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Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study.

ABSTRACT: INTRODUCTION:Patients can develop trismus from their head and neck cancer or as a result of treatment. Trismus affects the jaw muscles and makes mouth opening difficult. To potentially combat trismus, patients could undertake proactive jaw stretching exercises prior to, during and after radiotherapy, although currently these are not the standard of care. METHODS AND ANALYSIS:This is a randomised, open-label, controlled, two-centre feasibility study, to assess the objective and subjective effectiveness and cost-effectiveness of therabite use compared with wooden spatula in ameliorating trismus in patients treated for stage 3 and 4 oral and oropharyngeal cancer, managed either by primary surgery followed by (chemo)radiotherapy or primary (chemo)radiotherapy. The principal objective assessment is measurement of maximum jaw opening. Assessments in all cases will be performed preradiotherapy and again at 3 and 6 months postintervention.Secondary aims of the study will be (1) to assess whether therabite or the wooden spatula intervention improves patients' quality of life, (2) reduce the level of post-treatment clinical management/healthcare use and (3) a nested qualitative study will explore the experience of the patient taking part in the intervention; data will be transcribed verbatim and analysis will be based on content analysis methods using the interview questions as the framework for examination. ETHICS AND DISSEMINATION:North West Greater Manchester granted ethical approval (REC Reference 11/NW/0744). Good Clinical Practice and the Declaration of Helsinki have been adhered to. The results will be presented internationally and submitted to a peer-reviewed journal. Head and neck cancer charities and information websites will also be approached. TRIAL REGISTRATION NUMBER:NCT01733797.

SUBMITTER: Lee R

PROVIDER: S-EPMC5884369 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study.

Lee Rana R Molassiotis Alex A Molassiotis Alex A Rogers Simon N SN Edwards Rhiannon Tudor RT Ryder David D Slevin Nick N

BMJ open 20180330 3

<h4>Introduction</h4>Patients can develop trismus from their head and neck cancer or as a result of treatment. Trismus affects the jaw muscles and makes mouth opening difficult. To potentially combat trismus, patients could undertake proactive jaw stretching exercises prior to, during and after radiotherapy, although currently these are not the standard of care.<h4>Methods and analysis</h4>This is a randomised, open-label, controlled, two-centre feasibility study, to assess the objective and sub ...[more]

PMID: 29602860

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Project description:ImportanceTrismus is highly prevalent in head and neck cancer (HNC) survivorship. Current standards for trismus treatment include various stretch-based exercise protocols as a primary and single treatment modality with limited evidence regarding the role of manual therapy (MT) for this indication.ObjectiveTo assess the effect size and associations of response to MT to increase oral opening in the setting of radiation-associated trismus.Design, setting, and participantsThis retrospective case series was conducted at the University of Texas MD Anderson Cancer Center between 2016 and March 2020 (before COVID-19 interruption) and included 49 disease-free survivors of HNC who were referred for treatment of radiation-associated trismus.InterventionIntraoral MT (including or excluding external head and neck) targeting the muscles of mastication.Main outcomes and measuresMaximum interincisal opening (MIO) before and after the initial MT session compared with serial MT sessions. Covariates were examined to determine the association with response to MT for trismus.ResultsA total of 49 survivors of HNC (13 women [27%]; 24 [49%] 64 years or younger; 25 [51%] 65 years or older; mean [range] of 6.6 [0-33] years postradiotherapy were included, 9 [18.4%] of whom underwent a single MT session; 40 [81.6%] who underwent multiple sessions [mean, 6; median (range), 3 (2-48)]). The MIO improved after a single session by a mean (SD) of 4.1 (1.9) mm (0.45 effect size) and after serial MT sessions by a mean (SD) of 6.4 (4.8) mm with an effect size of 0.7. No covariates were found to be clinically meaningfully associated with MIO improvement following MT.Conclusions and relevanceThe findings of this case series study suggest that MT improved MIO with a medium to large effect size in survivors of HNC with radiation-associated trismus. The results suggest that the largest increase in oral opening was achieved after the initial treatment and although gains were more modest, oral opening continued to improve with serial treatment. Covariates were not associated with MT response, suggesting that patients with clinical features often considered treatment refractory (eg, advanced disease, multiple lines of oncology treatment, ≥5 years posttreatment) may benefit from treatment with MT. Manual therapy may be a beneficial frontline or adjuvant treatment when combined with traditional stretching therapy. A clinically meaningful increase in oral opening has the potential to improve swallow function, speech, pain, and quality of life.

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.

Dataset Information

Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study.

Publications

Protocol for the trismus trial-therabite versus wooden spatula in the amelioration of trismus in patients with head and neck cancer: randomised pilot study.

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