35 mm. Therefore, all patients were fulcrums on the impaired side. If an insufficient opening, <40 mm,
clinically diagnosed with “disc displacement without reduction, of the mouth could be obtained, the same process was repeated
with limited opening.” These participants provided written three times. The implementation of this technique was conducted
informed consent for the study. The exclusion criteria were as at the first visit and each subsequent visit of the patients until the
follows: (1) inability to visit our clinic during a specific 2-to-4- restoration of mouth-opening limitation <40 mm.
week period; (2) patients wanted to have a particular treatment All TE + MN and TE patients received standard therapy,
(e.g., drug or occlusal treatment); and (3) any mental or physical including self-exercise, cognitive-behavioral therapy (CBT), and
disorders that might disturb treatment. Sixty-six patients were education for TMD. Following our previous RCT regarding the
included in this study; ultimately, 61 patients (11 men, 50 women, splint therapy, we did not use any type of splints in this study [24].
mean age 49.6  25) were statistically analyzed in the RCT (Table 1 The self-exercise consisted of two types of exercise for the
and Fig. 1). mandibular jaw. One exercise pulled down on a patient’s bilateral
The p-values of normality omnibus test with D’Agostino lower last molars with their secondary fingers, while opening the
analysis at baseline were 0.0596 for mouth-opening limitation, jaw to the greatest possible extent (molar pulldown type) [24] with
0.2507 for pain, and 0.0167 for sound. The p-values of homosce- 10 repetitions, three or five times per day (Fig. 3). The other
dasticity with Bartlett’s test were 0.3176 for mouth-opening exercise comprised simplified myo-functional therapy (S-MFT),
limitation, 0.4009 for pain, and 0.8557 for sound. The test of sound combined with (1) maximum mouth opening, (2) clenching, (3)
did not show normality. Therefore, we selected two way-analysis protrusion of the lip, (4) maximum mouth opening and maximum
of variance (ANOVA) for mouth-opening limitation and pain, and tongue protrusion without use of the patient’s fingers; this
Mann–Whitney U test (with Bonferroni correction) for sound. The approach was advocated by Imai [25] (Fig. 4). Instructions were
sample size of this study was determined by using prior power to execute S-MFT every hour throughout the day. The patients were
analysis with G*Power software [23]. Selected statistical analyses guided to perform two types of self-exercise, to the extent that
of G*Power were F-test and ANOVA—repeated measures, within- weak pain was felt every time. If sufficient recovery of the mouth-
between interaction. The following parameters were used: input opening (<40 mm) had been achieved, patients were prescribed a
effect size f = 0.1, α error = 0.05, power = 0.95, number of groups = 2, reduction of exercise strength.
number of measurements = 11. The total sample size calculated was Furthermore, CBT (e.g., guidance regarding clenching control
112; finally, 112/11 = 10.18. Considering subgroup analysis, 30 during waking hours, as well as coping with pain and stress) and
participants were selected for each group in this study. This study education regarding TMD self-management (i.e., a diet of soft foods,
was conducted under the approval of the Ethical Review Board of avoiding gum chewing, and correcting bad posture) were provided.
our Hospital (ECNG-H-153) and under a petition to the University Nine dentists were selected as the predefined practitioners from
Hospital Medical Information Network in Japan (UMIN-CTR: among our clinic members in this study. Each practitioner had more
000010437). than 3 years of clinical experience with TMD treatment and
underwent standardization training for the treatment in this study.
2.2. Study design
2.4. Subgroup analysis
Participants were randomly assigned to TE + MN (n = 31) or TE
(n = 32) with block randomization to equalize the numbers of TMJ diagnosis via magnetic resonance imaging (MRI) was
participants in the two groups. The study was designed as a performed at the second visit for patients who received approval
single-blind RCT, in which participants in each group received for this examination. These patients were categorized according to
detailed explanations of their individual treatment, but further their diagnostic results: normal TMJ (N), disc-displacement with
information was not provided to them to avoid education bias. reduction (3a), and disc-displacement without reduction (3b).
The assignment of blocks was performed based on the random Disc-displacement included anterior, lateral, or partial
204 K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209

Fig. 1. Flow diagram of the randomized controlled trial and subgroup analysis.
*
These patients’ last temporomandibular disorder values were extrapolated to fill in the post-assessment time points, according to the intention-to-treat concept.

