Neoplasms

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Musculoskeletal Diseases

Head and Neck Neoplasms

Trismus

Muscle Cramp

Spasm

Neuromuscular Manifestations

Neurologic Manifestations

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.

Control motor (exercise): the session will focus on strengthening and stretching exercises for the intraoral, cervical, mandibular, and shoulder musculature.

The session will last about 45 minutes, 3 times a week, for 6 weeks.

Manual Therapy

Control motor exercises

Barbara Burgos, PhD

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.

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.

Manual Therapy for Oral Health on Head and Neck Cancer Survivors

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

MMO will be assessed with a sliding calliper measuring the inter-incisor distance asking the patients to open the mouth as maximum as possible.

TMD will be assessed with the Fonseca Anamneses Index, that classifies TMD as no dysfunction, light dysfunction, moderate dysfunction or severe dysfunction

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

A Visual Analogue Scale (VAS) will be used to register swallowing difficulties, ranging from 0 (no problems) to 10 (impossible to swallow)

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.

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.

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.

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)

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.

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.

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.

Shoulder pain and disability index (SPADI) will be used to evaluate pain and disability perception of the patients at shoulder level.

Questionnaire EORTC QLQ-C30 will be used for measuring quality of life

Questionnaire EORTC QLQ-H\&N43 will be used for measuring quality of life specifically in survivors of head and neck cancer

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

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.

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).

Universidad de La Frontera

Wounds and Injuries

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Fibrosis

Radiation Fibrosis Syndrome

Pneumonia

Radiation Pneumonitis

Syndrome

Radiation Injuries

Lung Diseases

Lung Diseases, Interstitial

Respiratory Tract Diseases

Lung Injury

The first ten subjects will be enrolled in a pilot study. The following sixty subjects will be separated randomly to experimental group and control group.

The first ten subjects and the experimental group will be arranged manual therapy and rehabilitation for six months.

The control group will be arranged rehabilitation.

1. release and stretch the muscles and fascia around shoulder girdle、upper arm and forearm;
2. massage the masseter muscle and temporalis muscle;
3. mobilization of the temporomandibular joint, the thoracic and cervical spine, shoulder, and elbow.

manual therapy

include the stretching of the neck, facial and oral movement training, and swallowing training

Speech therapy

Tsung-Hsien Yang, MD

TsungHsien Yang

The subjects in this study are the patients with head and neck cancer after completion of the radiotherapy. Radiation-induced fibrosis is inevitable and there is no effective treatment to prevent it. Therefore, there are two parts in this study :

The first part is a pilot study. There will be 10 subjects included and manual therapy and rehabilitation will be arranged for 6 months. The manual therapy would be once a week at most, and the rehabilitation would be twice a week at most.

The second part is a randomized controlled study. 60 patients would be randomized divided into two groups. The group 1 is manual therapy(once a week at most) and rehabilitation(twice a week at most), and the group 2 is rehabilitation only(twice a week at most). Patients would be evaluated at baseline, 3rd, 6th, and 12th month. The evaluation is including the degree of superficial soft tissue fibrosis, numerical rating scale of pain, range of motion(neck), range of motion(shoulder), width of mouth opening, EORTC QLQ C30, EORTC QLQ H\&N 35, and functional oral intake scale. Besides, swallowing video fluoroscopy would be done at baseline, 6th, and 12th month.

When the subject completes the evaluation in the 12th month, the study is ended.

Because the radiation-induced fibrosis is progressed with time, we will follow up the condition of subjects at the next year and the following third year.

The subjects in this study are the patients with head and neck cancer after completion of the radiotherapy. Radiation-induced fibrosis is inevitable and there is no effective treatment to prevent it now. Therefore, there are two parts in this study :

The first part is a pilot study. There will be 10 subjects included and manual therapy and rehabilitation will be arranged for 6 months. The manual therapy would be once a week at most, and the rehabilitation would be twice a week at most.

