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J Am Dent Assoc, Vol 137, No 3, 339-347.
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CLINICAL PRACTICE

JADA Continuing Education

Efficacy of an early intervention for patients with acute temporomandibular disorder–related pain

A one-year outcome study



Robert J. Gatchel, PhD, Anna Wright Stowell, PhD, Lynn Wildenstein, MA, Richard Riggs, DDS and Edward Ellis III, DDS, MS


   ABSTRACT
TOP
 ABSTRACT
SUBJECTS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Background. The authors conducted a randomized clinical trial to evaluate the efficacy of a biopsychosocial intervention for patients who were at high risk (HR) of progressing from acute to chronic temporomandibular disorder (TMD)–related pain.

Methods. The authors classified subjects’ risk using a predictive algorithm and randomized them into an early-intervention (EI) or a nonintervention (NI) group. The EI included cognitive behavioral skills training and biofeedback. The authors assessed pain and psychosocial measures at intake and at a one-year follow-up. Subjects’ self-reported pain levels were measured on an analog scale and as a response to palpation.

Results. At one year, EI-group subjects had significantly lower levels of self-reported pain and depression. At one year, more NI-group subjects than EI-group subjects had utilized health care for jaw-related pain. NI-group subjects were 12.5 times as likely to have a somatoform disorder, more than seven times as likely to have an anxiety disorder, and 2.7 times more likely to have an affective disorder at one year, compared with EI-group subjects.

Conclusions. EI-group subjects had reduced pain levels, improved coping abilities and reduced emotional distress at one year.

Clinical Implications. The TMD-related pain experience is complex and requires early identification with a biopsychosocial EI to achieve maximal, sustainable results.

Key Words: Biopsychosocial; temporomandibular disorder; pain; early intervention

The American Academy of Orofacial Pain estimates that 75 percent of the U.S. population experience temporomandibular disorder (TMD) symptoms during their lifetimes and that 5 to 10 percent of those require professional treatment.1 Although TMD prevalence varies widely among studies, researchers surveying the prevalence literature estimated that, in any given year, 10 percent of women and 6 percent of men have TMD pain, which translates to approximately 20 million adults.2 These researchers also estimated that within a six- to 12-month period more than 5.3 million people in the United States seek treatment for TMD, which can result in a conservative cost estimate of $2 billion for direct costs of treatment alone.2 Although studies measuring indirect costs are lacking, researchers found that 28 percent of patients with TMD reported having a greater number of disabilities and limitations, in addition to being unemployed.3 Extrapolating from these researchers’ figures would bring the total cost of TMD to more than $4 billion per year, assuming that the indirect costs most likely would exceed the direct costs. Clearly, TMD is a common and costly disorder.

Traditional treatments for TMD have included interocclusal appliances, nocturnal alarms, physical therapy, surgery, occlusal calibration (also often termed "occlusal equilibration") and cognitive-behavioral skills training (CBT). Several difficulties (for example, including lack of a consistent method for identifying and diagnosing TMD in a research setting, varying durations of treatment, lack of control groups, lack of objective dependent measures and lack of specification of symptom duration) have prevented significant research on effectiveness of various treatment modalities for TMD. Mishra and colleagues4 reviewed the literature and found CBT becoming the treatment modality of choice owing to overall efficacy and effectiveness.5–7 For example, Dworkin and colleagues8 compared the effects of usual TMD treatment (for example, use of splints and medication, heat and cold packs) with group-administered CBT. The latter intervention proved to be more effective therapeutically at a six-month follow-up. Turk and colleagues9 also demonstrated the greater efficacy of a CBT approach (biofeedback [BFB]). Other studies by these research teams also demonstrated the efficacy of such comprehensive and individually tailored interventions.10–14

Mishra and colleagues4 compared four treatment modalities: BFB, cognitive behavioral skills training, combined BFB/CBT and no treatment. They found that the three treatment groups had significantly reduced pain scores and significantly improved mood scores from pre– to post–12-session treatment. Additionally, among the treatment groups, the BFB group showed the greatest improvement. A particular strength of their study was their reliance on the standardized research diagnostic criteria (RDC) developed by Dworkin and LeResche15 for identification and diagnosis of TMD. The RDC uses a biopsychosocial approach to diagnosis and relies on physical, clinical, cognitive, affective and behavioral factors.

