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Manual Therapy for Oral Health on Head and Neck Cancer Survivors
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
Exclusion Criteria:
- Stroke survivors.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
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The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: Manual Therapy
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.
Active Comparator: Control Motor
Control motor (exercise): the session will focus on strengthening and stretching exercises for the intraoral, cervical, mandibular, and shoulder musculature.
No Intervention: Waiting List
Patients waiting list
Interventions
Other: - Manual Therapy
The session will last about 45 minutes, 3 times a week, for 6 weeks.
Other: - Control motor exercises
The session will last about 45 minutes, 3 times a week, for 6 weeks.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Universidad de La Frontera
Temuco, Cautin,
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