Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397742
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2024-04-15
Brief Title:
Assessing the Implementation of Myofascial Techniques in Patients With Accessory Nerve Damage After Oncologic Treatment
Sponsor:
The Greater Poland Cancer Centre
Organization:
The Greater Poland Cancer Centre
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHYSIOACCESS
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
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 Patients 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
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 Patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None