Gardea and colleagues16 built on this research, following up on Mishra and colleagues’ original study with a one-year outcome evaluation. They found that all treatment groups maintained their therapeutic gains from pretreatment to the one-year follow-up, compared with the no-treatment group. Also notable in their findings was that the largest treatment gains at one year were associated with the BFB/CBT group when compared with the BFB group. They concluded that the BFB group was associated with more significant gains immediately after intervention because treatment was linked more obviously and directly to the patients’ physical pain complaint. This may have increased the patients’ motivation to comply both in session and with home practice. At one year, the gains in the BFB/CBT group may reflect a combination of immediate benefits of BFB treatment in conjunction with long-term benefits that may be realized after a lifestyle change. Such change may develop after CBT, which requires more time to embrace and implement fully. Short-range positive outcomes afforded by the BFB intervention combined with long-range gains provided by the CBT intervention are thought to explain the increased gains in terms of physical and emotional functioning of the combined group at one year.

Mishra and colleagues’4 and Gardea and colleagues’16 studies represent a continuation of the trend of developing a comprehensive, manual-driven treatment approach for TMD that is biopsychosocial. Both studies included patients who had complaints of pain for more than six months—chronic pain by most standards. The major purpose of our randomized clinical trial was to evaluate efficacy of the combined BFB/CBT treatment intervention among patients with acute TMD. In addition, our clinical trial evaluated whether the progression from acute to chronic TMD-related pain can be avoided by using early intervention (EI) with patients who are deemed at risk of developing into chronic pain. Previous research by some of the authors of our study identified a cohort of patients who were at high risk (HR) of progressing to chronic pain.17 Epker and colleagues18 originally developed a statistical algorithm, in which a logistic regression model relying on self-reported pain intensity scale (characteristic pain intensity [CPI] scale as used in the RDC) ratings and the presence or absence of myofascial pain on palpation (as measured by RDC criteria) in patients with acute TMD correctly classified 91 percent of these patients as being at HR or low risk (LR) of developing chronic TMD problems. We hypothesized that subjects in the EI group would have lower levels of pain at the one-year follow-up relative to subjects in the nonintervention (NI) group, as measured by the CPI scale15 and by their risk score. We further hypothesized that subjects in the EI group would demonstrate improved levels of coping at the one-year follow-up. Lastly, we hypothesized that EI would result in reduced levels of depression and anxiety for subjects in the EI group as evidenced by the Beck Depression Inventory-II (BDI-II) and the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM) Diagnosis (SCID)-I, which assesses major clinical disorders such as anxiety disorder and major depressive disorders.


   SUBJECTS AND METHODS
TOP
 ABSTRACT
 SUBJECTS AND METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Subjects. We randomly assigned 101 consecutive subjects with HR acute jaw pain to EI and NI groups. The sample consisted of 81 women and 20 men, with a mean age of 37.76 years (range, 18.00–61.45 years). Dentists and oral surgeons in a major urban metropolitan area referred patients to a TMD clinical research program at a large, university-based medical center. In addition, we distributed fliers at local universities and placed advertisements in newspapers to recruit subjects. We included in our study adults aged 18 to 70 years who had acute jaw or facial pain that had been present for less than six months. We excluded potential subjects if they had a comorbid pain-exacerbating physical condition (such as cancer or fibromyalgia) or a history of jaw pain before the most recent episode. Although earlier studies with subjects who had chronic TMD provided little guidance regarding effect size with acute subjects, we assumed a 25 percent increase in effect size (using a difference on the CPI scale of 20 between the two groups, and an assumed standard deviation of 5). This yielded an estimated sample size of 22 subjects in each group to achieve a power of.90 and an alpha of .05.

