Assessing the Implementation of Myofascial Techniques in Patients With Accessory Nerve Damage After Oncologic Treatment

NCT06397742 | Completed

• 1 other identifier: PHYSIOACCESS
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Accessory Nerve Injuries; Physical Therapy

Keywords

head and neck cancer; nerve dysfunction; physical therapy

Outcome Measures

Primary Outcomes (4)

• Shoulder range of motion: flexion, measured in degrees

  Shoulder range of motion: flexion, measured in degrees

  within one week pre-intervention and one week after the intervention

• Shoulder range of motion: abduction, measured in degrees

  Shoulder range of motion: abduction, measured in degrees

  within one week pre-intervention and one week after the intervention

• Shoulder range of motion: extension, measured in degrees

  Shoulder range of motion: extension, measured in degrees

  within one week pre-intervention and one week after the intervention

• Shoulder range of motion: rotation, measured in degrees

  Shoulder range of motion: rotation, measured in degrees

  within one week pre-intervention and one week after the intervention

Secondary Outcomes (9)

• Cervical spine range of motion: cervical flexion, measured in degrees

  within one week pre-intervention and one week after the intervention

• Cervical spine range of motion: cervical extension, measured in degrees

  within one week pre-intervention and one week after the intervention

• Cervical spine range of motion: cervical lateral flexion, measured in centimetres

  within one week pre-intervention and one week after the intervention

• Cervical spine range of motion: cervical rotation, measured in centimetres

  within one week pre-intervention and one week after the intervention

• Passive skeletal muscle tone

  within one week pre-intervention and one week after the intervention

Study Arms (2)

Physical activity under supervision

EXPERIMENTAL

The subjects receive physical therapy three times a week for 45 minutes, during a six-week period under professional supervision.

Other: Physical therapy - myofascial techniques

Home exercise

ACTIVE COMPARATOR

The subjects receive a set of exercises and a recommendation to perform them at least three times a week for 45 minutes. To ensure compliance the subjects receive journals to record the performed exercises. Additionally subjects are contacted by phone to motivate them to exercise with adequate intensity. Furthermore the proper exercise technique is verified at periodic control visits.

Other: Physical activity

Interventions

Physical activity OTHER

Patients received a set of exercises to execute at home. The home exercise program comprised 12 exercises conducted in sequence: 1. Symmetrical shoulder raises with retraction 2. Rolling upper extremities using a ball 3. Symmetrical shoulder raises 4. Band exercises strengthening the upper girdle and arm 5. Exercise of the shoulder joint flexors 6. Side arm raises in supine position 7. Lateral arm raises in supine position 8. Head raises with rotation in supine position 9. Side arm raises in prone position 10. Front arm raises in prone position 11. Rising and lowering the upper girdle in prone position 12. Neck muscles stretches

Also known as: Home exercise program

Home exercise

Physical therapy - myofascial techniques OTHER

Physical therapy program comprised five parts. I. Fascial manipulation targeted three most active center of coordination - center of fusion points within head, neck, shoulder, shoulder blade, or chest - during each session, time depending on the patients' adaptability. II. Manual mobilization of the scar area with each training session including: active myofascial stretching; manual scar mobilization by stretching perpendicularly and in parallel with the scar; soft tissue mobilization by rolling and pulling the surface tissues; myofascial relaxation by breaking through restrictions. III. Relaxation of muscle contractures using post-isometric muscle relaxation of the scalene muscle, sternocleidomastoid muscle, and neck muscles - until the sessions provided no muscle elongation. IV. Neuromuscular stimulation with proprioceptive neuromuscular facilitation - included scapula movement patterns, dynamic reversal, stabilizing reversal, upper extremity movement patterns.

Also known as: Physical therapy program

Physical activity under supervision

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients treated surgically for head and neck cancer with one-sided lymphadenectomy in the head and neck region,
• symptoms of damage to the accessory nerve,
• Eastern Cooperative Oncology Group (ECOG) scale 0-2,

You may not qualify if:

• local recurrence,
• distant metastases,
• cardiorespiratory failure,
• pain symptoms exceeding patients adaptability,
• decline of the patient's level of functioning to 3-4 in ECOG scale.

Sponsors & Collaborators

• The Greater Poland Cancer Centre: lead

Study Sites (1)

Ewa Tanska

Poznan, Polska, 61-866, Poland

Location

Related Publications (15)

• Bhattacharyya N. The increasing workload in head and neck surgery: An epidemiologic analysis. Laryngoscope. 2011 Jan;121(1):111-5. doi: 10.1002/lary.21193.