The second part is a randomized controlled study. 60 patients would be randomized divided into two groups. The group 1 is manual therapy(once a week at most) and rehabilitation(twice a week at most), and the group 2 is rehabilitation only(twice a week at most).

The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

including neck flexion, extension, right and left lateral flexion, and lateral rotation

in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.

to measure the degree of bilateral shoulder, including flexion, extension, abduction, adduction, external rotation, and internal rotation

measure the maximum interincisal opening and range of the jaw and mouth

the most widely used questionnaire for cancer patients; explore aspects of quality of life assessment, evaluation and interpretation.

questionnaire for head and neck cancer patients.

evaluate the pain degree(0\~10); higher scores mean a worse outcome

Observe that the patient swallows items with different thicknesses and textures via using a special real-time form of x-ray. This examination allows us to test the ability to swallow safely and effectively.

Chang Gung Memorial Hospital

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Carcinoma

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.

Katherine A Hutcheson

This trial studies how well manual therapy works in treating fibrosis-related late effect dysphagia in head and neck cancer survivors. Manual therapy is the use of massage and stretching exercises to increase blood flow and muscle movement in the neck, throat, jaw, and mouth, which may help to improve swallowing ability and range of motion in participants who have had treatment for head and neck cancer.

PRIMARY OBJECTIVES:

I. To determine the feasibility and safety of manual therapy for treatment of fibrosis-related dysphagia in head and neck cancer survivors.

SECONDARY OBJECTIVES:

I.To estimate effect size, dose-response (number of treatment sessions to normalized cervical range of motion), and durability of manual therapy for improving cervical range of motion in head and neck cancer survivors with fibrosis-related late dysphagia.

II. To examine functional outcomes after manual therapy in head and neck cancer survivors with fibrosis-related late effects and their association with change in dysphagia grade, cervical extension, and other cofactors.

OUTLINE:

Participants receive 10 manual therapy sessions performed by a speech pathologist during weeks 1-6. After completion of 6 weeks of therapy, participants perform manual therapy at home daily for 6 weeks.

Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors

Manual Therapy for Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors: The Pilot MANTLE Trial

Will be determined by completion rate. Completion rate will be defined by completion of the 6 week clinical manual therapy (MT) program without withdrawing and attending a minimum of 2 sessions and the post-treatment assessment. Session attendance will be monitored separately to assess adherence and fidelity. Will summarize fidelity and adherence to the standard MT protocol using quantitative and qualitative methods.

Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events will be tabulated and will be monitored by the trial Data Safety Monitoring Board.

Will be determined by cervical range of motion (CROM). CROM for each anatomic plane measured by goniometer.

Measured by videofluoroscopy using the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) and Computational Analysis of Swallowing Mechanics (CASM).

Measured by the MD Anderson Dysphagia Inventory (MDADI).

Measured by the MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN).

Measured by the Common Terminology Criteria for Adverse Events and Head and Neck Lymphedema and Fibrosis Scale.

Measured by the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN).

Electromyography (EMG) scores are based on a 4-point denervation potentials grade with '0' being 'none' and '4' being 'full interference patterns of potentials'

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Behaviors and Mental Disorders

Pain

Quality of Life

40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.

Manual therapy

Carolina Fernández-Lao, PhD

People receiving a head and neck cancer treatment often do not find an adequate therapeutic response for the side effects derived from this treatment. The objective of this study is to assess the effectiveness of a physical recovery program based on manual therapy over these problems.

Previous studies have shown the effectiveness of this type of programs on patients who have had cancer in other locations with clinically relevant results. There is a shortage of proposals for this subgroup of patients that require special attention. This project intends to carry out an experimental randomized controlled study with 84 patients treated of head and neck cancer who will be assigned randomly to the study groups: a) manual therapy program or, b) control group. The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 months of patient follow-up.

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 months after finishing the treatment.

Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)

3C-CUIDATE: Efectividad de un Programa de Recuperación Física en el Tratamiento de Las Secuelas Musculoesqueléticas, Funcionales y de Calidad de Vida en Pacientes de Cáncer de Cabeza y Cuello.