Procedure. At intake, two clinical psychology research personnel (a psychologist [A.W.S.] and a master’s level counselor [L.W.]) explained and obtained informed consent from the subjects. Consistent with our previous research,17 they performed a shortened version of the RDC evaluation. Based on the findings of Epker and colleagues,18 they assessed only the presence or absence of myofascial pain. They based the determination of myofascial pain on the administration of Axis I-Group 1a of the RDC examination form, which consists of palpation of 20 muscle sites involved in the diagnosis of myofascial pain and the subjects’ responses to question no. 3 from the RDC history questionnaire ("Have you had pain in the face, jaw, temple, in front of the ear, or in the ear in the last month?"). An oral surgeon who was knowledgeable in the RDC (E.E.) trained and periodically recalibrated the clinical personnel. The clinical personnel also assessed all of the subjects using a variety of instruments, including psychosocial measures (a general information questionnaire, BDI-II,19 the Ways of Coping, [WOC] research edition,20 the SCID-I and SCID-II, which assesses personality disorders such as passive aggressive disorder and dependent disorder21,22 and a pain intensity measure [CPI scale]).15 Each assessment took approximately 2.5 hours. We paid each of the subjects $70 for their participation in the study. Further specific details about the intake protocol can be found in Wright and colleagues.17

We randomly assigned the subjects to one of two groups: EI, which included individual CBT/BFB, (n = 56) or NI (n = 45). One year after the initial intake evaluation, subjects returned for a full follow-up evaluation. Only one member of the research team (L.W.) was available at the time of the follow-up evaluation because of scheduling reasons. She collected the subjects’ psychosocial, pain and physical measures; these measures also had been taken at intake. We paid the subjects $50 for their time. Throughout the study, we contacted subjects in both groups by telephone every three months to maintain continuity of contact. During the entire study, we encouraged all of the subjects, even those in the NI group, to continue treatment as usual with their outside health care providers if needed; we provided no other advice.

Intervention. We based the EI component of out clinical trial on the combined CBT/BFB treatment described in detail by Mishra and colleagues4 and further deemed most efficacious for long-term results by Gardea and colleagues.16 For our study, we shortened the combined 12-session approach, which consisted of 1.5- to two-hour sessions that we described previously, to six one-hour sessions. We administered treatment in a structured fashion using a standardized treatment protocol manual created specifically for our study. We used a modified version of a CBT program23 for depression as our basic CBT protocol. Additionally, we derived other skill components from various pain management programs known to us. The protocol topics included education regarding the mind-body relationship with an emphasis on stress and the body’s reaction to stress, relaxation training in ideal and everyday settings, use of distraction and pleasant activity scheduling as a means of reducing the impact of pain on activities, cognitive restructuring, self-instructional training and the maintenance of skills. We discussed the concept of stress and its relationship to persistent medical and dental difficulties throughout the six sessions so that subjects would understand that the treatment protocol was a general program aimed at stress-related problems.

The BFB portion of the standardized treatment protocol manual followed a format developed by one of the authors (R.J.G.), who specializes in pain, stress management and BFB. Again, this portion of the protocol reflects a shortened version of that described in detail by Gardea and colleagues,16 which was based on other studies.24–26 In the BFB portions of the sessions, we used an electromyogram (EMG) biofeedback unit and a temperature biofeedback unit, as well as newer biofeedback equipment and software that also measured surface EMG and temperature that we obtained during the study. We placed the EMG BFB electrodes over the subjects’ frontales muscles. Both the older and newer biofeedback systems provided the same EMG and temperature feedback.

