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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05399953
• Other study ID #: YeditepeU-Biotechnology
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: January 2023
• Source: Yeditepe University
• Contact: Ferhat SIMSEK, PhD(c)
• Phone: +905330258894
• Email: pt.simsek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: November 1, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accessory Nerve Injuries
• Cervical Pain
• Head and Neck Cancer
• Head and Neck Neoplasms
• Neck Pain
• Scapular Dyskinesis
• Shoulder Pain
• Spinal Accessory Nerve Injury
• Thyroid Cancer

Intervention

Other:
• Myofascial Release Technique
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.
• Exercise
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.
• Scar Tissue Massage
Circular, Up and Down, Side to Side technique

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Yeditepe University	Yeditepe University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

Carvalho AP, Vital FM, Soares BG. Exercise interventions for shoulder dysfunction in patients treated for head and neck cancer. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD008693. doi: 10.1002/14651858.CD008693.pub2. — View Citation

Chen YH, Lin CR, Liang WA, Huang CY. Motor control integrated into muscle strengthening exercises has more effects on scapular muscle activities and joint range of motion before initiation of radiotherapy in oral cancer survivors with neck dissection: A randomized controlled trial. PLoS One. 2020 Aug 6;15(8):e0237133. doi: 10.1371/journal.pone.0237133. eCollection 2020. — View Citation

De Groef A, Van Kampen M, Vervloesem N, Dieltjens E, Christiaens MR, Neven P, Vos L, De Vrieze T, Geraerts I, Devoogdt N. Effect of myofascial techniques for treatment of persistent arm pain after breast cancer treatment: randomized controlled trial. Clin Rehabil. 2018 Apr;32(4):451-461. doi: 10.1177/0269215517730863. Epub 2017 Sep 15. — View Citation

Eickmeyer SM, Walczak CK, Myers KB, Lindstrom DR, Layde P, Campbell BH. Quality of life, shoulder range of motion, and spinal accessory nerve status in 5-year survivors of head and neck cancer. PM R. 2014 Dec;6(12):1073-80. doi: 10.1016/j.pmrj.2014.05.015. Epub 2014 May 28. — View Citation

Gane EM, Michaleff ZA, Cottrell MA, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. Prevalence, incidence, and risk factors for shoulder and neck dysfunction after neck dissection: A systematic review. Eur J Surg Oncol. 2017 Jul;43(7):1199-1218. doi: 10.1016/j.ejso.2016.10.026. Epub 2016 Nov 17. — View Citation

Huang YC, Lee YY, Tso HH, Chen PC, Chen YC, Chien CY, Chung YJ, Leong CP. The Sonography and Physical Findings on Shoulder after Selective Neck Dissection in Patients with Head and Neck Cancer: A Pilot Study. Biomed Res Int. 2019 Jul 22;2019:2528492. doi: 10.1155/2019/2528492. eCollection 2019. — View Citation

Huang YP, Zheng YP, Leung SF. Quasi-linear viscoelastic properties of fibrotic neck tissues obtained from ultrasound indentation tests in vivo. Clin Biomech (Bristol, Avon). 2005 Feb;20(2):145-54. doi: 10.1016/j.clinbiomech.2004.09.012. — View Citation

Liu KH, Bhatia K, Chu W, He LT, Leung SF, Ahuja AT. Shear Wave Elastography--A New Quantitative Assessment of Post-Irradiation Neck Fibrosis. Ultraschall Med. 2015 Aug;36(4):348-54. doi: 10.1055/s-0034-1366364. Epub 2014 Aug 29. — View Citation

McGarvey AC, Hoffman GR, Osmotherly PG, Chiarelli PE. Maximizing shoulder function after accessory nerve injury and neck dissection surgery: A multicenter randomized controlled trial. Head Neck. 2015 Jul;37(7):1022-31. doi: 10.1002/hed.23712. Epub 2014 Jul 11. — View Citation

McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, Courneya KS. Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivors: a randomized controlled trial. Cancer. 2008 Jul 1;113(1):214-22. doi: 10.1002/cncr.23536. — View Citation

McNeely ML, Parliament MB, Seikaly H, Jha N, Magee DJ, Haykowsky MJ, Courneya KS. Predictors of adherence to an exercise program for shoulder pain and dysfunction in head and neck cancer survivors. Support Care Cancer. 2012 Mar;20(3):515-22. doi: 10.1007/s00520-011-1112-1. Epub 2011 Feb 24. — View Citation

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain and disability level	Shoulder Pain and Disability Index	Change from baseline at 6 weeks
Primary	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	Change from baseline at 6 weeks
Primary	Muscle Thickness	It will be measured by Shear Wave Elastography Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral	Change from baseline at 6 weeks
Primary	The Quality of Life	The Functional Assessment of Chronic Illness Therapy system of Quality of Life- Head and Neck (FACT H&N Turkish Version)	Change from baseline at 6 weeks
Primary	Shoulder Abduction	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Shoulder Flexion	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Shoulder Internal Rotation	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Shoulder External Rotation	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Neck Rotation	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Neck Flexion	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Neck Extension	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Primary	Neck Lateral Flexion	Active range of motion will be measured by goniometer for both side	Change from baseline at 6 weeks
Secondary	Mandibular depression	Gap between two incisor teeth with full opened mouth	Change from baseline at 6 weeks