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The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial.

ABSTRACT: PURPOSE:To compare the effects of two stretching devices, the TheraBite® Jaw Motion Rehabilitation System™ and the Dynasplint Trismus System®, on maximal mouth opening in head and neck cancer patients. METHODS:Patients were randomly assigned to one of two exercise groups: the TheraBite® Jaw Motion Rehabilitation System™ group or the Dynasplint Trismus System® group. Patients performed stretching exercises for 3 months. During the three study visits, maximal mouth opening was measured and the patients completed questionnaires on mandibular function and quality of life. RESULTS:In our study population (n?=?27), five patients did not start the exercise protocol, eight patients discontinued exercises, and two patients were lost to follow-up. No significant differences regarding the change in mouth opening between the two devices were found. Patients had an increase in MMO of 3.0 mm (IQR -?2.0; 4.0) using the TheraBite® Jaw Motion Rehabilitation System™ and 1.5 mm (IQR 1.0; 3.0) using the Dynasplint Trismus System®. Exercising with either stretching device was challenging for the patients due to the intensive exercise protocol, pain during the exercises, fitting problems with the stretching device, and overall deterioration of their medical condition. CONCLUSIONS:The effects of the two stretching devices did not differ significantly in our study population. The factors described, influencing the progression of stretching exercises, need to be taken into account when prescribing a similar stretching regimen for trismus in head and neck cancer patients. TRIAL REGISTRATION:NTR - Dutch Trial Register number: 5589.

SUBMITTER: van der Geer SJ

PROVIDER: S-EPMC6892373 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial.

van der Geer Sarah J SJ Reintsema Harry H Kamstra Jolanda I JI Roodenburg Jan L N JLN Dijkstra Pieter U PU

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20191107 1

<h4>Purpose</h4>To compare the effects of two stretching devices, the TheraBite® Jaw Motion Rehabilitation System™ and the Dynasplint Trismus System®, on maximal mouth opening in head and neck cancer patients.<h4>Methods</h4>Patients were randomly assigned to one of two exercise groups: the TheraBite® Jaw Motion Rehabilitation System™ group or the Dynasplint Trismus System® group. Patients performed stretching exercises for 3 months. During the three study visits, maximal mouth opening was measu ...[more]

PMID: 31701267

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Project description:BackgroundCurrent treatment for head and neck cancers (HNCs) have led to an improved survival. However, the sequelae of cancer treatment often result in trismus, or reduced mouth opening. The purpose of this report is to identify interventional studies for trismus management in HNC patients.MethodsA search of PubMed, Embase, Cumulated Index to Nursing and Allied Health Literature, and the Cochrane Library was conducted in March 2020 for randomized controlled trials (RCTs) involving interventions for trismus for head and neck cancer within 10 years. Intervention could involve the use of an exercise regime, jaw rehabilitation device, technological device, medication or massage therapy. The primary outcome was the measurement of mouth opening.ResultsEleven RCTs involving a total of 685 patients with HNC were included. Six RCTs evaluated the effectiveness of a jaw mobilization device with exercises; there was no significant benefit of an exercise regime with a jaw mobilization device either initiated before, during or after treatment compared to no exercise. Two RCTs compared 2 intervention groups that involved exercises only, with 1 study assessing the benefit of weekly supervised physical therapy with gum chewing and another evaluating the benefit of immediate (1-2 days) versus delayed (7-10 days) initiation of exercise post-surgery; there was no significant difference between groups in either study. One RCT that recruited only patients with trismus demonstrated that an exercise regime in combination with low-level laser therapy or low-intensity ultrasound had superior results in mouth opening measurements compared to exercise alone. Two RCTs compared intervention groups with and without follow-up reminders; both studies showed a significant improvement in mouth opening measurements in groups with follow-up reminders.ConclusionThis systematic review did not convey a clear consensus as to optimal intervention for trismus in HNC patients. A variety of exercise regimens and jaw rehabilitation devices appear to have comparable effectiveness. However, efforts focused on increasing adherence to a particular intervention protocol may positively impact mouth opening measures in head and neck cancer patients. Also, low-level laser therapy and low-intensity ultrasound coupled with exercise may be beneficial for patients with trismus.

Project description:BackgroundHead and neck cancers (HNCs) are among the most common malignancies, which often require multimodal treatment that includes radiation therapy and chemotherapy. Patients with HNC have a high burden of symptoms due to both the damaging effects of the tumor and the aggressive multimodal treatment. Close symptom monitoring over the course of the disease may help to identify patients in need of medical interventions.ObjectiveThis APCOT (App-Controlled Treatment Monitoring and Support for Head and Neck Cancer Patients) trial is designed to assess the feasibility of monitoring HNC patients during the course of (chemo)radiation therapy daily using a mobile app. Additionally, symptom patterns, patient satisfaction, and quality of life will be measured in app-monitored patients in comparison to a patient cohort receiving standard-of-care physician appointments, and health economy aspects of app monitoring will be analyzed.MethodsThis prospective randomized single-center trial will evaluate the feasibility of integrating electronic patient-reported outcome measures (ePROMs) into the treatment workflow of HNC patients. Patients undergoing definitive or adjuvant (chemo)radiation therapy as part of their HNC treatment at the Department of Radiation Oncology, University Medical Center Freiburg (Freiburg, Germany) will receive weekly physician appointments and additional appointments as requested to monitor and potentially treat symptoms during the course of treatment. Patients in the experimental arm will additionally be monitored daily using a dedicated app regarding their disease- and treatment-related symptoms, quality of life, and need for personal physician appointments. The feasibility of ePROM monitoring will be tested as the primary endpoint and will be defined if ≥80% of enrolled patients have answered ≥80% of their daily app-based questions. Quality of life will be assessed using the validated European Organisation for Research and Treatment of Cancer questionnaires, and patient satisfaction will be measured by the validated Patient Satisfaction Questionnaire Short Form at the initiation, in the middle, and at completion of radiation therapy, as well as at follow-up examinations. Additionally, the number and duration of physician appointments during the course of radiation therapy will be quantified for both ePROM-monitored and standard-of-care patients.ResultsThis trial will enroll 100 patients who will be randomized (1:1) between the experimental arm with ePROM monitoring and the control arm with standard patient care. Recruitment will take 18 months, and trial completion is planned at 24 months after enrollment of the last patient.ConclusionsThis trial will establish the feasibility of close ePROM monitoring of HNC patients undergoing (chemo)radiation therapy. The results can form the basis for further trials investigating potential clinical benefits of detailed symptom monitoring and patient-centered care in HNC patients regarding oncologic outcomes and quality of life.Trial registrationGerman Clinical Trials Register DRKS00020491; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020491.International registered report identifier (irrid)PRR1-10.2196/21693.

