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

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

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

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 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.

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

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 range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year

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

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.

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

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

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

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

Inclusion Criteria : Age > 20 years Head and neck cancer After Completion of radiation therapy for 4 to 6 weeks Be willing to accept manual therapy and long-term follow up Exclusion Criteria : Recurrence, metastatic cancer, or concurrent second cancer With post-radiation dermatitis at neck or shoulder Current pregnancy or lactation Life expectancy of < 12 months.

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Krisciunas GP, Vakharia A, Lazarus C, Taborda SG, Martino R, Hutcheson K, McCulloch T, Langmore SE. Application of Manual Therapy for Dysphagia in Head and Neck Cancer Patients: A Preliminary National Survey of Treatment Trends and Adverse Events. Glob Adv Health Med. 2019 Apr 24;8:2164956119844151. doi: 10.1177/2164956119844151. eCollection 2019.

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