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EDGE Task Force on Head and Neck Cancer Outcomes: A Systematic Review of Outcome Measures for Temporomandibular-related Dysfunction

Galantino, Mary Lou, PT, MS, PhD, MSCE1; Eden, Melissa M., PT, DPT, OCS2; Spinelli, Bryan A., PT, MS, OCS, CLT-LANA3; Flores, Ann Marie, PT, PhD, CLT4

Rehabilitation Oncology: 2015 - Volume 33 - Issue 2 - p 6–14
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Background: Patients with head and neck cancer (HNC) often experience significant postoperative limitations in temporomandibular joint (TMJ) function, facial pain, reduced nutritional intake, speech impairments, and compromised activities of daily living due to side effects of cancer treatment. Physical therapists treating these individuals must use valid and reliable patientreported outcome measures to quantify change related to physical therapy intervention for the TMJ.

Purpose: As part of the activities of the Oncology Section EDGE Task Force on Head and Neck Cancer Outcomes, we report evidence-based recommendations for patient-reported outcome measures for individuals with HNC-related temporomandibular dysfunction (TMD).

Methods: A systematic literature review of TMD-related patient-reported outcome measures that are clinically feasible and relevant to the HNC patient population was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) model. Recommendations are based on the quality of psychometric properties, clinical utility, and previous use in HNC-related research. Twenty-two outcome measures were selected for review; 4 received a rating of 3, “recommended” for use in the HNC population.

Conclusions: A variety of outcome measures have been reported in the literature for individuals with HNC-related TMD. Four measures, the Graded Chronic Pain Scale, 8 and 20-item Jaw Functional Limitation Scale and TMD Pain Screener, are recommended for clinical use by the researchers on this task force although it is important to note psychometric properties specific to the HNC population are lacking.

Systematic Review Registration Number: PROSPERO CRD42013004898

1Professor of Physical Therapy, School of Health Sciences, Stockton University, Galloway, NJ

2Assistant Professor of Physical Therapy, Mayo Clinic, Phoenix, AZ

3Rhode Island Hospital, Rehabilitation Services, Providence, RI

4Assistant Professor & Director, Center for Cancer Survivorship Studies, Department of Physical Therapy, Movement and Rehabilitation Sciences, Northeastern University, Boston, MA

Address correspondence to: Mary Lou Galantino, PT, MS, PhD, MSCE, School of Health Sciences, Stockton University, 101 Vera King Farris Drive, Galloway, NJ 08025 (MaryLou.Galantino@stockton.edu).

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INTRODUCTION

The incidence of head and neck cancer (HNC) has remained stable over the past decade due to improvements in the medical management of the disease, and a 5-year relative survival rate of 60% to 65%.1,2 Treatment for HNC may include a combination of surgery, radiation, and/or chemotherapy. As of 2012, there were 364,000 HNC survivors in the United States, many of whom are dealing with the long-term sequelae of HNC treatment.1 The location and nature of the medical management of HNC places survivors at risk for experiencing temporomandibular joint (TMJ)-related impairments and disability, which can lead to temporomandibular joint dysfunction (TMD).2-4

Temporomandibular joint dysfunction is defined as “functional disturbances of the masticatory system.”5 Changes in TMJ, occlusion, ligamentous, or soft tissue structures, or the muscles of mastication eventually can result in TMD. The TMJ and masticatory system is complex and requires a comprehensive understanding of the anatomy and physiology of the arthrokinematics, musculoskeletal, and neurological components in order to treat TMD. Trismus, restricted mouth or jaw opening, is a form of TMD that affects 10% to 50% of those with HNC.4,6,7

Radiation therapy for nasopharyngeal, base of tongue, salivary gland, maxillary, or mandibular often affect the TMJ and associated musculature including the pterygoid and the masseter muscles.4,8 Loss of TMJ function and range of motion from radiation therapy appear to be related to fibrotic changes to TMJ soft tissue, including the muscles of mastication.8,9 The HNC postoperative precautions resulting in changes to movement of the TMJ may also compound emotional aspects and guarding of the TMJ causing a vicious cycle of reduced movement, pain, and altered function.8 Trismus in patients with HNC can have serious health implications, including reduced nutrition due to impaired mastication, difficulty speaking, impaired self-image, ineffective oral hygiene, and compromised assessments for cancer surveillance.6,8 In persons who receive radiation to the head and neck, trismus is often observed in conjunction with dysphagia.10

A systematic review published in 2014 highlights the following 12 core domains and symptoms most affected in HNC survivors: swallowing, oral pain, skin changes, dry mouth, dental health, opening mouth/trismus, taste, excess/thick mucus/saliva, shoulder disability/motion, voice/hoarseness, and social and functional domains.11 It has been reported that individuals with HNC have a lower quality of life (QOL) than age-matched controls and in many cases a lower QOL than individuals with other common cancers.12 However, little research has been conducted studying TMD in people with HNC that fall within the scope of physical therapy practice. The few studies related to TMD in HNC have suggested that pain and restricted motion are problems experienced by some HNC survivors.3,13-15

Physical therapy assessment must include outcome measures of physical function, which may include patient-reported outcome measures (PROs). Despite the risk of TMJ impairments and disability in the setting of HNC, physical therapists have very few HNC-specific PROs from which to choose. In fact, a panel of HNC experts were unable to recommend a PRO specific to TMD or trismus in the “outcomes toolbox for head and neck cancer research,” a series of PROs addressing 18 main areas of concern in the HNC population. The authors only offer an objective measurement for trismus—the interincisal distance.16

When selecting an outcome measure in practice, a physical therapist must first consider the ability to interpret the test score in the population of interest. This requires that the psychometric properties of the outcome measure, such as reliability, validity, sensitivity, specificity, and the ability to detect change, are available in a population similar to the one of interest. Clinical utility, the ease of use, and accessibility of needed resources to administer the measure, are also important factors to consider when choosing an outcome measure. The Evaluation Database to Guide Effectiveness (EDGE) initiative by the American Physical Therapy Association (APTA) is currently identifying core sets of recommended tests and measures to be used within certain patient populations and diagnoses.17 The Oncology Section of the APTA has established task forces for breast, prostate, lung, urogynecologic, and head and neck cancers. The purpose of this systematic review is to identify and provide recommendations of clinically feasible and relevant PROs that address pain and function for use in patients with HNC presenting with TMD.

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DATA & METHODS

This systematic review is registered on PROSPERO (CRD42013004898). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) model was utilized for this systematic review (Figure 1, Appendix 1).18 The appendices for this article can be accessed via ePub at www.oncologypt.org

Figure 1.

Figure 1.

Two investigators (MLG and MME) independently completed the literature search in April 2014 using Ovid Medline. PubMed, PEDro, EBSCO Host, PsycInfo, and Cochrane Databases were subsequently explored using similar search strategies and terms (Figure 2). The literature search was limited to human subjects, availability of an abstract for screening, and publication in the English language. Because little research on this subject is available, we did not exclude studies based on publication date or level of evidence. Once duplicates were removed, 1068 total articles remained for review (Figure 1).

Figure 2.

Figure 2.

Article titles and abstracts were reviewed, yielding 38 identified PROs. Of these, 22 were chosen for inclusion in the systematic review (Figure 1). To be included in the review, outcome measures had to be clinically feasible and patient-reported. Patient-reported outcome measures addressing health related QOL were excluded unless they were specifically developed for the HNC population. In addition, questionnaires assessing nonspecific impairment level constructs (ie, visual analog scale) and other joints/regions not specific to the TMJ region (ie, Dental Discomfort Questionnaire, 10-item cervical questionnaire, Sinonasal Assessment Questionnaire) were excluded. Outcomes specific to HNC that did not contain items related to TMJ function (ie, Cancer Problems in Living Scale, FACT H&N) were also excluded.

