Manual Therapy on Oral Opening, Swallow Function and Upper Quarter Mobility on Head and Neck Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de La Frontera
About this trial
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 Opening, Swallow Function, 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 and b) motor control exercises (usual care).
The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
individuals with HNC
individuals over 18 years of age
individuals who have undergone oncological surgery of the head and neck and/or radiotherapy
having finished oncological medical treatment between 3 and 36 months before inclusion
Disqualifiers
sequelae of previous stroke
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
tracheostomized individuals
Trial design
Design model
Parallel
Treatments tested in this trial
Manual Therapy
Other intervention3 times a week, for 6 weeks.
Motor control exercises
Other intervention3 times a week, for 6 weeks.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Manual TherapyExperimental treatment 1 intervention
Group B: Motor ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 weeks2
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
Time frame
6 weeks3
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
Time frame
6 weeks4
Swallowing difficulty
A Visual Analogue Scale (VAS) will be used to register swallowing difficulties, ranging from 0 (no problems) to 10 (impossible to swallow)
Time frame
6 weeksSecondary outcomes
1
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.
Time frame
6 weeks2
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.
Time frame
6 weeks3
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.
Time frame
6 weeks4
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)
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov