Journal of Bodywork & Movement Therapies (2013) 17, 302e308
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journal homepage: www.elsevier.com/jbmt
COMPARATIVE STUDY
Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders: A randomized controlled trial Aysenur Besler Tuncer, PT, Ph.D. a,*, Nevin Ergun, PT, Ph.D. a, Abidin Hakan Tuncer, DDS, M.P.H. b, Sevilay Karahan, M.Sc. c a Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey b Department of Developmental Biology, Harvard School of Medicine and Dentistry, Harvard University, Boston, USA c Department of Biostatistics, Faculty of Medicine, Hacettepe University, Ankara, Turkey
Received 1 July 2012; received in revised form 20 September 2012; accepted 1 October 2012
KEYWORDS TMD; Manual therapy; Home physical therapy; Pain; Maximum mouth opening
Summary The purpose of this study was to compare the short-term effectiveness of home physical therapy (HPT) alone with that of manual therapy (MT) in conjunction with home physical therapy (MTeHPT) performed for four weeks in patients with temporomandibular disorders (TMD). Forty subjects (nine males and 31 females; age, 18e72 years) with TMD were randomly divided into two groups: HPT (n Z 20; five males and 15 females; mean age, 34.8 12.4 years) and MTeHPT (n Z 20; four males and 16 females; mean age, 37.0 14.6 years). Pain intensity was evaluated at rest and with stress using a visual analogue scale (VAS). Pain-free maximum mouth opening (MMO) was also evaluated. Mean change score (MCS) in VAS and the smallest detectable difference (SDD) in pain-free MMO were measured over time. The results were analysed by MANOVA to evaluate the effects of treatment over time. At baseline, the groups did not differ from each other with respect to VAS scores and pain-free MMO (p > 0.05). Within each group, VAS with stress decreased (p < 0.001) and pain-free MMO increased (p < 0.001) over time. Between groups, both time*treatment effect and treatment effect were significant for VAS with stress (p < 0.001); however, only time*treatment effect was significant for pain-free MMO (p Z 0.009). In the MTeHPT group, MCS for VAS with stress was 91.3% and SDD for pain-free
* Corresponding author. 1691 Beacon Street, Unit # 2, Brookline, MA 02445 USA. E-mail address:
[email protected] (A.B. Tuncer). 1360-8592/$ - see front matter ª 2012 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jbmt.2012.10.006
Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders
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MMO was 10 mm. Our results suggest that a four-week period of MTeHPT has a clinically significant effect on both pain and pain-free maximum mouth opening in patients with TMD. ª 2012 Elsevier Ltd. All rights reserved.
Introduction Temporomandibular disorder (TMD) is a collective term for structural and functional disorders involving the temporomandibular joint (TMJ) and/or the masticatory muscles, muscles of the head and neck and contiguous tissue components (Okeson, 1996). Biological, anatomical, biomechanical, behavioural, environmental and/or emotional factors affect the masticatory system, contributing to the development of signs and symptoms and/or perpetuation of TMD. Therefore, TMD can be considered a multifactorial disease entity (De Leeuw, 2008). It is mainly characterized by pain and restricted jaw movement, with pain being the most common symptom and the most frequent reason for seeking treatment (Dworkin et al., 1990). In the literature, the treatments available for TMD include pharmacological management, oral appliances, occlusal equilibration, physical therapy, TMJ surgery, biobehavioural treatments and patient education (Wright and Sluka, 2001; Okeson, 2003). Home physical therapy (HPT) for TMD includes self-care treatment, patient education, lifestyle modification and self-awareness about the aggravating factors. Specifically, it involves active jaw movements, stretching exercises and correction of body and head posture. It is relatively simple, incurs little cost compared with other treatments and ensures the active involvement of patients (Michelotti et al., 2005). HPT has also been shown to provide relief of masticatory muscle and joint pain (Hanten et al., 2000; Michelotti et al., 2004). Manual therapy (MT) is an area of specialization that has evolved within the field of physical therapy and is the most commonly used approach for the management of spinal symptoms (Gross et al., 2002; Aure et al., 2003). Manual therapy for TMD includes TMJ mobilization, soft tissue mobilization of painful muscles, active or passive muscle stretching exercises, gentle isometric tension exercises against resistance and guided opening and closing jaw movements (Rocabado and Iglarsh, 1991; Von Piekartz, 2005). These relatively reversible, non-invasive treatments are intended to decrease muscle spasm, alter jaw openingeclosing patterns and improve coordination of the muscles of mastication. Various reports have suggested that MT is a viable and useful approach towards the management of TMD (Carmeli et al., 2001; Nicolakis et al., 2002; Kalamir et al., 2007). A systematic review by Medlicott and Harris (2006) evaluated the literature on the efficacy of physical therapy interventions for TMD patients and specifically reported the value of a combined approach of active exercises, MT and relaxation techniques. This review favoured the use of multifaceted TMD treatments. A second review on the efficacy of physical therapy for TMD patients found that postural training, MT and exercise demonstrated significant benefits. The authors concluded that active, passive and postural
exercises are effective interventions for decreasing the symptoms associated with TMD (McNeely et al., 2006). Although a combination of MT and HPT, including patient education, may have been effective for TMD in the past, no reported studies have compared a MT treatment in conjunction with HPT treatment to HPT treatment alone in TMD patients. Therefore, this study aimed to determine the effectiveness of the treatments on pain intensity and painfree maximum mouth opening in patients with TMD.
Methods This study was approved by the Ethics Committee of Hacettepe University, Faculty of Medicine, Ankara, Turkey. All subjects were provided with an explanation of the study and informed consent was obtained from the study subjects. Subjects with a chief complaint of pain in the TMJ region during mandibular movements participated in this study at Hacettepe University, Faculty of Dentistry. One dentist experienced in TMD diagnosed the subjects according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) (Dworkin and LeResche, 1992). RDC/TMD applies a dual-axis system to diagnose and classify patients with TMD. The first axis is divided into three groups of commonly occurring TMDs as follows: Group 1: Muscle disorders, including myofascial pain (Ia) and myofascial pain with limited mandibular opening (Ib) Group 2: Disc displacement with reduction (IIa) and disc displacement without reduction, with limited mandibular opening (IIb) or without limited mandibular opening (IIc) Group 3: Arthralgia, arthritis and arthrosis of the TMJ (III)
Inclusion criteria 1. Subjects with a diagnosis of myogenous TMD according to categories Ia and Ib of the RDC/TMD (Dworkin and LeResche, 1992) were included. In addition to a diagnosis of myofascial pain, the presence of pain on palpation of at least three of 12 muscular points bilaterally was required; these points were present on the temporalis (anterior, medial and posterior bellies) and masseter muscles (deep belly and inferior and anterior portions of the superficial belly) (Friction and Schulman, 1987). 2. Subjects with a diagnosis of anterior disc displacement with reduction according to category IIa of the RDC/ TMD (Dworkin and LeResche, 1992) were included. Painful clicking, crepitation or pain on opening and loaded closing with reproducibility in at least two of three consecutive trials, elimination of a clicking sound on openingeclosing movements from a protruded jaw position and pain in the TMJ during the compression
304 test (De Wijer et al., 1995; Naeije et al., 2009) were additional inclusion criteria for patients with anterior disc placement with reduction. 3. Subjects with pain that was not related to acute trauma, active inflammation or infection in the masticatory muscles/TMJ for at least three months were included. Forty subjects who met the inclusion criteria were enrolled as study subjects.