The 22 outcomes were divided between the two investigators for analysis. Relevant studies and full-text articles for each measure were retrieved to assess the clinical utility, psychometric properties, and relevance of the PROs to the HNC population. Clinical utility was based upon cost, ease of use and scoring, equipment requirements, and availability of normative data. Ease of use, based on responder burden, and ease of scoring were characterized as easy, moderate, or difficult. The primary reviewer completed the Head and Neck Cancer EDGE Task Force Outcome Measure Rating Form (Appendix 2) for each of the assigned measures. Recommendations for each PRO were provided using a rating scale of 1 to 4, where a rating of 1 is not recommended and a rating of 4 is highly recommended (Table 1). The risk of bias at the study level was not considered when completing the Rating Form, however, we attempted to decrease the level of reporting errors through a review by the second investigator. In the case of disagreement between the two investigators, the rating in question would be brought to the entire HNC EDGE Task Force for consensus.

Table 1

Table 1

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RESULTS

After a systematic review of the HNC literature, 22 TMD-related patient-reported outcome measures were identified for inclusion in this review. The HNC EDGE Task Force recommendations for TMD outcome measures can be found in Table 2.

Table 2

Table 2

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“Highly Recommended” TMD Outcomes Measures

Of the 22 measures reviewed, no outcome measures merited the maximum score of 4 and the rating “Highly Recommended.” The investigators were unable to find a PRO specific to TMD, which was previously utilized in the HNC research and demonstrates strong psychometric properties and clinical utility.

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“Recommended” TMD Outcomes Measures

Four outcome measures received a score of 3, “Recommended.” These outcome measures include the 8-item and 20-item Jaw Functional Limitation Scale (JFLS-8, JFLS-20), the TMD Pain Screener, and the Graded Chronic Pain Scale (GCPS). Although no published evidence of the psychometric properties in the HNC population were found, these measures have demonstrated good psychometric properties and clinical utility in other patient populations (Tables 3 and 4).

Table 3

Table 3

Table 4

Table 4

The JFLS-20 is a 20-item measure derived through expert consensus and subsequently validated using Rasch methodologies in a sample of patients with TMD, primary Sjogren syndrome, burning mouth syndrome, skeletal malocclusion, and healthy controls.19 It includes 3 subscales (mastication, vertical jaw mobility, and verbal and emotional expression) and a global scale of functional limitation of the jaw. The 8-item global scale of functional limitation of the jaw is known as the JFLS-8. The JFLS-8 and the JFLS-20 can both be appropriately utilized to measure TMD dysfunction in clinical and research settings.19,20 Both scales require the patient to rank their level of difficulty on an 11-point Likert scale, where zero suggests “no limitation” and a response of 10 suggests “severe limitation.” The recall period is one month. The total score is calculated by summing the individual item scores, with a higher score indicating greater limitation.19 The JFLS-20 score can range from 0-200 and the JFLS-8 score can range from 0-80.

Internal consistency (Cronbach's alpha) for the JLFS-8 is 0.87 and for the JFLS is 0.95.19 Test-retest reliability, assessed through temporal stability and the concordance correlation coefficient, (CCC rho), is 0.81 for the JFLS-8 and 0.87 for the JFLS-20.19 An effect size for the JFLS-8 of 0.41 has been reported.20 When analyzed separately, the 3 subscales of the JFLS-20 each exhibited excellent psychometric properties with respect to modeled variance, item fit, reliability, and internal consistency among the 5 diagnostic groups.19 Construct and discriminant validity have been established through correlations with other measures, established between-group differences in the subscale and global functional limitation scores,19 and test score independence from constructs such as depression, somatization, anxiety, and other clinical findings.20 The JFLS-8 and the JFLS-20 are also highly correlated (0.9675).19 Neither the JFLS-8 nor JFLS-20 has been used in published HNC research.