Fig. 2. Jog-type jaw manipulation technique (for right side temporomandibular joint).
(a) A pivot made of gauze was set on the last molar. (b) The pivot closing type. (c) The side-to-side type. (d) The opening type. (e) The one-side pivot type. Each manipulation
was executed for 10–20 s, then performed continuously.

displacement of the disc. Osteo-change of the TMJ was not evaluate treatment efficacy. There were 11 measurement points in
considered in this diagnosis because no direct relationship to the the study: baseline, then after treatment at the first visit and every
mouth-opening limitation was inferred in comparison with the 2 weeks thereafter, from 2 to 18 weeks after baseline. The mouth-
disc displacement. Each pathological group was compared to opening distance between the upper and lower medial incisor was
investigate the influence of the treatment on each pathological measured with a caliper. Participants were instructed to open their
type of TMD. Fourteen participants declined or were not able to mouths as widely as possible, even if they felt pain. Orofacial pain
undergo MRI examination; 23 participants in the TE + MT group (i.e., TMJ or masticatory muscles), as well as TMJ sounds, were
and 24 in the TE group underwent the examination. estimated using a self-reported numerical rating scale (NRS) with
scores ranging from 0 to 10. If a drug therapy or manipulation other
2.5. Evaluation parameters than the pre-arranged protocol was provided to a participant when
an insufficient decrease in TMD signs/symptoms was achieved
Three TMD signs/symptoms of mouth-opening distance, after several treatments, or if a participant canceled treatment
orofacial pain, and TMJ sounds were recorded for all patients to before the completion of this study, the patient’s last values were
K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209 205

Fig. 3. Self-exercise of the jaw for temporomandibular disorder patients.


This conservative exercise was performed three times daily. It promotes smooth condylar transfer by pulling down the rearmost molars.

Fig. 4. Simplified myo-functional therapy (S-MFT).


(1) maximum mouth opening, (2) clenching, (3) protrusion of the lip, (4) maximum mouth opening and maximum tongue protrusion. This developed exercise was performed
several times each day.

extrapolated to fill in the post-assessment time points, in


accordance with the intention-to-treat concept. 3. Results

2.6. Statistical analysis All three parameters significantly improved over time in both
treatment groups (Fig. 5). These improvements continued until the
For each parameter, changes invariables were not observed after 10 sixth measurement point; however, most improvements were
weeks. Therefore, statistical analyses were performed only from observed by the third measurement point, with the exception of
baseline through the 10-week measurement point. A two-factor the TMJ sound. In the overall comparison of the two treatment
repeated-measures ANOVA was used to evaluate the efficacy of the groups, TE + MN tended to be superior to TE with regard to mouth-
two treatment modalities (TE + MN vs. TE); Scheffe’s multiple opening limitation and TMJ sound. However, ANOVA from the
comparison test was used to compare mouth-opening limitation baseline up to the sixth measurement point (10 weeks) and
and pain during each treatment period, Mann–Whitney U test (with Mann–Whitney revealed no statistically significant differences
Bonferroni correction) was used to compare sound during each between treatment groups with respect to changes in the mouth-
treatment period. The same analyses were performed in the subgroup opening limitation. There was no statistically significant
analysis to clarify the pathological specificity of the treatment. Excel interaction between time and treatment group for any of the
add-in software (SSRI Co., Ltd., Tokyo, Japan) was used for all analyses. outcome measurements (P > 0.05).
206 K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209

Fig. 5. Changes in mouth-opening distance (mm), pain score and sound score (NRS), comparing TE + MN and TE.
Data points indicate the mean and 95% confidence interval.
The results of ANOVA and Scheffe’s multiple comparisons of mouth-opening distance and pain and Mann–Whitney U test (with Bonferroni correction) of sound from baseline
through 10 weeks are shown with p-values. No statistical difference was revealed between TE + MN and TE other than after the first treatment in mouth-opening distance.
TE + MN, standard therapy, including the self-exercise for temporomandibular disorder (TMD), plus Jog-manipulation. TE, standard therapy, including the self-exercise for
TMD.

