What is the force required to treat trismus in patients undergoing oral cavity free flap reconstruction?

BACKGROUND: Trismus therapy is often delayed after jaw reconstruction to avoid hardware failure or non-union. The aim of this study is to document the forces that have been applied to patients undergoing free flap reconstruction of the oral cavity in the 12 months following oral cavity reconstruction, and to analyze the associations between force and maximal interincisal opening (MIO) over time. METHODS: Participants with trismus after free flap reconstruction of the oral cavity completed a 10-week jaw stretching program using Restorabite™. Primary outcome measures included the minimum and maximal force applied by a trismus device during rehabilitation, MIO, bone union, and health-related quality of life outcomes up to 12 months postoperatively. RESULTS: A mean of 20.6 Newtons (N) was used during passive exercises and 38.9 N during active exercises was used during trismus therapy. The mean increase in MIO for the 45 participants after 10 weeks, 6 months, and 12 months of therapy was 8.4 mm (p < 0.001), 12.6 mm (p < 0.001), 12.7 mm (p < 0.001), respectively. There was no significant difference in the mean minimal (p = 0.37) or mean maximal (p = 0.08) force applied between those who underwent osseous free flap reconstruction compared to fasciocutaneous only, respectively. In patients who underwent osseous reconstruction, 25 (67.6%) had complete bone union and 12 (32.4%) had partial union at 12 months postsurgery. CONCLUSIONS: In participants undergoing osseous free flap reconstruction, there was no association between the force applied to the rates of bone union. Further research to define safe and optimal loading may benefit patients undergoing jaw reconstruction.

Systematic review of adherence to swallow and trismus exercises during radiation therapy for head and neck cancer.

Understanding the barriers and facilitators for prophylactic swallowing and trismus exercises for patients undergoing radiation to the head and neck may help exercise adherence. The analysis reviews all published reports of exercise adherence with a critical appraisal following PRISMA guidelines. A total of 137 potential papers were identified; 20 studies met the inclusion criteria. The most commonly reported facilitators for swallowing and trismus exercises were regular clinician contact and online resources to reinforce instructions, set goals, and manage radiation toxicities. Social support and perceived benefit from exercises were also reported to be of help. The most common barriers to exercise were radiation toxicities, anxiety, feeling overwhelmed with information, and not understanding the reason for the exercises. Understanding facilitators and barriers to adherence is critical when designing exercise interventions for patients undergoing radiation for head and neck cancer.

Association between Swallowing Outcomes and Dose to Critical Swallow Structures in Patients Undergoing Transoral Robotic Surgery and Post-Operative Radiation Therapy.

BACKGROUND: The radiation dose to dysphagia and aspiration-related structures (DARS) for patients undergoing transoral robotic surgery (TORS) and post-operative radiation therapy (PORT) for primary oropharyngeal carcinoma is unknown. METHODS: This prospective study measured swallowing using the MD Anderson Dysphagia Inventory at baseline and then 12-months after PORT. Dosimetric parameters were collected. RESULTS: 19 patients were recruited between 2017 and 2019. Worse swallow function at 12-months after PORT was associated with dose-parameters to the oesophageal inlet muscle, superior pharyngeal constrictor muscle and cervical oesophagus. Mean dose, V50Gy, and V60Gy to the base of tongue and pharyngeal constrictors was significantly lower in those receiving PORT to the neck alone. CONCLUSION: Dose to DARS was lower in patients who received PORT to the neck alone. In patients treated with TORS and PORT, poorer swallowing outcomes at 12 months post-treatment were associated with increased dose to oesophageal inlet muscle, superior constrictor muscle, and cervical oesophagus.

Exercise adherence for patients with trismus after head and neck cancer treatment.

