Manual Therapy for Oral Health on Head and Neck Cancer Survivors

Study Overview
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Brief Summary
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Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients. The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on oral health, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors. Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises, b) control motor exercises (usual care) and, c) waiting list. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

Detailed Description
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Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

Official Title
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Manual Therapy for Oral Health and Quarter Superior Mobilization on Head and Neck Cancer Survivors: a Randomized, Controlled Pilot Trial

Conditions
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Head and Neck Cancer, Trismus, Dysfunction

Intervention / Treatment
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* Other: Manual Therapy
* Other: Control motor exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have ended their treatment for head and neck cancer in the previous 6-24 months To have no metastasis or active cancer To have trismus (MMO<35 mm) Exclusion Criteria: Stroke survivors. Structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs. Active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area. Individuals with tracheostomies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy<br>Manual Therapy-based intervention: the session will be performed with the patient in a supine position. If they cannot reach this position, it can be done with the patient sitting in a chair to receive the treatment. The selected maneuvers will focus on the intraoral, cervical, mandibular, and shoulder regions. Afterward, motor control exercises will be conducted. | Other: Manual Therapy<br>* The session will last about 45 minutes, 3 times a week, for 6 weeks.<br>|
| Active Comparator: Control Motor<br>Control motor (exercise): the session will focus on strengthening and stretching exercises for the intraoral, cervical, mandibular, and shoulder musculature. | Other: Control motor exercises<br>* The session will last about 45 minutes, 3 times a week, for 6 weeks.<br>|
| No Intervention: Waiting List<br>Patients waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal mouth opening (MMO) | MMO will be assessed with a sliding calliper measuring the inter-incisor distance asking the patients to open the mouth as maximum as possible. | 6 weeks | 
| Temporomandibular disorders (TMD) | TMD will be assessed with the Fonseca Anamneses Index, that classifies TMD as no dysfunction, light dysfunction, moderate dysfunction or severe dysfunction | 6 weeks | 
| Swallowing function | Eating Assessment Tool (EAT-10) will be used to evaluate self-reported swallowing impairments. It is a 5 point Likert scale rating from no impairment to severe problem. The sum of all items contained on the questionnaire is used as the overall score, suggesting an abnormal swallowing when score is higher than 3 | 6 weeks | 
| Swallowing difficulty | A Visual Analogue Scale (VAS) will be used to register swallowing difficulties, ranging from 0 (no problems) to 10 (impossible to swallow) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder active range of motion (AROM) | The active range of motion (AROM) of flexion, abduction, and external and internal rotations will be assessed bilaterally. For measurement, a manual goniometer with two arms and a range of 360º will be used. | 6 weeks | 
| Cervical active range of motion (AROM) | The active range of motion (AROM) of cervical flexion, extension, lateral flexion, and rotation will be assessed. For this purpose, a cervical range of motion instrument (CROM) will be used. | 6 weeks | 
| Deep cervical flexors endurance | Endurance of deep cervical flexor muscles will be assessed with the deep cervical flexor endurance test, with the patient in a supine lying position with the examiner's hands under his/her head and being told to fold the chin completely to the sternum and raising the head as minimum as possible without touching examiner's hands. Time is counted from when the patient lift his/her head until when he/she can no longer maintain the position. | 6 weeks | 
| Muscle Function Test | Defined for the upper fibers of the trapezius, will be used as a test to assess shoulder muscle strength. With the subject in a seated position and arms at both sides of the trunk, they will be asked to push caudally-cranially against the evaluator's hand, placed on their shoulder. The muscle function scale ranges from 0 (complete absence of muscle contraction) to 5 (normal muscle response) | 6 weeks | 
| Isometric handgrip strength | A digital dynamometer with adjustable grip will be used to assess handgrip strength. The patient will be asked, while in a seated position, holding a dynamometer, with the elbow flexed at 90° and the shoulder in a neutral position, to perform a grip with maximum effort. Three attempts will be made with each hand (a total of 6 attempts), with a 1-minute rest between each attempt. The average of the three attempts will be calculated for data analysis. | 6 weeks | 
| Pain Intensity | At the cervical and temporomandibular joint levels (bilaterally), assessment will be conducted using a validated Visual Analog Scale (VAS): a horizontal line measuring 10 cm in length, with no pain at its left end (score 0) and maximum pain at its right end (score 10). Patients will be asked to mark the intensity of perceived pain during their day-to-day activities by placing a cross on the line. | 6 weeks | 
| Pressure pain thresholds | Pressure algometry will be assessed over the temporalis, masseter, upper trapezius and levator scapulae muscles and the C5-C6 zygapophyseal joint, the sternoclavicular joint and the tibialis anterior muscle as a distant reference muscle.Each point to be evaluated will be analyzed three times with a 30-second interval between assessments, and the arithmetic mean of the three measurements will be used for subsequent statistical analysis. | 6 weeks | 
| Shoulder pain and disability perception | Shoulder pain and disability index (SPADI) will be used to evaluate pain and disability perception of the patients at shoulder level. | 6 weeks | 
| Health-related quality of life | Questionnaire EORTC QLQ-C30 will be used for measuring quality of life | 6 weeks | 
| Health-related quality of life 2 | Questionnaire EORTC QLQ-H&N43 will be used for measuring quality of life specifically in survivors of head and neck cancer | 6 weeks | 
| Physical Fitness | International Fitness Scale (IFIS) will be used to evaluate perceived physical fitness. It contains 4 physical fitness elements (cardiorespiratory endurance, muscular strength, speed/agility and flexibility) to categorize into 5 options, from very poor to very good | 6 weeks | 
| Satisfaction with the treatment | It will be determined through a pre-designed questionnaire consisting of 6 items, including 1 item for overall satisfaction with scores ranging from 0 to 10, and 5 dichotomous response items (yes/no), where the patient can provide reasons for their response. This instrument has been previously used for this purpose. | 6 weeks | 
| Adverse Events (AE) | Safety will be recorded in terms of adverse events, defined as any unfavorable change in health that occurs during the intervention. Each adverse event will be characterized based on severity (Grade 1 [mild] to 5 [death]), expectation (expected or unexpected), and potential relationship with study participation (unrelated, possibly related, or related to the study) using the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). | 6 weeks |