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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
70
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.
include the stretching of the neck, facial and oral movement training, and swallowing training
New Taipei Municipal Tucheng Hospital
New Taipei City, Taiwan
RECRUITINGChange from Baseline range of motion, neck at the 3rd month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Time frame: baseline and 3rd month
Change from Baseline Functional oral intake scales at 3rd month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Time frame: baseline and 3rd month
range of motion, shoulder
to measure the degree of bilateral shoulder, including flexion, extension, abduction, adduction, external rotation, and internal rotation
Time frame: measure the range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Width of mouth opening
measure the maximum interincisal opening and range of the jaw and mouth
Time frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
EORTC QLQ C30
the most widely used questionnaire for cancer patients; explore aspects of quality of life assessment, evaluation and interpretation.
Time frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
EORTC H&N 35
questionnaire for head and neck cancer patients.
Time frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Numerical rating scale of pain
evaluate the pain degree(0\~10); higher scores mean a worse outcome
Time frame: at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year
Swallowing Video Fluoroscopy
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.
Time frame: at baseline, the 6th month, and the 12th month
Change from Baseline range of motion, neck at the the 6th month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Time frame: baseline and 6th month
Change from Baseline range of motion, neck at the the 12th month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Time frame: baseline and 12th month
Change from Baseline range of motion, neck at the the 2nd year
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Time frame: baseline and 2nd year
Change from Baseline range of motion, neck at the the 3rd year
including neck flexion, extension, right and left lateral flexion, and lateral rotation
Time frame: baseline and 3rd year
Change from Baseline Functional oral intake scales at 6th month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Time frame: baseline and 6th month
Change from Baseline Functional oral intake scales at 12th month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Time frame: baseline and 12th month
Change from Baseline Functional oral intake scales at 2nd year
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Time frame: baseline and 2nd year
Change from Baseline Functional oral intake scales at 3rd year
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Time frame: baseline and 3rd year
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