BACKGROUND: Head and neck cancer treatment often leads to trismus, a condition characterized by limited mouth opening. Exercise-based therapy is the most common intervention but there are no clear guidelines as to the optimal exercise regimen. Restorabite™ is a portable and force-regulated trismus device designed to enhance exercise adherence. This study explores the adherence to exercises using Restorabite™ in head and neck cancer patients with trismus and identifies facilitators and barriers to exercise therapy. MATERIALS AND METHODS: Mixed-methods, prospective cohort study undertaken at a quaternary oncology hospital, in Sydney Australia involving participants diagnosed with head and neck cancer diagnosed with trismus (maximal incisal opening under 35 mm). Patients underwent a 10-week individualized trismus program using Restorabite™ with weekly speech pathology reviews. Exercise adherence was tracked through categorized descriptors. Data were collected prospectively at baseline, during 10 weeks of therapy with Restorabite™, and at 6- and 12-month post-trismus exercise. Participants described facilitators of trismus therapy, and barriers to completing the prescribed exercises. Clinical documentation of these responses was then analyzed using content analysis. RESULTS: One-hundred and thirty-five participants were recruited. During the intervention 69% (n = 93) exercised as recommended, 24% (n = 32) exercised less, and 7% (n = 10) exercised more than recommended. At 6 months post-intervention, 55.5% (n = 75) exercised as recommended, 38.5% (n = 52) exercised less, and 4% (n = 6) exercised more. At 12 months, 36% (n = 49) exercised as recommended, 48% (n = 62) exercised less, and 11% (n = 15) exercised more. MIO increased from a mean of 18.6 mm at baseline, to 30.1 mm at the end of the 10-week intervention. This was maintained at 6 and 12 months (31.7 and 32.1 mm, respectively). Adherence to the exercise program was associated with greater improvement in maximum interincisal opening (p < 0.001). Facilitators of adherence included intrinsic motivation, device portability, perceived functional change, and external support tools. Barriers included cancer treatment toxicities, competing priorities, and health challenges. Positive outcomes included functional improvements, while negative outcomes included increased pain. CONCLUSIONS: Seventy-six percent of patients prescribed Restorabite™ performed trismus exercises at or more than the recommended frequency. Facilitators and barriers identified provide insights into factors influencing adherence. Future research should involve comparative studies that compare the adherence and effectiveness of different exercise programs.

Restorabite™: Phase II trial of jaw stretching exercises using a novel device for patients with trismus following head and neck cancer.

Patients treated for oral cancer, may experience restricted mouth opening (trismus). Barriers such as cost have limited the utilization of traditional jaw stretching devices, and consequently, patients experience problems with swallowing, oral care, communication, and cancer surveillance. The safety and efficacy of Restorabite™, a new device designed to overcome these barriers, is evaluated prospectively over 12 months. This phase II investigator-led trial included patients with chronic trismus underwent 10-weeks of trismus therapy using Restorabite™. Safety, adherence, changes in mouth opening, and patient-reported outcomes are presented. 114/120 participants with trismus completed the intervention, and 104 had their progress monitored for 12 months. Thirteen participants withdrew due to tumour recurrence. At the completion of the intervention, mouth opening improved by 10.4 mm (p < .001). This increased to 13.7 mm at 12 months (p < .001). Patient reported outcome all significantly improved and 47 participants were no longer classified as having trismus. There were no serious treatment related adverse events. In patients with trismus following head and neck cancer treatment, a 10-week programme of jaw stretching exercises using Restorbite™ safely improves mouth opening and associated quality of life outcomes with high adherence and the benefits are maintained for 12-months.

Pilot Study of Intensive Trismus Intervention Using Restorabite™ During Unilateral Adjuvant Radiation for Head and Neck Cancer.

Trismus commonly arises after surgery for head and neck cancer (HNC) and its severity is potentiated by postoperative radiotherapy. While the benefit of trismus rehabilitation after surgery and radiotherapy is well established, the evidence during radiotherapy is less clear. This may be due to poor adherence to trismus exercises secondary to acute mucositis. This study assessed the feasibility of using a novel trismus device during adjuvant radiotherapy for HNC in patients with acute postoperative trismus. Prospective single-arm cohort feasibility study. Eligible patients had undergone surgery with curative intent for HNC, planned for adjuvant radiotherapy, and were suitable for trismus rehabilitation. Participants completed a 10-week exercise program using a novel jaw stretching device. Study outcomes were adherence, maximal incisal opening (MIO), and trismus-related function and quality of life scores, assessed at baseline, 10 weeks, and 6 months after commencing exercises. Nine patients diagnosed with trismus after primary surgery were recruited. The mean increase in MIO at 10 weeks was 7.8 mm (range -4 to 15 mm, p = 0.03), and at 6 months was 10.6 mm (range 1-26 mm, p = 0.03). Significant improvements were observed in trismus-related quality of life (Gothenburg Trismus Questionnaire; p = 0.04). Adherence to the exercises was 100% in week 1-2, 67% in weeks 3-6, and 100% at 10 weeks (1 month post radiation). This study demonstrates the feasibility of using a novel jaw stretching device during adjuvant radiotherapy. Further evaluation is warranted to assess the effectiveness of early intervention and prevention of trismus during HNC radiotherapy.Level of Evidence: IV.

