Clinical trial NCT06397742: Assessing the Implementation of Myofascial Techniques in Patients With Accessory Nerve Damage After Oncologic Treatment
Official title: Assessing the Implementation of Myofascial Techniques in Patients With Symptoms of Accessory Nerve Damage After Oncologic Treatment in the Head and Neck Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accessory Nerve Injuries
Physical Therapy
Keywords: head and neck cancer
nerve dysfunction
physical therapy
Lead sponsor: The Greater Poland Cancer Centre
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will recruit patients who underwent surgical therapy for head and neck cancer, with one-sided removal of lymph nodes, and who present symptoms of accessory nerve dysfunction. The group will be recruited from patients who underwent the surgical treatment in Greater Poland Cancer Centre. Outline of the two interventions will be presented to each patient, after which the patient will choose the preferred intervention.

All patients from the study group were treated at the Head and Neck Surgery and Laryngological Oncology Clinic at the Poznań University of Medical Science.

The study group comprised 9 women and 16 men with an average of 51.1 y.o., and the control group comprised 6 women and 17 men with an average of 50,8y.o.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

The aim of this study is 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 dysfunction after surgical head and neck cancer treatment. The study will include patients treated surgically for head and neck cancer with one-sided lymphadenectomy in the head and neck region who present with pain, restricted mobility or muscle atrophy. Recruited patients will be divided into one of two groups: the first group will receive physical therapy including myofascial techniques performed by the physical therapist three times a week for 45 minutes, and the second group will receive a specially designed set of exercises to perform at home three times a week for 45 minutes. The intervention will last six weeks and patients will be assessed before and after intervention. Patient's neuromuscular condition will be examined using surface electromyography (sEMG), pain at rest, during shoulder flexion, and on trapezius muscle palpation will be measured using Visual Analogue Scale, and quality of life will be assessed using modified Neck Dissection Impairment Index (NDII) questionnaire.

Specific aims:

* To create an algorithm of physiotherapeutic procedures in case of the dysfunction of the accessory nerve and related complications.
* To assess the effect of applied techniques on the mobility of the cervical section of the spine.
* To assess the influence of the therapy on the mobility of the shoulder girdle on the post-surgery side.
* To assess the influence of the therapy on patients' pain related discomfort.
* To assess the feasibility of applying sEMG (surface electromyography) to verify the efficiency of the therapy.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Shoulder range of motion: flexion, measured in degrees
timeFrame: within one week pre-intervention and one week after the intervention
measure: Shoulder range of motion: abduction, measured in degrees
timeFrame: within one week pre-intervention and one week after the intervention
measure: Shoulder range of motion: extension, measured in degrees
timeFrame: within one week pre-intervention and one week after the intervention
measure: Shoulder range of motion: rotation, measured in degrees
timeFrame: within one week pre-intervention and one week after the intervention
Secondary outcomes:
measure: Cervical spine range of motion: cervical flexion, measured in degrees
timeFrame: within one week pre-intervention and one week after the intervention
measure: Cervical spine range of motion: cervical extension, measured in degrees
timeFrame: within one week pre-intervention and one week after the intervention
measure: Cervical spine range of motion: cervical lateral flexion, measured in centimetres
timeFrame: within one week pre-intervention and one week after the intervention
measure: Cervical spine range of motion: cervical rotation, measured in centimetres
timeFrame: within one week pre-intervention and one week after the intervention
measure: Passive skeletal muscle tone
timeFrame: within one week pre-intervention and one week after the intervention
measure: Skeletal muscle tone
timeFrame: within one week pre-intervention and one week after the intervention
measure: Skeletal muscle fatigue
timeFrame: within one week pre-intervention and one week after the intervention
measure: 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
timeFrame: within one week pre-intervention and one week after the intervention
measure: 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
timeFrame: within one week pre-intervention and one week after the intervention
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Ewa Tanska
state: Polska
Study officials:
affiliation: Greater Poland Cancer Centre
name: Maciej Górecki, PhD
role: PRINCIPAL_INVESTIGATOR
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