Questionnaire EORTC QLQ-C30 was used for measuring quality of life

Questionnaire EORTC QLQ-H\&N-35 was used for measuring quality of life specifically in survivors of head and neck cancer

Visual Analogue Scale was used for evaluating pain intensity at cervical, temporomandibular joint, face and shoulder levels bilaterally.

This consisted of a 10 cm horizontal line with the words "no pain" at the left extreme (0) and "pain as bad as it could be" at the right extreme (10)

Pressure algometry (Force Dial DFK 20 analogue algometer, Wagner, Greenwich, USA) was 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.

Shoulder active range of motion (AROM) was assessed with a two-arms goniometer joined by a 360º protractor with the patient lying on a supine position. Cervical AROM was measured in a upright sitting position with a range of motion instrument (Performance Attainment Associates, Spine Products)

Shoulder pain and disability index (SPADI) was used to evaluate pain and disability perception of the patients at shoulder level.

A digital dynamometer with adjustable grip (TKK 5101 Grip-D; Takei, Tokyo, Japan) was used to assess handgrip strength. Patients were standing in a upright position with the elbow in complete extension. Test was performed 3 times per hand, alternating both hands, with a 1-minute rest between trials.

Endurance of deep cervical flexor muscles was 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.

International Fitness Scale (IFIS) was 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

Mouth opening was evaluated with a sliding calliper measuring the inter-incisor distance asking the patients to open the mouth as maximum as possible

The presence of temporomandibular disorders (TMD) was assessed with the Fonseca Anamneses Index, that classifies TMD as no dysfunction, light dysfunction, moderate dysfunction or severe dysfunction

Piper Fatigue Scale - revised (PFS-r) was used to measure fatigue perception in head and neck cancer patients. It consists of 22 items divided into 4 subscales: behaviour, affection, emotional and cognitive. Each item is evaluated in a Visual Analogue Scale ranging from 0 to 10.

Fatigue perceived at the assessment moment was measured with a Visual Analogue Scale ranging from 0)no fatigue to 10) maximum fatigue perceived

To evaluate sleep quality, Pittsburgh Sleep Quality Index (PSQI) was the instrument used. It consists of 19 self-rated questions related to sleep quality, including estimates of sleep duration and latency and the frequency and severity of specific sleep-related problems.

Sleeping disorders were evaluated with a Visual Analogue Scale rating from 0)no disturbances to 10)impossible to sleep

Perception of anxiety at the assessment moment was measured with a Visual Analogue Scale rating from 0)no anxiety to 10)maximum anxiety perceived

Eating Assessment Tool (EAT-10) was 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

A Visual Analogue Scale was used to register swallowing difficulties, ranging from 0)no problems to 10)impossible to swallow

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Manual Therapy for Oral Health on Head and Neck Cancer Survivors	NCT06148077	Head and Neck C... Trismus Dysfunction	Manual Therapy Control motor e...	18 Years -	Universidad de La Frontera
The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer	NCT04850170	Radiation-Induc...	manual therapy Speech therapy	20 Years -	Chang Gung Memorial Hospital
Manual Therapy in Treating Fibrosis-Related Late Effect Dysphagia in Head and Neck Cancer Survivors	NCT03612531	Cancer Survivor Dysphagia Fibrosis Head and Neck C...	Manual Therapy	18 Years -	M.D. Anderson Cancer Center
Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)	NCT04145180	Head and Neck C... Pain Dysfunction	Manual therapy	18 Years - 75 Years	Universidad de Granada
The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer	NCT04850170	Radiation-Induc...	manual therapy Speech therapy	20 Years -	Chang Gung Memorial Hospital
Effectiveness of a Physical Recovery Program for Head and Neck Cancer Patients (3C-CUIDATE)	NCT04145180	Head and Neck C... Pain Dysfunction	Manual therapy	18 Years - 75 Years	Universidad de Granada

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