Amplification, Resistance, and Kinetics of the Jaw Stretching Device (ARK-JSD): analysis of the force variation and implications for trismus therapy.

PURPOSE: Jaw-stretching devices, including the Amplification, Resistance, and Kinetics of the Jaw (ARK-JSD), are an effective option for treating trismus after head and neck cancer (HNC) treatment. The force, however, that is applied to the patient's jaw is unknown. METHODS: Ten ARK-JSD devices were constructed for each of the levels of resistance (total of 30 samples). Each sample was tested using a Universal Testing Machine (UTM). RESULTS: The easy, medium, and hard ARK-JSD had a mean maximum force of 12.3, 21.0, and 32.7 Newtons (N) at a mean interincisal distance (IID) of 8.0 mm, 13.0 mm, and 16.0 mm, respectively. The force varied by 6.9 N for the easy and 24.1 N for the hard ARK-JSD. Fatigue analysis demonstrated up to 5.5 N loss of force over 10 weeks. CONCLUSION: The ARK-JSD is a low-cost trismus device that can force between 12.3 and 32.7 N. The variation in resistance may impact efficacy. Understanding this variation will assist clinicians and patients using the ARK-JSD for trismus therapy.

Improving the oral function of patients with upper and lower lip tensor fascia lata slings for patients with flaccid facial nerve palsy.

BACKGROUND: Facial nerve paralysis (FNP) often causes decreased quality of life and may lead to significant facial dysfunction. Oral competence is frequently raised as a concern by patients as it impacts nutrition, hydration, social participation, and mental health. This can result in social isolation and reduced capacity to return to vocational roles. Despite its prevalence, it is incompletely understood and rarely described. This study prospectively evaluated the impact that facial nerve static and dynamic reanimation has on oral competence, with a specific focus on speech intelligibility and the oral phase of the swallow. MATERIALS AND METHODS: Patients who had a static or dynamic facial reanimation at Chris O'Brien Lifehouse due to facial nerve paralysis were recruited consecutively between September 2020 and October 2022. Their speech and swallow were analysed using patient reported outcome measures including the speech handicap index and the oral competence questionnaire, and speech intelligibility rated by the patient and their speech pathologist at baseline (up to 2-weeks prior to surgery), then at 6- and 12- months post-surgery. Outcomes were evaluated firstly by a paired analysis (pre- compared to post-operative oral competence outcomes), and secondly by a cohort analysis of static, compared to dynamic reanimation. RESULTS: 19 participants underwent a facial nerve reconstruction (10 static, 9 dynamic and static) due to pre-operative facial nerve paralysis. At 12-months improvements in both the oral competence questionnaire (OCQ) and the speech handicap index (SHI) (score reduced at a rate of 0.3 points per week and the 0.2 points respectively) and that this change met statistical significance (OCQ; p = p < 0.003, SHI; p < 0.001). Patient rated intelligibility increased 0.3 and clinician rated intelligibility increased 0.2 points per week which also significantly improved (p = 0.001 and p < 0.001 respectively). CONCLUSIONS: Both static and dynamic facial reanimation procedures significantly improved both speech and swallowing measures for oral competence at 6- and 12- months post-procedure. There was not a significant difference found between static and dynamic procedures.

Minimum detectable change in occlusal load - normative data for healthy and head and neck cancer populations.

Traditionally, pain has been a signal to de-intensify jaw exercises for trismus to prevent tissue damage. It is unknown whether patients who have undergone surgery or radiotherapy for head and neck cancer have sufficient sensation to detect changes in occlusal load. This study sought to compare the minimum detectable occlusal load in a cohort of patients with head and neck cancer (HNC) and compare this with healthy controls. Twenty patients who were treated for HNC and 20 healthy controls were recruited from a single institution. A purpose-built pressure transducer was used to measure the minimum detectable force (measured in Newtons) applied to the jaw and the interincisal distance. Analysis was conducted using a mixed effects linear regression. The mean minimum detectable occlusal load in patients with HNC was 18.7N compared to 4.5N in healthy controls (mean difference 14.3N, 95% CI 12.2N to 16.4N, p < 0.001). Adjusted IID predicted force (0.15N per-mm IID, 95% CI 0.09 to 0.2, p < 0.001) with a weak interaction between treatment with radiotherapy and IID in HNC patients (p = 0.85). Patients who have been treated for HNC are less sensitive to changes in force applied to the jaw. This is concerning given that most jaw stretching devices use an unregulated and unknown amount of force to achieve greater mouth opening.

