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Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Spinal Accessory Nerve Injury, Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial Release Technique
Exercise
Scar Tissue Massage
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, Shear Wave Elastography, Myofascial Release, Cancer Rehabilitation, Physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18-year-old
  • Having modified or functional neck dissection
  • 60< Karnofsky Score
  • Spinal accesory nerve injury symptoms, such as dropped and winged scapula and decreased shoulder abduction in physical examination.

Exclusion Criteria:

  • Metastasis
  • Having Radiotherapy- Chemoradiotherapy
  • Having severe psychological problem
  • Having previous shoulder injury/ scapular dyskinesia

Sites / Locations

  • Yeditepe University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Participants in the control group will receive usual care ( standard physical therapy program)

Particiapnts in intervevention group will receive both usual care and myofascial release techniques

Outcomes

Primary Outcome Measures

Shoulder pain and disability level
Shoulder Pain and Disability Index
Muscle Stiffness
It will be measured by Shear Wave Elastography in relax and contracted state of muscle Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral
Muscle Thickness
It will be measured by Shear Wave Elastography Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral
The Quality of Life
The Functional Assessment of Chronic Illness Therapy system of Quality of Life- Head and Neck (FACT H&N Turkish Version)
Shoulder Abduction
Active range of motion will be measured by goniometer for both side
Shoulder Flexion
Active range of motion will be measured by goniometer for both side
Shoulder Internal Rotation
Active range of motion will be measured by goniometer for both side
Shoulder External Rotation
Active range of motion will be measured by goniometer for both side
Neck Rotation
Active range of motion will be measured by goniometer for both side
Neck Flexion
Active range of motion will be measured by goniometer for both side
Neck Extension
Active range of motion will be measured by goniometer for both side
Neck Lateral Flexion
Active range of motion will be measured by goniometer for both side

Secondary Outcome Measures

Mandibular depression
Gap between two incisor teeth with full opened mouth

Full Information

First Posted
May 23, 2022
Last Updated
January 1, 2023
Sponsor
Yeditepe University
Collaborators
Yeditepe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05399953
Brief Title
Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer
Official Title
Investigation of Effects of Physioherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeditepe University
Collaborators
Yeditepe University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
As the head and neck cancer (HNC) survival rate has increased and therefore, the focus of post-treatments is to improve the quality of patients' life by decreasing the side effects. Treatment of HNC leads to acute and chronic soft tissue damage, and functional loss. However, patients with HNC need having rehabilitation throughout the post-treatment phase so as to improve functional outcomes because of the long term side effects. Chronic shoulder morbidity is one of the complications after surgery due to spinal accesory nerve injury. Moreover, pain, dysphonia, and musculoskeletal impairments are observed in the individuals after the treatments and the patients also have trouble swallowing problems, loss of taste, dry mouth, trismus, nausea, vomiting, and fatigue during and after therapy. Since there is limited research on the usage of manual therapy techniques in HNC patients, this study aims to investigate muscle changes after surgery and the effectiveness of physiotherapy on muscle material behaviour from a biomechanical perspective by using shear wave elastography. In this respect, the hypothesis is: H0: Physical therapy interventions do not impact mechanical properties of muscle, pain, quality of life, cervical and shoulder functionality in HNC patients after neck dissection. H1: Physical therapy interventions will improve mechanical properties of muscle, pain, quality of life, cervical and shoulder functionality in HNC patients after neck dissection.
Detailed Description
As the HNC survival rate has increased and therefore, the focus of post-treatments is to improve the quality of patients' life by decreasing the side effects. Treatment of HNC leads to acute and chronic soft tissue damage, and functional loss. However, patients with HNC need having rehabilitation throughout the post-treatment phase so as to improve functional outcomes because of the long term side effects. Chronic shoulder morbidity (70% of patients) is one of the common complications after surgery, whereas 84% of survivors complain of their physical appearance due to the remaining head and neck lymphedema (HNL) after radiotherapy. Moreover, pain, dysphonia, and musculoskeletal impairments are observed in the individuals after the treatments and the patients also have trouble swallowing problems, loss of taste, dry mouth, trismus, nausea, vomiting, and fatigue during and after therapy. Materials might behave in different stress-strain relationships, and it is represented by a stress-strain curve, a basic descriptor of material.Thanks to the stress-strain diagram, differences between materials can be determined such as stiffness, hardness and toughness. Several concepts describe material properties in addition to a stress-strain diagram. For instance, a homogeneous material is one whose properties are not affected by location within the material, anisotropic material is one whose properties are free of direction, and incompressible material retains its volume during deformation. However, the behaviour of soft tissue is anisotropic due to its fibre contents, its constitutive behaviour is nonlinear and incompressible, and it is heterogeneous material owing to its composition, but it can be homogenized under macroscopic analysis. Due to the complexity of soft tissue, its mechanical behaviour is highly affected by density, collagen and elastin's structural arrangement, topographical site, function, and hydrated matrix of proteoglycans. In other words, mechanical properties of soft tissues are related to shape, genetics, age , physical and chemical environmental conditions like strain rate, osmotic pressure and Ph, temperature, which affects skeletal muscle's contractile properties. It is known that deformable-body changes shape when it is exposed to an external force. In general, several constitutive relations govern the stress and strain relations, for example, plasticity, viscoelasticity, linear elastic, hyperelasticity so on. It is common to use hyperelastic models (i.e. time-independent) so as to determine the association of the stress-strain of soft tissue, even though the biological soft tissues mechanical behaviour is time-dependent . These models are based on the strain energy density which is the energy stored by a system undergoing deformation. Disuse and immobilization influence muscle fibres harmfully including decreased muscle strength and neural activation of muscle fibre, muscle atrophy, loss of force production and endurance due to decrease in cross-sectional area (CSA). Jones et al., found that immobilization leads to muscle atrophy by decreasing protein synthesis and increasing protein impairment and loss of muscle mass after two weeks of immobilization. Muscle atrophy can exist in the following injury, during an illness such as cancer, sepsis and long term hospitalization. Shortening of myosin and actin filaments alters mechanical properties of muscle because of length-dependent force production. Moreover, the energy production of skeletal muscles is affected during the disuse period by decreasing fat oxidation and enhancing glycolysis, which is a source of muscle energy. Furthermore, muscle composition is impacted due to disuse and inactivity, mainly in type 1 fibre, which maintains postural control. Since radiotherapy and surgery impact negatively on muscle. For instance, after neck dissection, trapezius muscle atrophy seems to be due to SAN injury. It is found that atrophied trapezius muscle's stiffness was significantly lower because of physiological and intrinsic alterations associated with fatty infiltration and atrophy of muscle It is known that physical training affects muscle architecture, such as fibre type distribution, fascicle length, pennation angle and CSA, and force production. Since physical activity contributes to improving the CSA of skeletal muscle, muscle strength and bulk are increased. Moreover, exercise contributes to increased neural activity, contractile tissue and differentiating fibre type. Muscle mechanical properties may change. Myofascial techniques are one of the manual therapy interventions which focus on treating fascia. It comprises various techniques and interventions such as acupuncture, dry needling, wet needling with pharmaceuticals, and traditional technical approaches such as strain-counter strain, muscle energy technique, positional release, ischemic compression and myofascial release (MFRT). The effectiveness of MFRT has been shown in various trials in different fields. For instance, MFRTs improve outcomes in individuals having shoulder pain, ankle joint restriction, fibromyalgia and lateral epicondylitis. On the other hand, in the cancer field, since MFRTs perform in addition to a standard rehabilitation program, the effect mechanism of MFRT is unclear in cancer . However, it impacts positively on pain, emotions and cancer-related fatigue. As stated in the surgery part, inflammatory response leads to fibrosis due to increasing edema and healing proteins. This chronic tension that results in abuse, disuse, overuse and anxiety could cause fascial thickening. Within this regard, fascial work is one of the most important parts for treating fibrosis. As mentioned before, patients with head and neck cancer suffer from the side effects of the treatment. One of the harmful effects of the treatments mostly causes neck and shoulder muscle atrophy, fibrosis and reduction in functionality level. Therefore, it is important to determine changes in mechanical properties of muscles so as to understand effectiveness of physical therapy interventions in HNC patients. To our knowledge, this study will be the first study to directly investigate how neck and shoulder muscles adapt to physical therapy interventions in the scope of material behaviour in HNC patients after neck dissection. This study will be conducted in Yeditepe University Research Hospital/ Ear Nose and Throat Department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Spinal Accessory Nerve Injury, Thyroid Cancer, Scapular Dyskinesis, Cervical Pain, Shoulder Pain
Keywords
Head and Neck Cancer, Shear Wave Elastography, Myofascial Release, Cancer Rehabilitation, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized single blind controlled clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive usual care ( standard physical therapy program)
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Particiapnts in intervevention group will receive both usual care and myofascial release techniques
Intervention Type
Other
Intervention Name(s)
Myofascial Release Technique
Intervention Description
Sternocleidomastoid, Upper trapezius, Suboccipital region, Scalenes, Pectoral release, Scapular and hyoid mobilization techniques. Duration: 6 weeks, 1 supervised session per week, and the session lasted 30 minutes.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Therapeutic exercise: passive and active range of motion, strengthening and postural exercise in order to improve shoulder and cervical mobility, muscle flexibility, strength and endurance, postural control and movement patterns; 2) stretching of pectoral muscles and serratus anterior; 3) scar tissue massage to reduce scar tissue's stiffness. Duration of the intervention: 6 weeks (1 supervised session and 2 individual per week). Each exercise will be done 1-3 sets and 5-10 repetitions.The session lasted 30 minutes. Exercise diary will be utilized in order to follow the exercise program.
Intervention Type
Other
Intervention Name(s)
Scar Tissue Massage
Intervention Description
Circular, Up and Down, Side to Side technique
Primary Outcome Measure Information:
Title
Shoulder pain and disability level
Description
Shoulder Pain and Disability Index
Time Frame
Change from baseline at 6 weeks
Title
Muscle Stiffness
Description
It will be measured by Shear Wave Elastography in relax and contracted state of muscle Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral
Time Frame
Change from baseline at 6 weeks
Title
Muscle Thickness
Description
It will be measured by Shear Wave Elastography Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral
Time Frame
Change from baseline at 6 weeks
Title
The Quality of Life
Description
The Functional Assessment of Chronic Illness Therapy system of Quality of Life- Head and Neck (FACT H&N Turkish Version)
Time Frame
Change from baseline at 6 weeks
Title
Shoulder Abduction
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Shoulder Flexion
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Shoulder Internal Rotation
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Shoulder External Rotation
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Neck Rotation
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Neck Flexion
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Neck Extension
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Title
Neck Lateral Flexion
Description
Active range of motion will be measured by goniometer for both side
Time Frame
Change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Mandibular depression
Description
Gap between two incisor teeth with full opened mouth
Time Frame
Change from baseline at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18-year-old Having modified or functional neck dissection 60< Karnofsky Score Spinal accesory nerve injury symptoms, such as dropped and winged scapula and decreased shoulder abduction in physical examination. Exclusion Criteria: Metastasis Having Radiotherapy- Chemoradiotherapy Having severe psychological problem Having previous shoulder injury/ scapular dyskinesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ferhat SIMSEK, PhD(c)
Phone
+905330258894
Email
pt.simsek@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali F OKYAR, Dr.
Phone
+905335577227
Email
okyar@yeditepe.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali F OKYAR, Dr.
Organizational Affiliation
Yeditepe University
Official's Role
Study Director
Facility Information:
Facility Name
Yeditepe University Hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferhat SIMSEK, MSc
Phone
+905330258894
Email
pt.simsek@gmail.com
First Name & Middle Initial & Last Name & Degree
Ali Fethi OKYAR, PhD
Phone
+905335577227
Email
fethio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
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Investigation of Effects of Physiotherapy Interventions on Mechanical Properties of Muscle in Head and Neck Cancer

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