The results of Scheffe’s test showed statistical differences Table 2. Results of magnetic resonance examination of the temporomandibular
between treatment groups after the first treatment in terms of joint at the second visit in each treatment method

mouth-opening limitation; the mean average increment was n 3a 3b


6.86 mm (95% CI = 8.12–5.55). In contrast, no significant differences TE + MN 4 5 14
were observed after the second visit. No complications or side TE 5 6 13
effects were observed in both treatment groups during the
N, normal; 3a, disc-displacement with reduction; 3b, disc-displacement without
evaluation period. reduction.
The results of subgroup analysis regarding MRI examination for There was no statistical difference between the two treatment groups (P = 0.77).
TMJ in each treatment group showed no differences in ratio of the
pathological type by Fisher’s exact test (P = 1.00) (Table 2). The major mechanism of mouth-opening limitation. Hence, it is
incidence ratios of disc recapture in centric occlusion were 9/23 reasonable that recapturing the disc is considered necessary to
(39.1%) in TE + MN and 11/24 (45.8%) in TE before the second visit. improve this type of TMD, and that TMJ manipulation has been
There was no statistical difference between the two treatment used to restore the disc [16].
groups (P = 0.77). However, some case-studies have revealed that even if
In the results of subgroup analysis regarding pathological manipulation was used and mouth-opening limitation improved
differences, ANOVA revealed statistical differences between the in patients with anterior disc displacement without reduction
two treatment groups only in the mouth-opening limitation of (ADDWo/R), the disc recapturing was limited [26,27]. Moreover,
pathological group 3a (Fig. 6-3a). The pain and sound score did not even when the disc is recaptured, a considerable number of cases
differ among all pathological groups (Figs. 7 and 8). The results of will be re-dislocated without symptomatic recurrence [28].
Scheffe’s test showed statistical differences between treatment Because of these observations, negative views have been shared
groups after the treatment at the first visit with regard to mouth- regarding the effectiveness and necessity of manipulation techni-
opening limitation (Fig. 6). Subgroup analysis indicated a trend ques; thus, the efficacy and necessity of the manipulation remain
similar to that of the comprehensive comparison, which combined controversial. For these reasons, we conducted an RCT on TMD
all three pathological types. The characteristic findings, based on patients with mouth-opening limitation; we compared combined
pathological state of TMD, were not clear. standard treatment and manipulation with standard treatment
alone to evaluate the clinical effect of manipulation.
4. Discussion In the current criteria for DC/TMD [21], the diagnosis of TMD is
based on one of the following situations: (1) muscular pain, (2) TMJ
Mouth-opening limitation of TMD arises from multiple pain, (3) disc displacement, and (4) degeneration of TMJ. These
causes, such as masticatory muscle disorder, TMJ disorder, and pathological situations may influence treatment results. However,
central nervous system disorder. Nonetheless, disc displace- manipulation was originally designed for closed lock patients with
ment without reduction of TMJ has been presumed to be a disc displacement without reduction to recapture the disc.
K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209 207

Fig. 6. Changes in mouth-opening distance (mm) of TE + MN and TE in each pathological type.


Data points indicate the mean and 95% confidence interval. The statistical difference between the two treatment groups, by ANOVA, was observed only in the pathological 3a
type. Scheffe’s multiple comparisons showed significant differences only after treatment in every pathological type. TE + MN, standard therapy, including the self-exercise for
temporomandibular disorder (TMD), plus Jog-manipulation. TE, standard therapy, including the self-exercise for TMD.

Fig. 7. Changes in pain score TE + MN and TE in each pathological type.