Exclusion criteria Subjects were excluded if they exhibited any of the following signs or symptoms: disc displacement without reduction, arthritis or TMJ arthritis according to categories IIb and III of the RDC/TMD (Dworkin and LeResche, 1992); a history of chronic TMJ pain, clinical pathology, or previous surgery related to the masticatory system or cervical spine; a history of TMD treatment within the previous three months; neurological or psychiatric disorders that could interfere with the procedure and intake of any medication that affects the musculoskeletal system. Subjects selected for the study received unique identification numbers to conceal their names and designated groups. Based on a computer-generated randomization list, each subject was allocated to one of the treatment groups. All subjects were informed about the treatments; however, the control treatment was not disclosed. In addition, subjects were instructed not to mention their group and treatment during clinical evaluation. Baseline measurements were obtained before group assignment by a physical therapist experienced in musculoskeletal rehabilitation and TMD and was blinded to the subjects’ groups. After four weeks of treatment, the patients’ final assessments were recorded by the same physical therapist. The physical therapist had no access to baseline data at the time of final assessment; furthermore, she was not involved in recruitment, group assignment or data analysis.
Interventions After baseline assessment, the HPT was explained to all subjects by the same physical therapist who performed the baseline assessments. Group I: home physical therapy (HPT) Group I comprised 20 subjects (five males and 15 females; age range, 20e63 years; mean age, 34.8 12.4 years) who received only the HPT treatment, which involved subject education concerning the presumed aetiology of the pain, ergonomic advice, breathing exercises, relaxation techniques, posture correction exercises and mandibular exercises such as active and repetitive assisted muscle stretching, mouth opening and closing, medial and lateral gliding and resistance exercises (Morrone and Makofsky, 1991; Hanten et al., 2000; Michelotti et al., 2004). Group II: manual therapy in conjunction with home physical therapy (MTeHPT) Group II also comprised 20 subjects (four males and 16 females; age range, 18e72 years; mean age, 37.0 14.6
A.B. Tuncer et al. years) who received MT in conjunction with the HPT treatment being the same as that prescribed to the HPT treatment group. MT included soft tissue mobilization (intra- and extra-oral deep friction massage of painful muscles), TMJ mobilization (caudal and ventro-caudal traction, ventral and mediolateral translation), TMJ stabilization (gentle isometric tension exercises against resistance), coordination exercises (guided opening and closing jaw movements), cervical spine mobilization (traction and translation) and post-isometric relaxation and stretching techniques for the masticatory and neck muscles (Evjenth and Hamberg, 1980; Rocabado and Iglarsh, 1991; Kaltenborn, 2003; Von Piekartz, 2005). MT was administered by another physical therapist who was clinically experienced and trained in TMD and MT and was not involved in subject recruitment, group assignment, data collection or evaluation of the MT treatment. All subjects received MT three times a week during the fourweek treatment period. Each treatment session lasted 30 min and was adapted individually to the needs of each subject. Subjects in both groups were instructed to continue HPT for four weeks even if they were relieved of the pain.
Outcome variables The outcome variables were pain intensity at rest, pain intensity with stress and pain-free maximum mouth opening. Pain intensity Pain intensity at rest was measured first, followed by with stress. Pain at rest was defined as pain intensity without stress and was measured in mandibular resting position where the jaws were in the neutral position without any contact between the mandibular and maxillary teeth and any stress on the mandibular muscles. Pain with stress was considered as pain intensity during chewing. Subjects were asked to chew a stick of chewing gum using both sides of their jaws for 60 s and immediately rate their pain on a visual analog scale (VAS). As the tissues became stressed, a response was elicited that determined the presence of TMJ pain (Michelotti et al., 2004). The VAS, which was used to record pain scores in this study, has been shown to be a reliable and valid instrument for measuring pain intensity (Bijur et al., 2001). VAS scores were recorded at baseline and at the end of four weeks, i.e. after the last treatment session. Subjects were told to place a vertical mark along the line to indicate their current pain status, ranging from ‘no pain at all’ (0) to ‘worst possible pain’ (100). Pain-free maximum mouth opening Pain-free maximum mouth opening (MMO) was measured in millimetres at baseline and after the last intervention at the end of the four-week period. Subjects were instructed to open their mouth as wide as possible without causing pain. The inter-incisal distance, i.e. the distance between the maxillary and mandibular central incisors was measured using a millimetre ruler. Because repeated measurements decrease the standard error of measurements (Kropmans et al., 2000), maximum unassisted mouth opening was
Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders recorded three times, and the largest recorded range was considered as the MMO before and after treatment (Von Piekartz and Ludke, 2011).