Gender differences in perceived speech intelligibility in patients with facial nerve palsy.

PURPOSE: Facial nerve palsy (FNP) affects physical and social function, including speech. There exists discrepancy between professional and patient perception of appearance following FNP; however, speech differences remain unknown. We aimed to compare ratings of speech intelligibility by different listeners. METHOD: Patients were identified through the Sydney Facial Nerve Service. FNP related scoring was obtained using the Sunnybrook Facial Grading System, Sydney Facial Grading Score, Facial Disability Index, and Speech Handicap Index. Intelligibility was scored by a speech-language pathologist, member of the public, and patient using a standardised passage. FNP scoring and intelligibility were compared using interclass coefficients (ICC). RESULT: Forty patients were recruited (females = 20). There was no difference in FNP scoring, nor between the frequency or types of phonemic errors. Observers' rating of intelligibility had an ICC of 0.807, compared with 0.266 and 0.344 for patients compared to the member of the public and speech-language pathologist respectively. Observers rated males and females intelligibility similar (p > 0.05), but females rated their intelligibility lower than males (74.5 ± 12.8 vs. 82.5 ± 8.4, p = 0.025). CONCLUSION: Patients, particularly females, perceive their speech to be less intelligible than observers. Clinicians should be aware of this discrepancy, which does not correlate with physical function.

Construct and discriminant validity testing of the FACE-Q Head and Neck Cancer Module for assessing speech and swallowing outcomes for patients undergoing maxillectomy or mandibulectomy.

BACKGROUND: The FACE-Q H&N is a patient reported outcome measure covering multiple constructs for patients with head and neck tumors. Additional testing is needed to determine suitability in assessing speech- and swallowing-related quality of life and function. METHODS: FACE-Q H&N, The M. D. Anderson Dysphagia Inventory (MDADI), and Speech Handicap Index (SHI) scores were collected from two patient cohorts who had undergone jaw reconstruction. Construct validity was assessed using convergent validity testing and known groups testing to assess discriminant validity. RESULTS: A priori hypotheses testing demonstrated strong correlations (ρ > 0.6, p < 0.05) between FACE-Q H&N eating and drinking, swallowing and eating distress scales with MDADI subscales, and between FACE-Q H&N speech function and distress scales and the SHI. Known groups testing demonstrated all instruments could delineate outcomes among patients who had radiation, advanced tumors, and tracheostomy. CONCLUSION: The FACE-Q H&N may be an alternative for the SHI and MDADI in this patient cohort.

Treatment approaches and outcomes of a head and neck lymphedema service at an Australian comprehensive cancer center.

BACKGROUND: Patients treated for head and neck cancer are at high risk of developing head and neck lymphedema (HNL). We describe outcomes of HNL management at an Australian institution from 2018 to 2020. METHODS: Electronic records from Chris O'Brien Lifehouse were retrospectively reviewed from January 1, 2018 to December 31, 2020. Objective changes in HNL were assessed using The M. D. Anderson Cancer Center (MDACC) HNL rating scale and Assessment of Lymphedema of the Head and Neck (ALOHA). RESULTS: Among the 100 patients referred for management of HNL, surgery was the most frequent treatment modality (80%; 70% with neck dissection) and 69% underwent radiotherapy. Manual lymphatic drainage (MLD) was most often prescribed (96%), followed by self-MLD (93%). Small but significant improvements in ALOHA measurements were observed for 50 patients (50%). Only 5/29 (17%) patients had post-treatment improvements on the MDACC scale. CONCLUSIONS: Standardized, prospective measurement of treatment approaches and outcomes is needed to further evaluate the service.

Virtual reality digital surgical planning for jaw reconstruction: a usability study.