  PMID: 21154824 BACKGROUND

• Popovski V, Benedetti A, Popovic-Monevska D, Grcev A, Stamatoski A, Zhivadinovik J. Spinal accessory nerve preservation in modified neck dissections: surgical and functional outcomes. Acta Otorhinolaryngol Ital. 2017 Oct;37(5):368-374. doi: 10.14639/0392-100X-844.

  PMID: 29165431 BACKGROUND

• Marszałek W.S., Majchrzycki M., Golusiński W.: Dysfunctions of the locomotor system. Physiotherapy in head and neck cancer. Poznan: Poznan University of Medical Sciences Publishing House, 2012, ISBN: 978-83-7597-161-3

  BACKGROUND

• Guru K, Manoor UK, Supe SS. A comprehensive review of head and neck cancer rehabilitation: physical therapy perspectives. Indian J Palliat Care. 2012 May;18(2):87-97. doi: 10.4103/0973-1075.100820.

  PMID: 23093823 BACKGROUND

• Goldstein DP, Ringash J, Bissada E, Jaquet Y, Irish J, Chepeha D, Davis AM. Scoping review of the literature on shoulder impairments and disability after neck dissection. Head Neck. 2014 Feb;36(2):299-308. doi: 10.1002/hed.23243. Epub 2013 Apr 1.

  PMID: 23554002 BACKGROUND

• Dijkstra PU, van Wilgen PC, Buijs RP, Brendeke W, de Goede CJ, Kerst A, Koolstra M, Marinus J, Schoppink EM, Stuiver MM, van de Velde CF, Roodenburg JL. Incidence of shoulder pain after neck dissection: a clinical explorative study for risk factors. Head Neck. 2001 Nov;23(11):947-53. doi: 10.1002/hed.1137.

  PMID: 11754498 BACKGROUND

• Koybasioglu A, Bora Tokcaer A, Inal E, Uslu S, Kocak T, Ural A. Accessory nerve function in lateral selective neck dissection with undissected level IIb. ORL J Otorhinolaryngol Relat Spec. 2006;68(2):88-92. doi: 10.1159/000091209. Epub 2006 Jan 27.

  PMID: 16446553 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

• Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24.

  PMID: 19329049 BACKGROUND

• Laska T, Hannig K. Physical therapy for spinal accessory nerve injury complicated by adhesive capsulitis. Phys Ther. 2001 Mar;81(3):936-44.

  PMID: 11268158 BACKGROUND

• McGarvey AC, Osmotherly PG, Hoffman GR, Chiarelli PE. Impact of neck dissection on scapular muscle function: a case-controlled electromyographic study. Arch Phys Med Rehabil. 2013 Jan;94(1):113-9. doi: 10.1016/j.apmr.2012.07.017. Epub 2012 Aug 1.

  PMID: 22864015 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

• Hindle KB, Whitcomb TJ, Briggs WO, Hong J. Proprioceptive Neuromuscular Facilitation (PNF): Its Mechanisms and Effects on Range of Motion and Muscular Function. J Hum Kinet. 2012 Mar;31:105-13. doi: 10.2478/v10078-012-0011-y. Epub 2012 Apr 3.

  PMID: 23487249 BACKGROUND

• Gane EM, McPhail SM, Hatton AL, Panizza BJ, O'Leary SP. The relationship between physical impairments, quality of life and disability of the neck and upper limb in patients following neck dissection. J Cancer Surviv. 2018 Oct;12(5):619-631. doi: 10.1007/s11764-018-0697-5. Epub 2018 May 16.

  PMID: 29770954 BACKGROUND

• Tarkan Ö., Tuncer Ü., Bozdemir H., Sarpel T., Özdemir S., Surmelioglu Ö.: Clinical and electrophysiological evaluation of shoulder functions in spinal accessory nerve-preserving neck dissection. Turk J Med Sci, 2012; 42(5): 852-860

  BACKGROUND

MeSH Terms

Conditions

Accessory Nerve Injuries; Head and Neck Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Accessory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maciej Górecki, PhD

  Greater Poland Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will recruit patients who underwent surgical therapy for head and neck cancer, with one-sided removal of lymph nodes, and who present symptoms of accessory nerve dysfunction. The group will be recruited from patients who underwent the surgical treatment in Greater Poland Cancer Centre. Outline of the two interventions will be presented to each patient, after which the patient will choose the preferred intervention. All patients from the study group were treated at the Head and Neck Surgery and Laryngological Oncology Clinic at the Poznań University of Medical Science. The study group comprised 9 women and 16 men with an average of 51.1 y.o., and the control group comprised 6 women and 17 men with an average of 50,8y.o.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 3, 2024
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: May 3, 2024

Record last verified: 2020-03

Locations

PL (1)