Clinical trial NCT05399953: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Yeditepe University
Sponsor class: OTHER
Collaborators: name: Yeditepe University Hospital
First posted: 2022-06-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized single blind controlled clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Shoulder pain and disability level
timeFrame: Change from baseline at 6 weeks
measure: Muscle Stiffness
timeFrame: Change from baseline at 6 weeks
measure: Muscle Thickness
timeFrame: Change from baseline at 6 weeks
measure: The Quality of Life
timeFrame: Change from baseline at 6 weeks
measure: Shoulder Abduction
timeFrame: Change from baseline at 6 weeks
measure: Shoulder Flexion
timeFrame: Change from baseline at 6 weeks
measure: Shoulder External Rotation
timeFrame: Change from baseline at 6 weeks
measure: Neck Rotation
timeFrame: Change from baseline at 6 weeks
measure: Neck Flexion
timeFrame: Change from baseline at 6 weeks
measure: Neck Extension
timeFrame: Change from baseline at 6 weeks
measure: Neck Lateral Flexion
timeFrame: Change from baseline at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University Hospital
Study officials:
affiliation: Yeditepe University
name: Ali F OKYAR, Dr.
role: STUDY_DIRECTOR
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