All of the subjects also received participant workbooks with reading assignments and homework to be completed between sessions. These materials augmented the content of the sessions and served as reinforcers of the information. We documented any missed or extra sessions. Subjects made up missed sessions before the next session in the sequence administered. The clinical psychology research personnel conducted treatment. Both therapists received individual and group training and weekly supervision from a licensed psychologist (A.W.S.), who was a senior member of the research team. We audiotaped all of the treatment sessions and randomly reviewed these audiotapes to ensure fidelity of treatment administration. Within the EI group, 46 of the 56 subjects completed the full six-session treatment plan. Of the total sample of 101 subjects, only three could not be reached for the one-year follow-up. As a result, we used an intent-to-treat statistical method to calculate the projected one-year follow-up results. To manage missing data, we used the last-observation-carried-forward approach in which missing values are replaced with the last previous nonmissing value.27 We found no statistical differences between those subjects who completed the one-year follow-up (n = 98) and those who did not (n = 3).


   RESULTS
TOP
 ABSTRACT
 SUBJECTS AND METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
Demographic characteristics. Table 1Go presents the demographic characteristics of the subjects in the EI and NI groups. We found no significant differences between these groups at intake. In terms of subjects’ seeing health care providers for jaw pain outside of the study during the study period, we found significant differences between the two groups (Mann-Whitney test, U = 931.5, z = –2.36, P = .02) (Table 2Go).


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  		TABLE 1 Subjects’ demographic characteristics (N = 101).

 

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  		TABLE 2 Visits to a health care provider for jaw-related pain, by group.

 
Physical variables. Pain. On the self-reported CPI scale, both groups’ scores improved significantly at the one-year follow-up compared with at intake. When we compared the groups, we found that they scored similarly at intake; however, at the one-year follow-up, the EI group had significantly lower (less pain) CPI scores (t99 = –2.55, P = .01) (Table 3Go). We also found that the NI group was associated with significantly higher (more pain) CPI scores at the one-year follow-up, relative to the EI group, as evidenced by an interaction effect (F1, 99 = 8.17, P = .01).


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  		TABLE 3 Measures at intake and one-year follow-up, by group.

 
When we used Epker and colleagues’18 algorithm to predict risk status, a complex {chi}2 analysis revealed that 83 percent of EI subjects moved from HR status at intake to LR status at the one-year follow-up ({chi}21 [N = 101] = 12.63, P = .00 [odds ratio {OR} = 5.00; 95 percent confidence interval {CI}, 1.99 to 12.56]), with 47 of the 56 EI subjects (84 percent) and 23 of the 45 NI subjects (51 percent) changing to LR status. Subjects in the EI group were five times more likely to be assessed as being at LR when they were re-evaluated at one-year than were subjects in the NI group. This suggests they had improved abilities to manage pain, as reflected by decreased pain levels at the one-year follow-up. As we discussed at length in our study,17 the risk score consists of the CPI score and administration of the Axis I-Group 1a of the RDC examination form that includes the palpation of 20 muscle sites involved in the diagnosis of myofascial pain and the participants’ responses to question no. 3 from the RDC history questionnaire ("Have you had pain in the face, jaw, temple, in front of the ear, or in the ear in the last month?").15

Psychosocial variables. Coping measures: WOC. We used the relative scoring method for the WOC developed by Vitaliano and colleagues28,29 to provide a measure of a subject’s coping style. We assessed five styles that can be categorized as adaptive or maladaptive. The adaptive styles were "problem-focused" and "seeks social support," and the maladaptive styles were "blame self," "wishful thinking" and "avoidance." If a subject had higher scores for the adaptive styles and lower scores for the maladaptive styles, this indicated that a greater proportion of his or her coping effort was adaptive. Within the EI group, subjects made significant improvements on the blame self subscale from intake to the one-year follow-up (t55 = 2.74, P = .01). Thus, the coping style of EI group members at the end of treatment was characterized by fewer coping resources being expended on the maladaptive strategy of blame self (Table 3Go). The NI group showed little change in coping abilities from intake to the one-year follow-up. When we compared the two groups at intake, we found that they were similar; however, at the one-year follow-up, we found that the coping styles of the subjects in the EI group were significantly more adaptive than those of the subjects in the NI group, as reflected by increased use of problem-focused strategies (t99 = 1.98, P = .05).

