Skip to main content
OpenTrials
Completed

NCT Number: NCT06397742

Assessing the Implementation of Myofascial Techniques in Patients With Accessory Nerve Damage After Oncologic Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical activity

Other

Patients received a set of exercises to execute at home. The home exercise program comprised 12 exercises conducted in sequence:

  • Symmetrical shoulder raises with retraction
  • Rolling upper extremities using a ball
  • Symmetrical shoulder raises
  • Band exercises strengthening the upper girdle and arm
  • Exercise of the shoulder joint flexors
  • Side arm raises in supine position
  • Lateral arm raises in supine position
  • Head raises with rotation in supine position
  • Side arm raises in prone position
  • Front arm raises in prone position
  • Rising and lowering the upper girdle in prone position
  • Neck muscles stretches

Other names: Home exercise program

Physical therapy - myofascial techniques

Other

Physical therapy program comprised five parts. I. Fascial manipulation targeted three most active center of coordination - center of fusion points within head, neck, shoulder, shoulder blade, or chest - during each session, time depending on the patients' adaptability.

II. Manual mobilization of the scar area with each training session including: active myofascial stretching; manual scar mobilization by stretching perpendicularly and in parallel with the scar; soft tissue mobilization by rolling and pulling the surface tissues; myofascial relaxation by breaking through restrictions.

III. Relaxation of muscle contractures using post-isometric muscle relaxation of the scalene muscle, sternocleidomastoid muscle, and neck muscles - until the sessions provided no muscle elongation.

IV. Neuromuscular stimulation with proprioceptive neuromuscular facilitation - included scapula movement patterns, dynamic reversal, stabilizing reversal, upper extremity movement patterns.

Other names: Physical therapy program

Primary outcomes

  1. Shoulder range of motion: flexion, measured in degrees

    Time frame: within one week pre-intervention and one week after the intervention

    Shoulder range of motion: flexion, measured in degrees

  2. Shoulder range of motion: abduction, measured in degrees

    Time frame: within one week pre-intervention and one week after the intervention

    Shoulder range of motion: abduction, measured in degrees

  3. Shoulder range of motion: extension, measured in degrees

    Time frame: within one week pre-intervention and one week after the intervention

    Shoulder range of motion: extension, measured in degrees

  4. Shoulder range of motion: rotation, measured in degrees

    Time frame: within one week pre-intervention and one week after the intervention

    Shoulder range of motion: rotation, measured in degrees

Secondary outcomes

  1. Cervical spine range of motion: cervical flexion, measured in degrees

    Time frame: within one week pre-intervention and one week after the intervention

    Cervical spine range of motion: cervical flexion, measured in degrees

  2. Cervical spine range of motion: cervical extension, measured in degrees

    Time frame: within one week pre-intervention and one week after the intervention

    Cervical spine range of motion: cervical extension, measured in degrees

  3. Cervical spine range of motion: cervical lateral flexion, measured in centimetres

    Time frame: within one week pre-intervention and one week after the intervention

    Cervical spine range of motion: cervical lateral flexion, measured in centimetres

  4. Cervical spine range of motion: cervical rotation, measured in centimetres

    Time frame: within one week pre-intervention and one week after the intervention

    Cervical spine range of motion: cervical rotation, measured in centimetres

  5. Passive skeletal muscle tone

    Time frame: within one week pre-intervention and one week after the intervention

    Passive skeletal muscle tone in the upper trapezius on both sides, measured by surface electromyography (sEMG) amplitude

  6. Skeletal muscle tone

    Time frame: within one week pre-intervention and one week after the intervention

    Skeletal muscle tone in the upper trapezius on both sides, measured at one second of muscle activation using sEMG amplitude

  7. Skeletal muscle fatigue

    Time frame: within one week pre-intervention and one week after the intervention

    Skeletal muscle fatigue in the upper trapezius on both sides, measured as the difference between sEMG amplitude at one second and at the last second of muscle activation

  8. 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

    Time frame: 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

  9. 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Greater Poland Cancer Centre

Other

Registry information

Official study title

Assessing the Implementation of Myofascial Techniques in Patients With Symptoms of Accessory Nerve Damage After Oncologic Treatment in the Head and Neck Regions

Acronym: PHYSIOACCESS

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 3, 2024
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.