Data points indicate the mean and 95% confidence interval. No statistical differences were observed between the two treatment groups by ANOVA and Scheffe’s multiple
comparisons. TE + MN, standard therapy, including the self-exercise for temporomandibular disorder (TMD), plus Jog-manipulation. TE, standard therapy, including the self-
exercise for TMD.
208 K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209

Fig. 8. Changes in sound score TE + MN and TE in each pathological type.


Data points indicate the mean and 95% confidence interval. No statistical differences were observed between the two treatment groups by Mann–Whitney U test (with
Bonferroni correction). TE + MN, standard therapy, including the self-exercise for temporomandibular disorder (TMD), plus Jog-manipulation. TE, standard therapy, including
the self-exercise for TMD.

Moreover, our previous RCT revealed that the pain was sufficiently hands were otherwise occupied. We presume that these character-
alleviated in both treatment groups; manipulation did not affect istics are extremely useful in mandibular exercises, and that this is
pain for closed lock patients [19]. Therefore, we considered that the reason that the difference between TE + MN and TE was
there was little need for classifying patients according to pain; we reduced in our present RCT.
evaluated disc displacement only in subgroup analysis. As described above, the effect of the manipulation seems to be
The results of this overall comparison of TE + MN and TE showed limited, compared with our expectations. If so, does manipulation
statistical differences only in the mouth-opening limitation after have no superiority over therapeutic exercise? From our finding,
the treatment at the first visit. This indicates that the effect of the 6.86 mm (95% CI = 8.12–5.55 mm) improvement of mouth opening
manipulation appeared to be limited, in contrast to what we had was observed after the initial implementation of manipulation,
expected prior to this study; moreover, the developed therapeutic without increasing pain. This is considered to be a salutary effect
exercise demonstrated an effect similar to that of manipulation in for patients with mouth-opening limitation. Notably, manipula-
the long term. This conclusion was different from that of our tion had no effect for the pain and the sound, such that the
previous RCT [19], which revealed clinical superiority of manipu- treatment effect was limited to mouth-opening limitation.
lation as analyzed by ANOVA (P = 0.000008). Therefore, we recommend that practitioners implement manipu-
We considered that the inconsistency might be caused by lation only once, at the first visit for patients with mouth-opening
differences in the exercise therapies used in the two RCTs. In the limitation; we also recommend guiding the patients through the
previous study, we used only the molar pulldown type as the relevant therapeutic exercise continually from the first visit, even
therapeutic exercise, whereas in the present study, we combined when patients exhibit acute symptoms.
two types of therapeutic exercises: the pulldown and S-MFT. The difference of the control group was assumed to affect the
Consequently, additional S-MFT may have led to improvement in results of RCT. If no-treatment, education, some splints, or conven-
the symptoms of the TE treatment group. S-MFT combined four tional exercise therapy without S-MFT were only used for the control
types of exercises without the assistance of a patient’s fingers. Each group, the statistical difference may be clarified. However, when a
exercise produced an extension and contraction of the masticatory practitioner selects multimodal therapy combined with improved
muscle, the perioral muscle, the opening muscle, and hyoid bone exercise and habit control, the validity of the RCT using the no-
muscle. As a result of this complex effect, S-MFT is presumed to treatment control or education control will be disturbed. Therefore,
improve the disorder of TMD at an early stage. Notably, the we conclude that our RCT exhibited limited applicability—to practi-
maximum opening, accompanied by protrusion of the tongue, can tioners mainly using rehabilitation therapy. The control group of this
assist the smooth sliding motion of the condylar and enable the study used the improved therapeutic exercise, which was presumed to
stretching movement of digastric or suprahyoid muscles, which is be effective for mouth-opening limitation.
difficult in other exercises. Moreover, S-MFT does not require a In subgroup analysis, the recapturing ratio of the disc in centric
patient’s hand or finger support, as in other exercise therapies occlusion was not statistically different between TE + MN and TE.
including the pulldown type. Thus, patients were able to easily Both recapturing ratios, including normal and ADDW/R, were
apply S-MFT at any place and any time, even at work or when their approximately 40%. In previous reports, the recapturing ratios after
K. Nagata et al. / journal of prosthodontic research 63 (2019) 202–209 209

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