Assessing the Implementation of Myofascial Techniques in Patients With Symptoms of Accessory Nerve Damage After Oncologic Treatment in the Head and Neck Regions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Shoulder range of motion: rotation, measured in degrees
研究概览
简要总结
The majority of head and neck cancers develop locally and regionally. Therefore, to reduce the risk of metastasis, 90% of surgeries performed in the head and neck area include the removal of regional lymph nodes and delivery of radiotherapy.
As a consequence of radical surgery affecting the lymphatic system in the neck area, there exists a risk of damage to the cervical plexus branch (C1-C4) or the accessory nerve. Patients with damage to this nerve develop disability involving limitations to the head flexion, extension, and rotation, asymmetric shoulder blades, disturbed shoulder joint abduction, flexion, and external rotation (supination). Additionally, patients often suffer from pain, numbness, swelling, and body asymmetry.
Subject literature does not describe in a detailed and comprehensive way the physiotherapeutic procedures to be applied in case of a damaged accessory nerve as a complication after cancer treatment. Unfortunately, it is often related to patients' limited access to an effective therapy. Available information on the rehabilitation procedures is limited and it mostly focuses on exercise recommendations. An analysis of the subject literature does not show any information on the efficiency of applying the myofascial techniques for treating deficiencies related to the damage of the accessory nerve.
In the current project the investigators plan to assess the effectiveness of a physical therapy intervention comprising myofascial techniques as compared to a set of exercises designed for performing individually in head and neck cancer patients with accessory nerve damage after surgical head and neck cancer treatment. The primary outcome will be physiotherapeutic procedures to be applied in case of a damaged accessory nerve as a complication after cancer treatment. The secondary outcomes will include the efficiency of applying the myofascial techniques for treating deficiencies related to the damage of the accessory nerve.
详细描述
The majority of head and neck cancers develop locally and regionally. Therefore, to reduce the risk of metastasis, 90% of surgeries performed in the head and neck area, include the removal of regional lymph nodes and delivery of radiotherapy.
As a consequence of radical surgery affecting the lymphatic system in the neck area, there exists a risk of damage to the cervical plexus branch (C1-C4) or the accessory nerve. However, depending on the cancer stage, in numerous cases it is possible to successfully save bodily structures and maintain continuation of nerves.
The analysis of complications shows that about 80% of patients communicate subjective discomforts of upper limb on the side of the surgery. After surgery treatment including lymphadenectomy (lymph node dissection) in the head and neck area, 60% of patients suffer from the damage or dysfunction of the accessory nerve.
As a consequence, there are numerous symptoms limiting the normal functioning of a patient. Among the most frequent symptoms of accessory nerve damage is a muscle dysfunction on the side of the nerve damage (trapezius muscle, sternocleidomastoid muscle). As a result of the accessory nerve damage, patients develop disability due to limitations to the head flexion, extension, and rotation, asymmetric shoulder blades, disturbed shoulder joint abduction, flexion, and external rotation (supination). Additionally, patients suffer from pain, numbness, swelling, and body asymmetry. Subject literature does not describe in a detailed and comprehensive way the physiotherapeutic procedures to be applied in case of a damaged accessory nerve as a complication after cancer treatment. Unfortunately, endurance of the impairment is often related to patients' limited access to an effective therapy
Purpose of the research:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated surgically for head and neck cancer with one-sided lymphadenectomy in the head and neck region,
- •symptoms of damage to the accessory nerve,
- •Eastern Cooperative Oncology Group (ECOG) scale 0-2,
排除标准
- •local recurrence,
- •distant metastases,
- •cardiorespiratory failure,
- •pain symptoms exceeding patients adaptability,
- •decline of the patient's level of functioning to 3-4 in ECOG scale.
结局指标
主要结局
Shoulder range of motion: rotation, measured in degrees
时间窗: within one week pre-intervention and one week after the intervention
Shoulder range of motion: rotation, measured in degrees
Shoulder range of motion: flexion, measured in degrees
时间窗: within one week pre-intervention and one week after the intervention
Shoulder range of motion: flexion, measured in degrees
Shoulder range of motion: abduction, measured in degrees
时间窗: within one week pre-intervention and one week after the intervention
Shoulder range of motion: abduction, measured in degrees
Shoulder range of motion: extension, measured in degrees
时间窗: within one week pre-intervention and one week after the intervention
Shoulder range of motion: extension, measured in degrees
次要结局
- Cervical spine range of motion: cervical lateral flexion, measured in centimetres(within one week pre-intervention and one week after the intervention)
- Cervical spine range of motion: cervical flexion, measured in degrees(within one week pre-intervention and one week after the intervention)
- Quality of life after neck dissection, scored based on the Neck Dissection Impairment Index (NDII) questionnaire, a single scale with range of points 5-50, with a higher score meaning worse quality of life(within one week pre-intervention and one week after the intervention)
- Cervical spine range of motion: cervical extension, measured in degrees(within one week pre-intervention and one week after the intervention)
- Skeletal muscle fatigue(within one week pre-intervention and one week after the intervention)
- Cervical spine range of motion: cervical rotation, measured in centimetres(within one week pre-intervention and one week after the intervention)
- Passive skeletal muscle tone(within one week pre-intervention and one week after the intervention)
- Assessment of pain symptoms using Visual Analogue Scale (VAS) measured at rest, during shoulder flexion, and during trapezius muscle palpation; a single scale questionnaire, with range of points 1-10, with higher score meaning more intense pain(within one week pre-intervention and one week after the intervention)
- Skeletal muscle tone(within one week pre-intervention and one week after the intervention)