Statistical analysis Data analyses were performed using SPSS software (SPSS 15.0, Chicago, IL, USA). Continuous variables were expressed as mean standard deviation or median (interquartile), whereas categorical variables were given as frequencies and percentages. The KolmogoroveSmirnov test was used to check for normal distribution. The independent samples t-test was used to evaluate differences in baseline characteristics, namely age, height and weight between the groups. The ManneWhitney U test was used to compare the duration of the complaint. The Chi e square test was used to compare categorical variables, including sex, diagnosis and affected side. VAS and pain-free MMO were compared over time within each treatment group and between groups with repeated measures MANOVA. The Bonferroni test was used for post hoc analysis. The intra-class correlation coefficient (ICC) was calculated to measure testeretest reliability, and the results were considered excellent when ICC was >75% (Fleiss et al., 2003). For all analyses, 95% confidence intervals were presented for each measurement time-point. A pvalue of <0.05 was considered statistically significant for all analysed data.
Effectiveness of the interventions Mean change scores (MCS) were used to measure the clinically important change in VAS score (Kovacs et al., 2008) and change of minimum 30% was considered a clinically relevant statistical result (Farrar et al., 2001). MCS was calculated by subtracting the final VAS scores from baseline VAS scores to correspond to clinical effectiveness (mean change score/baseline*100) (Kovacs et al., 2008). The smallest detectable difference (SDD) was used to evaluate the clinical relevance of pain-free MMO. The clinician was required to have measured a minimum improvement of 9 mm to indicate clinical success (Kropmans et al., 2000). The formula for SDD was 1,96*O2*standard error of measurement (SEM). SEM was calculated as the square root of the absolute error variance. Effectiveness of the interventions was defined as withingroup and between-group effects on the outcome variables and was assessed as per statistical significance and clinical relevance of the statistical results.
Results Baseline characteristics of the subjects are presented in Table 1. A total of 40 subjects (nine males and 31 females) participated in this study. The HPT group (group I) included five males and 15 females while the MTeHPT group (group II) included four males and 16 females. There were no statistically significant differences between the two groups in age, height, weight, complaint duration, diagnosis, affected side, VAS at rest, VAS with stress and pain-free MMO (p > 0.05) at baseline.
Table 1
305
Baseline characteristics of the study population.
Gender (female/male)a Age (years)b Height (cm)b Weight (kg)b Complaint duration (months)c Diagnosis (ADDwR/MP)a Effected side (left/right/both)a VAS at rest (mm)d VAS with stress (mm)d MMO (mm)d
HPT (n Z 20)
MT-HPT (n Z 20)
p
15/5 34.8 12.4 166.4 7.5 62.6 9.9 14.1 9.7
16/4 37.0 14.6 163.8 7.9 64.1 8.6 13.0 11.8
1.000 0.611 0.291 0.612 0.565
14/6 5/10/5
17/3 9/8/3
0.451 0.389
17.5 21.5 66.5 20.6 39.0 6.1
23.0 23.6 62.5 20.5 38.6 6.7
0.446 0.542 0.865
n: sample size, HPT: home physical therapy, MT-HPT: manual therapy in conjunction with home physical therapy, ADDwR: anterior disc displacement with reduction, MP: myofascial pain, VAS: visual analog score, MMO: pain-free maximum mouth opening. a Chi e square test. b Independent sample t-test. c ManneWhitney U test. d Repeated measures MANOVA.
All subjects completed the four-week intervention with no adverse effects. No subject required drug therapy during the study. The ICC (intra-class correlation coefficient) for VAS and pain-free MMO was highly significant (>90%).
Pain intensity VAS scores, both at rest and with stress, significantly decreased in both groups over time (p < 0.001). Time*treatment effect as well as treatment effect were significant only for VAS with stress in the MTeHPT group (p < 0.001). This indicates that VAS with stress was different between the two groups after treatment. It significantly decreased in the MTeHPT group compared with that in the HPT group. MCS for VAS at rest was 34.6% and 59.2% in the HPT and MTeHPT groups, respectively, whereas that with stress was 35.7% and 91.3%, respectively. The clinical significance of MT in the MTeHPT group was higher compared with HPT alone (Table 2).
Pain-free maximum mouth opening Pain-free MMO significantly increased in both groups over time (p < 0.001). Time*treatment effect was significant between groups (p Z 0.009), with a greater increase in the MTeHPT group than in the HPT group. The SDD in pain-free MMO after the treatment period was 4.4 and 10.0 mm in the HPT and MTeHPT groups, respectively, indicating the clinical effectiveness of treatment in the MTeHPT group (Table 3).
Discussion The purpose of this study was to compare the short-term effectiveness of HPT alone with that of MT in conjunction
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Table 2
Changes of pain intensity of the treatment groups.
Outcome variables
VAS at rest
Treatment groups
Baselinea
HPTe MT-HPTf
17.5 21.5 23.0 23.6
4.5 10.0 0.5 2.2
34.6 59.2
<0.001
0.86
0.15
HPTe MT-HPTf
66.5 20.6 62.5 20.5
43.5 20.8 7.0 12.6
35.7 91.3
<0.001
<0.001
<0.001
After interventiona
MCSb
p valued Time
Treatment
Time*treatment
c
VAS with stressc
a b c d e f
Mean standard deviation. Mean change score in percentage. Visual analog score in millimeters. Repeated measures MANOVA. Home physical therapy. Manual therapy in conjunction with home physical therapy.
with HPT in patients with TMD. The decrease in VAS and improvement in pain-free MMO were significantly higher in the MTeHPT group than in the HPT group, indicating the clinical effectiveness of MT-HPT treatment. Treatment approaches for TMD vary largely according to different opinions based on its main aetiology. TMD can have multiple causative factors, and the precise causes are not clearly understood (Okeson, 1996; De Leeuw, 2008). The signs and symptoms of TMD may be transient and selflimiting over time, and most resolve without serious longterm effects. Therefore, the early administration of aggressive and irreversible treatments such as complex occlusal therapy or surgery should be avoided (Okeson, 2003). A review on the management of TMD by List and Axelsson (2010) found that surgery, occlusal adjustment and electro-physical modalities had no effect in alleviating pain related to TMD. The goals of managing TMD are best achieved by using multidisciplinary approaches aimed at decreased pain and increased muscular coordination and strength (McNeely et al., 2006; De Leeuw, 2008). Exercise and patient education have been shown to be effective in the management of TMD (Michelotti et al., 2004). Recently, Michelotti et al. (2012) stated that a patient education programme was slightly more effective than an occlusal splint in decreasing muscle pain in patients with TMD. In our study, we focused on subject education, posture and mandibular exercises using HPT, which both groups received. Postural exercises have been Table 3 Outcome variable
recommended by several authors for the rehabilitation of the craniomandibular system because there is a known relationship between posture and TMJ function (Komiyama et al., 1999; Wright et al., 2000). As per our study results, both the HPT and MTeHPT groups showed an improvement in VAS and pain-free MMO after four weeks of treatment. Multifactorial models have been presented to explain the effect of MT (Gross et al., 2002; Kalamir et al., 2007; La Touche et al., 2009), which is commonly used to decrease pain and restore mobility (Carmeli et al., 2001; Cuccia et al., 2010; La Touche et al., 2011; Von Piekartz and Ludke, 2011). Passive and active stretching of muscles or range-of-motion exercises are performed to increase mouth opening and restore physiological mandibular movements (Evjenth and Hamberg, 1980; Rocabado and Iglarsh, 1991; Ajimsha, 2011). A post-isometric relaxation technique was found to improve active mouth opening in a study (Blanco et al., 2006), while isometric tension exercises against resistance were performed for strengthening the mandibular muscles in another (Nicolakis et al., 2001, 2002). Considering that pain is one of the main reasons for patients seeking care (Dworkin et al., 1990; Okeson, 1996), pain relief is a commonly used outcome measurement while assessing the effectiveness of interventions for TMD. In our study population, pain was the main symptom. Although VAS at rest and VAS with stress decreased over time in both groups, we found that the decrease was larger and the effect of the four-week intervention was more significant in
Changes of pain-free maximum mouth opening of the treatment groups. Treatment groups
Baselinea
HPTe MT-HPTf
39.0 6.1 38.6 6.7
After interventiona
SDDb
41.4 4.7 44.4 4.4
4.4 10
p valued Time
Treatment
Time*treatment
<0.001
0.44
0.009
MMOc
a b c d e f
Mean standard deviation. Smallest detectable difference in millimeters. Pain-free maximum mouth opening in millimeters. Repeated measures MANOVA. Home physical therapy. Manual therapy in conjunction with home physical therapy.