BACKGROUND: Digital surgical planning (DSP) has revolutionized the preparation and execution of the management of complex head and neck pathologies. The addition of virtual reality (VR) allows the surgeon to have a three-dimensional experience with six degrees of freedom for visualizing and manipulating objects. This pilot study describes the participants experience with the first head and neck reconstructive VR-DSP platform. METHODS: An original VR-DSP platform has been developed for planning the ablation and reconstruction of head and neck pathologies. A prospective trial utilizing this platform involving reconstructive surgeons was performed. Participants conducted a simulated VR-DSP planning session, pre- and post-questionnaire as well as audio recordings allowing for qualitative analysis. RESULTS: Thirteen consultant reconstructive surgeons representing three surgical backgrounds with varied experience were recruited. The majority of surgeons had no previous experience with VR. Based on the system usability score, the VR-DSP platform was found to have above average usability. The qualitative analysis demonstrated the majority had a positive experience. Participants identified some perceived barriers to implementing the VR-DSP platform. CONCLUSIONS: Virtual reality-digital surgical planning is usable and acceptable to reconstructive surgeons. Surgeons were able to perform the steps in an efficient time despite limited experience. The addition of VR offers additional benefits to current VSP platforms. Based on the results of this pilot study, it is likely that VR-DSP will be of benefit to the reconstructive surgeon.

Utility of an oral competence questionnaire for patients with facial nerve paralysis.

OBJECTIVE: To investigate the utility of a patient-reported outcome measure that evaluates oral competence; speech and swallowing functions after facial nerve paralysis (FNP). METHODS: The Oral Competence Questionnaire (OCQ) covers 16 questions from known, validated patient-reported outcome measures. The OCQ was completed by 40 patients with facial nerve paralysis (FNP) and 40 healthy controls. The sensitivity of the questionnaire was tested against other validated questionnaires for oral function, speech/swallowing functions, and facial nerve-related disability. Normative data were obtained by administering the OCQ to a group of healthy volunteers. RESULTS: A total of 80 participants completed the OCQ (40 FNP and 40 healthy controls). Strong linear relationships (Spearman correlation coefficients >0.8) were observed between speech intelligibility ratings, objective speech outcomes, and the OCQ. Linear correlations were also noted between OCQ and FDI (Spearman correlation coefficient >0.4). The mean OCQ score for participants with FNP was 28.8 and 0.0 for healthy controls. CONCLUSIONS: This succinct, 16-item questionnaire demonstrated good sensitivity for testing oral competence and oral function for patients with FNP, and the ability to discriminate between patients with FNP from patients with normal facial nerve function.

Velopharyngeal incompetence following transoral robotic surgery for oropharyngeal carcinoma: A scoping review.

PURPOSE: Following transoral robotic surgery (TORS) for oropharyngeal carcinoma (OPC), velopharyngeal incompetence (VPI) is a known consequence that may contribute to swallowing and speech disorders. As the incidence of OPC increases affecting a younger demographic, a better understanding of VPI is required to support speech and swallowing rehabilitation. METHOD: A scoping review was conducted using Arskey & O'Malley's framework. Studies were identified from five databases between 2007 and 2020. The methodological quality was measured with the RevMan Risk of Bias Tool by two independent evaluators. RESULT: A total of seven studies met the inclusion criterion. There was a combined total of 306 participants, their average age was 59.2 years. A high risk of bias and degree of heterogeneity across all seven cohort studies was observed. Validated and instrumental evaluations of VPI were present in two papers, with the majority only reporting the presence or absence of VPI. The incidence of VPI reported in each study ranged from 0 to 53%, (median 3.5%). CONCLUSION: There are few high-quality studies and considerable heterogeneity in the terminology, inclusion criteria and measurement of VPI. Instrumentation, to date, has been rarely used but is necessary for a normed and validated approach to VPI. Based on this review, there is considerable need for larger studies which instrumentally and longitudinally assess VPI as a consequence of TORS, in order to guide patient education and management prior to, and following their surgery.

A pilot study of intensive intervention using a novel trismus device.

PURPOSE: Trismus secondary to head and neck neoplasm treatment impacts upon quality of life, nutrition, oral hygiene, and dentition. Current treatment options for trismus apply unquantified force to the jaw, and in many cases, the device costs are prohibitive. This study aimed to prospectively evaluate the impact of a novel trismus device. METHOD: This single arm cohort study prospectively evaluated the impact of a novel trismus device on maximal incisal opening (MIO), trismus-related function and quality of life scores. Seventeen patients diagnosed with trismus were recruited to undergo a 10-week program using a novel device. The effect of the intervention was assessed by comparing pre- vs post-intervention validated measures. RESULT: A significant improvement in MIO was observed post the 10-week intervention period (12.6 mm). This was associated with an improvement in patient reported trismus symptomology including quality of life, swallowing, speech, and jaw pain. CONCLUSIONS: This pilot study demonstrates the feasibility of a novel device in the treatment of trismus. Further evaluation of this device is warranted to assess efficacy, safety, and cost-effectiveness in a larger cohort with appropriate controls.