The TMD pain screener is a 3-item PRO with a recall period of the last 30 days. The first item addresses the frequency of pain (“no pain,” “pain comes and goes,” “pain is always present”). A response of “no pain” yields a score of zero, “pain comes and goes” yields one point, and “pain is always presents” yields two points. The second item addresses pain or stiffness upon awakening, and the third item is a 4-part question assessing a change in pain level for certain functional activities including chewing, opening/moving the jaw, grinding/clenching, and kissing/talking/yawning. Item two and the 4 components of item three have dichotomous response options of “no” and “yes.” A “no” is awarded zero points and a “yes” is awarded one point. Item scores are then summed, with a test score of zero to 7 points possible. A higher score indicates greater limitation. In a population of subjects with pain-related TMD, internal consistency was deemed excellent (Cronbach's α = 0.87), and temporal stability of individual items (κ) ranged from 0.52 to 0.78, indicating fair to excellent agreement. The summary test score exhibited an intraclass correlation coefficient of 0.83. The tool was found to exhibit sensitivity of 99% and a specificity of 97%. The positive likelihood ratio ranged from 19.2 to 44.6, varying according to the comparison control group, whereas the negative likelihood ratio was 0.01 throughout. Both positive and negative likelihood ratio findings exceeded the accepted benchmarks of 10 or more and 0.1 or less for the positive and negative likelihood ratios, respectively. The TMD Pain Screener has not been used in HNC research.21

The GCPS (version 2.0) is an 8-item PRO. In general, symptom recall is for the last 30 days; however, one item has a 24-hour recall and another item has a 6-month recall period. Six of the items are scored on an 11-point Likert scale, with a response of zero indicating no interference or pain and a response of 10 indicating “pain as bad as could be” or “unable to carry on any activities.” Item one requires the patient to report the number of days the patient experienced facial pain in the past 6 months, and item 5 requires the patient to report the number of days facial pain limited performance of usual activities in the past 30 days. Scores are calculated for 3 subscales: the characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain; the disability score, which ranges from 0-100, is calculated as the mean rating for difficulty performing daily, social, and work activities; and the disability points score, which ranges from 0-3, is derived from a combination of ranked categories of number of disability days and disability score. Subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients into 5 hierarchical categories: grades 0 (no pain) to IV (high disabilityseverely limiting).22

The GCPS is a reliable and valid instrument that assesses the constructs of pain intensity and pain-related disability. The measure's psychometric properties were studied in a population of patients with back pain, headache, and TMJ disorders. The internal consistency was measured with Cronbach's α = 0.84 for the pain intensity subscale and Cronbach's α = 0.95 for the pain-related disability subscale. The temporal stability (2-7 days) was high for pain intensity (CCC = 0.91), pain-related disability (CCC = 0.89), and chronic pain grade (weighted kappa = 0.87).22 Among patients with moderate to severe chronic musculoskeletal pain, the GCPS has been shown to be modestly responsive to changes after 12 months of treatment with an efficacious pain intervention, with standardized moderate effect sizes for the intensity and disability sub-scales of 0.41 and 0.43, respectively. Among participants with chronic knee or hip pain, the standardized effect size for the GCPS intensity was 0.32.23 The GCPS has not been used in HNC research.

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“Unable to Recommend at This Time” TMD Outcomes Measures

Sixteen outcome measures received a score of 2 and are not recommended at this time for use by physical therapists treating individuals with TMD in the setting of HNC. A score of 2 is further categorized as 2A if the measure has been used in the HNC literature or 2B if there is no published evidence that the tool has been used in HNC-related research. Six PROs were designated a rating of 2A, including the EORTC QLQ H&N43,24 University of Washington Quality of Life (UW-QOL),25,26 Liverpool Oral Rehabilitation Questionnaire version 3 (LORQ),27 University of California San Francisco (UCSF) Oral Cancer Pain Questionnaire,28 the Gothenburg Trismus Questionnaire (GTQ),29 and the Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales (LENT/SOMA).30

Two HNC-specific QOL measures were included in the review, the EORTC QLQ H&N 43 and the UW-QOL. The EORTC QLQ H&N43 is the most recent revision of the EORTC QLQ-H&N 35. It currently lacks psychometric studies to support its use. More importantly, similar to the UW-QOL, the EORTC QLQ-H&N43 is a measure designed to quantify health-related QOL and therefore provides a test score interpreted as an overall QOL score for many constructs, not a score specific to TMD. As a result, these two HNC-specific QOL measures cannot be recommended solely for quantification of TMD dysfunction.

The LORQ is a 40-item measure developed through expert opinion. It addresses issues related to oral function, oro-facial appearance, social interaction, and dentures/dental prostheses. While the tool is relevant to the HNC population, it lacks strong psychometric properties and easy accessibility to scoring and interpretation. In addition, over half of the questions pertain to oral prosthetics, therefore decreasing its utility for a large portion of the HNC population.27 The UCSF Oral Cancer Pain Questionnaire is an 8-item PRO used to quantify patients' pain levels before and after surgical resection for oral cancer. Items one, 3, and 5 evaluate the intensity, sharpness and throbbing nature of pain when the patient is not engaged in oral function. Items 2, 4, and 6 measure the intensity, sharpness, and throbbing nature of pain during oral function (talking, eating, and drinking).28 Although some of these items are related to TMJ function, this tool is not specific to TMD and has not been validated for patients with TMD. In addition, the measure is not easily accessible to clinicians. The GTQ is the only measure reviewed specifically designed to measure trismus.29 Unfortunately, the tool is not easily accessible and lacks supporting research. The LENT/SOMA scale addresses radiotherapy toxicities in patients with HNC and is therefore not relevant for use by physical therapists.30

Ten PROs reviewed received a 2B rating, including: Subjective Oral Health Status Indicators (SOHSI),31,32 10-item TMJ Pain Questionnaire,33 Mandibular Function Impairment Questionnaire (MFIQ),34 Modified Symptom Severity Index (SSI),35 TMD Checklist,36 TMJ Scale,19 TMD Questionnaire (LDF-TMDQ), which is also known as the Jaw Function Scale,37 the Manchester Orofacial Pain Disability Scale (MOPDS),38 Tampa Scale for Kinesiophobia,39 and the TMD Self-efficacy Scale.40

Although the SOHSI, 10-item TMJ Pain Questionnaire, MFIQ, Modified SSI, and TMD Checklist may appropriately measure the construct of TMD dysfunction, the questionnaires and information on scoring and interpretation are not easily accessible by clinicians and therefore cannot be recommended. The TMJ Scale is, however, accessible to clinicians, but at a financial cost. It is also 97-items in length and therefore not feasible for use in a busy clinical setting.19 Our review also found that the LDF-TMDQ and the MOPDS have been developed in other countries and may lack validity in the United States. Two PROs, Tampa Scale for Kinesiophobia, and TMD Self-Efficacy Scale, may be of benefit for use in a holistic assessment of TMD, however, do not specifically address the construct of TMD and therefore cannot be recommended at this time.

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“Not Recommended” TMD Outcome Measures

Four outcome measures were given the lowest score of 1 and are not recommended secondary to limited to no available research supporting the psychometric properties of the tools across all patient populations. These outcome measures include the Conti Anamnestic Questionnaire,41 the Oral Impacts on Daily Performance,42,43 TMD Disability Index,44 and the TMJ Score Questionnaire.45

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DISCUSSION

The APTA's Oncology Section Head and Neck EDGE Task Force recommends that physical therapists use the GCPS, JFLS-8 or JFLS-20, and/or the TMD Pain Screener to quantify TMD in patients with HNC. These measures merited a score of 3, “recommended,” because they demonstrate good psychometric properties, but have not been tested or utilized in HNC literature. Each of the recommended measures can be found in the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), which is a compilation of clinical and patient-reported measures designed to assess TMD in clinical and research settings.46 The DC/TMD has two components, Axis I and Axis II. Axis I of the DC/TMD includes the TMD Pain Screener, a symptom questionnaire, demographics, and a clinical examination. Axis II includes various PROs addressing constructs related to QOL, anxiety, depression, and TMD, including the JLFS-8, JLFS-20, and GCPS.47