Effectiveness of manual therapy and home physical therapy in patients with temporomandibular disorders the MTeHPT group. The decrease in VAS at rest and VAS with stress was clinically relevant as it exceeded the MCS in VAS. Farrar et al. (2001) determined a 30% decrease in pain to be a clinically relevant difference in patients with chronic pain. In our study, MCS supported the clinical effectiveness of treatment in both groups. In addition, it may be speculated that MT had positive contributions of nearly 25% and 55% on VAS at rest and VAS with stress, respectively, in the MTeHPT group. With regard to the management of TMD, the restoration of physiological mandibular movement is essential. Painfree MMO has been recommended as an outcome measurement in clinical trials on TMD (Carmeli et al., 2001; Blanco et al., 2006; Cuccia et al., 2010) and has been shown to be a reliable clinical sign (Kropmans et al., 1999). In our study, pain-free MMO significantly increased over time in both groups; however, the effect of treatment over time was significantly greater in terms of an increase in pain-free MMO in the MTeHPT group in comparison with the HPT group. According to Kropmans et al. (2000), 9 mm of SDD is used to determine the clinical effectiveness of an intervention with regard to pain-free MMO in patients with TMD. The increase in pain-free MMO after the treatment period was clinically relevant in the MTeHPT group as it exceeded the recommended SDD score (4.4 and 10.0 mm in the HPT and MTeHPT groups, respectively), supporting the clinical effectiveness of treatment in the MTeHPT group. Our findings are in agreement with those from other studies, indicating the effectiveness of MT with exercise in patients with TMD. Nicolakis et al. (2001) demonstrated an overall decrease in pain and improvement in function after treatment in patients with anterior disc displacement with reduction. The treatment included manual joint distraction, disc/condyle mobilization and posture correction. Carmeli et al. (2001) compared the benefit of repositioning splints and manual mobilization combined with exercise for anterior disc displacement and found mobilization with exercise more effective than splints alone. There are factors in this study that justify the improvements observed in the MTeHPT group. MT may influence pain modulation through neurophysiological effects and may influence mobility through a neuromuscular mechanism (Gross et al., 1996). A treatment session tends to motivate a patient to be more compliant with the exercises. In our study, subjects in the MTeHPT group attended 12 MT sessions by meeting the physical therapist three times per week. These sessions had positive effects on the subjects. First, the physical therapist could assess the signs and symptoms at each phase of the recovery process. Second, proper instruction and interaction by the physical therapist can exert positive psychological effects on the subjects, thus alleviating their symptoms to a certain extent. Last, as stated by Feine and Lund (1997), those groups who received more treatment modalities showed better results than those who received fewer. There are limitations to our study. First, the study design did not allow for an evaluation period longer than four weeks. Second, we did not assess the subjects’ compliance level with the recommended treatments. Third, our TMD subjects had myofascial pain with or without limited opening and/or anterior disc displacement with reduction.
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Future research is necessary for investigating the long-term effects of MTeHPT and HPT alone in homogeneous TMD populations; these studies should include assessment of the subjects’ compliance levels as well.
Conclusion In the short term, manual therapy in conjunction with home physical therapy is more effective than home physical therapy alone for the treatment of TMD, particularly with regard to decreasing pain and increasing pain-free maximum mouth opening.
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