Project description:BackgroundFollowing surgery for benign nodular goiter, patients may experience neck and shoulder pain, neck pressure and tightness, choking sensation, altered voice function, and dysphagia leading to decreased short-term quality of life (QoL). This single-blinded randomized controlled trial investigated the effect of post-thyroidectomy rehabilitative neck stretching and movement exercises on these variables including QoL.MethodsPatients undergoing thyroid lobectomy or total thyroidectomy were randomized to perform neck stretching and movement exercises three times daily in four weeks following surgery (intervention group) or conventional follow-up without exercises (control group). Outcome measures were scores in the following questionnaires: Disease-specific Thyroid-Related Patient-Reported Outcome (ThyPRO-39) involving symptoms of "sense of fullness in the neck," "pressure in the throat," and "discomfort swallowing" combined in the multi-item Goiter Symptom Scale, the Voice Handicap-Index-10 (VHI-10), neck and shoulder pain measurement by a numeric rating scale (NRS), and General measure of health (EQ-5D-5L). All scores were assessed prior to surgery and one, two, four weeks, and three months after surgery. Data were analyzed using a linear mixed model.ResultsEighty-nine patients were included and randomized to the control (n = 45) or the intervention group (n = 44). At three months after surgery, both the control and the intervention group experienced large to moderate improvements in the Goiter symptom and Hyperthyroid symptom scale of the ThyPRO questionnaire (p < 0.004). No significant between-group differences were found in any of the other applied scales.ConclusionsThis study confirms that patients experience profound improvements in QoL after surgery for benign nodular goiter. However, early post-thyroidectomy neck stretching and movement exercises did not result in further QoL improvement, reduction in pain or less impacted subjective voice function for patients primarily undergoing thyroid lobectomy. Trial Registration Number NCT04645056 ( https://clinicaltrials.gov ).

Project description:BackgroundHead and neck cancers (HNCs) are very common malignancies, and treatment often requires multimodal approaches, including radiotherapy and chemotherapy. Patients with HNC often display a high symptom burden, both due to the disease itself and the adverse effects of the multimodal therapy. Close telemonitoring of symptoms and quality of life during the course of treatment may help to identify those patients requiring early medical support.ObjectiveThe App-Controlled Treatment Monitoring and Support for Patients With Head and Neck Cancer (APCOT) trial aimed to investigate the feasibility of integrating electronic patient-reported outcomes (ePROs) in the treatment surveillance pathway of patients with HNC during the course of their radiotherapy. Additionally, the influence of app-based ePRO monitoring on global and disease-specific quality of life and patient satisfaction with treatment was assessed.MethodsPatients undergoing radiotherapy for histologically proven HNCs at the Department of Radiation Oncology, University Medical Center Freiburg, Germany, were enrolled in this trial and monitored by weekly physician appointments. Patients were randomized between additional ePRO monitoring on each treatment day or standard-of-care monitoring. Feasibility of ePRO monitoring was defined as ≥80% of enrolled patients answering ≥80% of their daily app-based questions. Quality of life and patient satisfaction were assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), the head and neck cancer module (H&N35), and the validated Patient Satisfaction Questionnaire Short Form (PSQ-18) at the completion of treatment and compared between trial arms.ResultsA total of 100 patients were enrolled in this trial, and 93 patients were evaluable. All patients (100%) in the experimental arm answered ≥80% of the ePRO questions during treatment, reaching the predefined threshold for the feasibility of ePRO monitoring (P<.001 in the binomial test). No clinical or patient-specific factor was found to influence feasibility. Global health and most domains of the general quality of life were comparable between trial arms, but an increased HNC-specific symptom burden was reported by patients undergoing ePRO surveillance. ePRO monitoring resulted in improved patient satisfaction regarding interpersonal manners (P=.01), financial aspects (P=.01), and time spent with a doctor (P=.01).ConclusionsThis trial demonstrated the feasibility of incorporating daily app-based ePRO surveillance for patients with HNC undergoing radiotherapy. Our data, for the first time, demonstrate that telemonitoring in this setting led to increased reporting of HNC-specific symptom burden and significantly improved several domains of patient satisfaction. Further analyses are needed to assess whether our findings hold true outside the context of a clinical trial.Trial registrationGerman Clinical Trials Register DRKS00020491; https://drks.de/search/en/trial/DRKS00020491.

Dataset Information

The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial.

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The use of stretching devices for treatment of trismus in head and neck cancer patients: a randomized controlled trial.

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