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

NCT05399953 | Completed

• 1 other identifier: YeditepeU-Biotechnology
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (11)

• Shoulder pain and disability level

  Shoulder Pain and Disability Index

  Change from baseline at 6 weeks

• Muscle Stiffness

  It will be measured by Shear Wave Elastography in relax and contracted state of muscle Muscles: M. Upper Trapezius, M. Sternocleidomastoid

  Change from baseline at 6 weeks

• Muscle Thickness

  It will be measured by USG B-mode Muscles: M. Upper Trapezius, M. Sternocleidomastoid, M. Masseter /Bilateral

  Change from baseline at 6 weeks

• 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

• Shoulder Abduction

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

• Shoulder Flexion

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

• Shoulder External Rotation

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

• Neck Rotation

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

• Neck Flexion

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

• Neck Extension

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

• Neck Lateral Flexion

  Active range of motion will be measured by goniometer for both side

  Change from baseline at 6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Exercise; Other: Scar Tissue Massage

Intervention Group

EXPERIMENTAL

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

Other: Myofascial Release Technique; Other: Exercise; Other: Scar Tissue Massage

Interventions

Myofascial Release Technique OTHER

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 Group

Exercise OTHER

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.

Control Group; Intervention Group

Scar Tissue Massage OTHER

Circular, Up and Down, Side to Side technique

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yeditepe University: lead
• Yeditepe University Hospital: collaborator

Study Sites (1)

Yeditepe University Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 31912902 BACKGROUND

• 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.

  PMID: 32760097 BACKGROUND

• 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;2012(4):CD008693. doi: 10.1002/14651858.CD008693.pub2.

  PMID: 22513964 BACKGROUND

• 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.

  PMID: 28914087 BACKGROUND

• 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.

  PMID: 24880060 BACKGROUND

• 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.

  PMID: 27956321 BACKGROUND

• 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.

  PMID: 31428629 BACKGROUND

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

  PMID: 15621318 BACKGROUND

• 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.

  PMID: 25171602 BACKGROUND

• 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.

  PMID: 25042422 BACKGROUND

• 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.

  PMID: 18457329 BACKGROUND

• 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.

  PMID: 21347523 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Accessory Nerve Injuries; Thyroid Neoplasms; Neck Pain; Shoulder Pain

Interventions

Myofascial Release Therapy; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Accessory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ali F OKYAR, Dr.

  Yeditepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Model Details: A randomized single blind controlled clinical trial

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: November 10, 2022
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)