Mood and personality measures: BDI. A test for normality of the BDI data using both the Shapiro-Wilk and Kolmogorov-Smirnov tests yielded significant evidence for nonnormality of the data (P < .001). Therefore, we used the nonparametric Mann-Whitney test to evaluate differences from intake to the one-year follow-up between the two groups, and we found the differences to be significant (U = 950.5, z = –2.12, P = .03). The median change of the EI group was 3.0 (n = 56), and the median change of the NI group was 0.0 (n = 45). There were no significant absolute differences between the two groups at intake (Table 3Go).

Mood and personality measures: SCID I and SCID II. Analyses of the prevalence of DSM, Fourth Edition (DSM-IV), Axis I psychopathology revealed that at the one-year follow-up, the subjects in the NI group had significantly more overall DSM-IV Axis I disorders than did the subjects in the EI group ({chi}21 [N = 101] = 21.17, P = .00 [OR = 7.32; 95 percent CI, 3.02 to 17.75). Specifically, subjects in the NI group had significantly higher rates of the DSM-IV Axis I diagnoses of generalized anxiety disorder ({chi}21[N = 101] = 10.36, P = .00 [OR = 7.18; 95 percent CI, 1.90 to 27.13]) and pain disorder ({chi}21 [N = 101] = 23.03, P = .00 [OR = 9.00; 95 percent CI, 3.46 to 23.44]) at the one-year follow-up than did the subjects in the EI group. When we assessed primary groups of DSM-IV Axis I diagnoses (that is, affective disorder, anxiety disorder, somatoform disorder, substance abuse disorder), we observed that the groups were similar at intake, but they differed significantly at the one-year follow-up for anxiety disorder ({chi}21 [N = 101] = 10.36, P = .00 [OR = 7.18; 95 percent CI, 1.90 to 27.13]) and somatoform disorder ({chi}21 [N = 101] = 27.55, P = .00 [OR = 12.50; 95 percent CI, 4.44 to 35.22]). The subjects in the EI group had far fewer diagnoses than did the subjects in the NI group (Table 4Go). We also noted a trend toward significance for the affective disorders ({chi}2 [1, N = 101] = 3.36, P = .07 [OR = 2.70; 95 percent CI, 91 to 7.97]). Subjects in both groups were statistically similar at intake for the same diagnoses.


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  		TABLE 4 DSM-IV* Axis I (clinical) primary groupings of diagnoses.

 

   DISCUSSION
TOP
 ABSTRACT
 SUBJECTS AND METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Our clinical trial demonstrates the therapeutic efficacy of an early biopsychosocial intervention for patients with acute TMD who are at risk of developing chronic TMD. Results demonstrated that pain levels dropped significantly after the biopsychosocial intervention, as assessed at the one-year follow-up. Additionally, when we reassessed risk status at the one-year follow-up, we found that subjects who we initially classified as HR and who were in the EI group were five times more likely to be reclassified as LR, compared with HR subjects who were in the NI group. This indicates subjects in the EI group were more likely to be able to manage pain and discomfort in a way that prevented them from being at risk of developing a chronic, costly pain condition. Interestingly, subjects in the NI group made significantly more health care visits to seek treatment for their jaw pain. The types of providers the subjects saw were important. Many subjects visited more costly providers that could, over time, result in greater overall expense, especially if chronicity developed.

In addition to significantly lowered pain levels, the subjects in the EI group demonstrated significantly improved coping abilities compared with the subjects in the NI group. At the one-year follow-up, the EI group’s coping effort included a significant amount of the adaptive problem-focused style and decreased reliance on the maladaptive blame self style, compared with subjects in the NI group. Measures of mood for subjects in the EI group significantly improved at the one-year follow-up. Specifically, subjects in the EI group had a significantly greater change in BDI depression scores than did subjects in the NI group at the one-year follow-up. As further evidence of improved psychosocial functioning, subjects in the EI group demonstrated overall lower levels of DSM-IV Axis I disorders at the one-year follow-up on the SCID, whereas subjects in the NI group appeared to be significantly more disturbed. In fact, subjects in the NI group were more than seven times as likely to have a generalized anxiety disorder, 12.5 times as likely to have a somatoform disorder, and 2.7 times more likely to have an affective disorder, relative to subjects in the EI group at the one-year follow-up.