Only 6 of the 22 measures reviewed in this study have been used in the HNC literature, all of which were not recommended at this time due to concerns regarding tool accessibility, clinical utility, test score interpretation specifically for TMD dysfunction, and availability of psychometric data to merit their use. Given the lack of PROs related to TMJ dysfunction designed for the HNC population, physical therapists are left to use TMJ-related outcome measures that have been designed for other patient populations whose needs may be quite different than the particular concerns of a patient with HNC. Additional research is therefore required to determine the psychometric properties of the measures recommended by the HNC EDGE Task Force in the HNC population, and to further study relevant PROs that could not be recommended by the Task Force at this time. For example, the TMD Disability Index is similar in format to the Oswestry Disability Index and Neck Disability Index, both frequently used PROs in the physical therapy profession for back and neck pain, and has been used in physical therapy research.48-51 Despite its use, the TMD Disability Index received a rating of “not recommended” because psychometric properties for the measure have not been reported.

A systematic review of the literature to identify publications utilizing PROs suitable for oral and maxillofacial surgery found there are numerous questionnaires available, however selecting the most appropriate one can be difficult.52 Ojo and colleagues53 explored HNC QOL instruments and determined that crossstudy comparisons have been hampered by the heterogeneity of measures used in research and the fact that reviews of HNC instruments have not been comprehensively studied. Given the volume and heterogeneity of PROs there is no gold standard HNC-specific TMD questionnaire.53

Similar to the Oncology Section's HNC EDGE Task Force's reviews on neck and shoulder PROs and measurement of external lymphedema for HNC survivors, 54,55,58 the obvious limitation in this review, was that very few of the measures reviewed have actually been utilized to evaluate TMJ-related impairment and disability in the HNC patient population. Referral to physical therapy for HNC related-TMD is underutilized.56 In addition, there are a limited number of investigators with expertise in TMJ-related impairments and function conducting research in the HNC population. Prolonged survivorship due to improved medical management of HNC increases the importance of restoring optimal function in order to improve QOL and function.56 Given the rise in HPV-associated HNCs, improvements in early detection, prevention, and medical management strategies, patients with HNC may have unmet physical therapy needs to reduce or prevent TMJ disability.

To our knowledge, this is the first attempt at providing recommendations for TMD-specific PRO utilization by physical therapists treating patients with HNC. Future research should consider the psychometric properties of PROs, including establishment of normative values and responsiveness to change, addressing TMD in the HNC population. Although great strides have been made in the assessment of PROs and QOL in HNC, more work is needed to improve the clinical utility of these measures in order to link research to clinical practice.9,53,57

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CONCLUSION

The HNC EDGE Task Force recommendations provide physical therapists with evidence-based outcomes measure recommendations for use with patients with HNC presenting with TMD. The HNC EDGE Task Force recommends 4 measures that are easy to use in the clinic with good psychometric properties. These measures fulfill Medicare functional outcome reporting requirements and can provide reliable and valid data from which to quantify patient response to physical therapy interventions.

Our review reveals a gap in psychometric research evaluating properties of available TMJ-related PROs applied in the HNC population. The HNC EDGE Task Force reviews include recommendations for other areas that affect HNC patients that fall under the scope of practice for physical therapy such as neck,54 shoulder,55 and lymphedema.58 Further research is needed to evaluate psychometric properties of PROs for use in the HNC patient population. Studies evaluating HNC-specific PROs' responsiveness to change, generation of normative values, and reliability and construct validity in the HNC patient population are needed. The HNC EDGE Task Force recommendations are a first-step to fill the gap in knowledge of useful, relevant, and patient friendly TMJ-related outcome measures for the HNC patient population.

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ACKNOWLEDGMENTS

No funding was available for this project. All Task Force member efforts were on a volunteer basis. We would like to thank Kelsey Watkins, Student Physical Therapist (Class of 2015) from Stockton University, for her research assistance in this manuscript, and Eliane Purchase, Medical Librarian at the Mayo Clinic in Arizona, for her assistance in developing the research search strategy.

Please note: The appendices for this article can be viewed online at: http://www.ocnologypt.org/publications/rehabilitation-oncology-journal

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Keywords:

temporomandibular; impairment; outcome measure; head and neck cancer

©2015 (C) Academy of Oncologic Physical Therapy, APTA