The success of the biopsychosocial EI was not surprising in light of the fact that CBT has been shown to be effective in pain treatment.30 CBT also appears to be effective irrespective of medical diagnosis.31,32 For example, a double-blind randomized controlled trial of CBT for the treatment of chronic primary insomnia, which often is seen in a variety of medical disorders, has been shown to be efficacious.33

Of course, in any clinical outcome study of this type, one can point out potential limitations. One might argue that an attention-placebo condition should have been included. We decided, however, not to include this condition for a number of reasons. As O’Leary and Borkovec34 pointed out, using a placebo group in many research projects may be "theoretically, methodologically, practically, and ethically unsound." Freedman35 and Levine36 also comprehensively reviewed significant bioethical concerns associated with the use of placebo-control groups, as well as denial-of-treatment issues that violate the Declaration of Helsinki. An additional limitation of our study was that the follow-up contacts were conducted by one counselor who had seen some of the subjects in the EI group at intake, thus allowing for potential interviewer bias. Of course, it is not always possible to keep evaluators completely blind to subjects’ treatment group, even in drug trials in which there may be specific side effects associated with different drugs. In addition, latent knowledge may allow evaluators to intuit the subject’s treatment group.37 We made every attempt to keep our sole evaluator unbiased by using a structured assessment protocol that was audiotaped for fidelity checks. We did not collect any data on the actual incidence of diagnosable TMD after treatment and therefore, cannot state definitively that TMD was prevented. This awaits future studies. Finally, the findings of this study are limited to pain of muscular origin.


   CONCLUSION
TOP
 ABSTRACT
 SUBJECTS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
Our study built on our previous work in which we identified a group of people with acute jaw pain who were at risk of developing chronic pain. We then randomly divided the subjects into EI and NI groups. The six-session EI was aimed at increasing insight and awareness into the mind-body connection via education, self-regulating pain management technique instruction, stress management instruction and communication skills training. At the one-year follow-up, the subjects in the EI group fared far better in terms of pain and overall emotional functioning than did subjects in the NI group. This demonstrates that a collaborative, biopsychosocial approach can result in the most effective and successful long-term outcomes for people with TMD.


   FOOTNOTES
 

Dr. Gatchel is a professor and the chairman, Department of Psychology, College of Science, University of Texas at Arlington, and a clinical professor, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas. Address reprint requests to Dr. Gatchel at Department of Psychology, College of Science, University of Texas at Arlington, 313 Life Science Building, 501 S. Nedderman Drive, Arlington, Texas 76019-0528, e-mail "gatchel{at}uta.edu".


Dr. Stowell is an assistant professor, departments of Psychiatry and Anesthesiology and Pain Management, University of Texas Southwestern Medical Center at Dallas.


Ms. Wildenstein is a research associate, Department of Psychology, College of Science, University of Texas at Arlington.


Dr. Riggs is in private practice, Dallas.


Dr. Ellis is a professor, Division of Oral and Maxillofacial Surgery, University of Texas Southwestern Medical Center at Dallas.


Practical Science is prepared in cooperation with the ADA Council on Scientific Affairs, the Division of Science, and The Journal of the American Dental Association. The mission of Practical Science is to spotlight scientific knowledge about the issues and challenges facing today’s practicing dentists.


This article was supported, in part, by National Institutes of Health grants 2R01 DE10713, 2R01 MH46452 and 1K05 MH071892.


Interested readers may contact Dr. Gatchel for information concerning the standardized treatment protocol manual used in the study.


   REFERENCES
TOP
 ABSTRACT
 SUBJECTS AND METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
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