Accessory Nerve InjuriesPHYSIOACCESSNCT06397742
Assessing the Implementation of Myofascial Techniques in Patients With Accessory Nerve Damage After Oncologic Treatment
A study testing Physical activity and Physical therapy - myofascial techniques in people with Accessory Nerve Injuries and Physical Therapy, run by The Greater Poland Cancer Centre at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Accessory Nerve Injuries, Physical Therapy
- What is being tested?
- Physical activity and Physical therapy - myofascial techniques
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Implementation of Myofascial Techniques in Patients With Symptoms of Accessory Nerve Damage After Oncologic Treatment in the Head and Neck Regions
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.
Read more
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.
Read the detailed description
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. However, depending on the cancer stage, in numerous cases it is possible to successfully save bodily structures and maintain continuation of nerves.
The analysis of complications shows that about 80% of patients communicate subjective discomforts of upper limb on the side of the surgery. After surgery treatment including lymphadenectomy (lymph node dissection) in the head and neck area, 60% of patients suffer from the damage or dysfunction of the accessory nerve.
As a consequence, there are numerous symptoms limiting the normal functioning of a patient. Among the most frequent symptoms of accessory nerve damage is a muscle dysfunction on the side of the nerve damage (trapezius muscle, sternocleidomastoid muscle). As a result of the accessory nerve damage, patients develop disability due to limitations to the head flexion, extension, and rotation, asymmetric shoulder blades, disturbed shoulder joint abduction, flexion, and external rotation (supination). Additionally, patients 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, endurance of the impairment is often related to patients' limited access to an effective therapy
Purpose of the research:
The aim of this study is 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 dysfunction after surgical head and neck cancer treatment. The study will include patients treated surgically for head and neck cancer with one-sided lymphadenectomy in the head and neck region who present with pain, restricted mobility or muscle atrophy. Recruited patients will be divided into one of two groups: the first group will receive physical therapy including myofascial techniques performed by the physical therapist three times a week for 45 minutes, and the second group will receive a specially designed set of exercises to perform at home three times a week for 45 minutes. The intervention will last six weeks and patients will be assessed before and after intervention. Patient's neuromuscular condition will be examined using surface electromyography (sEMG), pain at rest, during shoulder flexion, and on trapezius muscle palpation will be measured using Visual Analogue Scale, and quality of life will be assessed using modified Neck Dissection Impairment Index (NDII) questionnaire.
Specific aims:
- To create an algorithm of physiotherapeutic procedures in case of the dysfunction of the accessory nerve and related complications.
- To assess the effect of applied techniques on the mobility of the cervical section of the spine.
- To assess the influence of the therapy on the mobility of the shoulder girdle on the post-surgery side.
- To assess the influence of the therapy on patients' pain related discomfort.
- To assess the feasibility of applying sEMG (surface electromyography) to verify the efficiency of the therapy.
- Conditions
- Accessory Nerve Injuries, Physical Therapy
- Being tested
- Physical activity, Physical therapy - myofascial techniques
- Keywords
- head and neck cancer, nerve dysfunction, physical therapy
- Medical subject headings
- Accessory Nerve Injuries, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
Also called Home exercise program
Patients received a set of exercises to execute at home. The home exercise program comprised 12 exercises conducted in sequence:
- Symmetrical shoulder raises with retraction
- Rolling upper extremities using a ball
- Symmetrical shoulder raises
- Band exercises strengthening the upper girdle and arm
- Exercise of the shoulder joint flexors
- Side arm raises in supine position
- Lateral arm raises in supine position
- Head raises with rotation in supine position
- Side arm raises in prone position
- Front arm raises in prone position
- Rising and lowering the upper girdle in prone position
- Neck muscles stretches
Physical therapy - myofascial techniquesOther
Also called Physical therapy program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder range of motion: flexion, measured in degrees
Shoulder range of motion: flexion, measured in degrees
Measured: 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
Measured: 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
Measured: 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
Measured: within one week pre-intervention and one week after the intervention
Secondary outcomes (9)
Cervical spine range of motion: cervical flexion, measured in degrees
Cervical spine range of motion: cervical flexion, measured in degrees
Measured: within one week pre-intervention and one week after the intervention
Cervical spine range of motion: cervical extension, measured in degrees
Cervical spine range of motion: cervical extension, measured in degrees
Measured: within one week pre-intervention and one week after the intervention
Cervical spine range of motion: cervical lateral flexion, measured in centimetres
Cervical spine range of motion: cervical lateral flexion, measured in centimetres
Measured: within one week pre-intervention and one week after the intervention
Cervical spine range of motion: cervical rotation, measured in centimetres
Cervical spine range of motion: cervical rotation, measured in centimetres
Measured: within one week pre-intervention and one week after the intervention
Passive skeletal muscle tone
Passive skeletal muscle tone in the upper trapezius on both sides, measured by surface electromyography (sEMG) amplitude
Measured: within one week pre-intervention and one week after the intervention
Skeletal muscle tone
Skeletal muscle tone in the upper trapezius on both sides, measured at one second of muscle activation using sEMG amplitude
Measured: within one week pre-intervention and one week after the intervention
Skeletal muscle fatigue
Skeletal muscle fatigue in the upper trapezius on both sides, measured as the difference between sEMG amplitude at one second and at the last second of muscle activation
Measured: within one week pre-intervention and one week after the intervention
Assessment of pain symptoms using Visual Analogue Scale (VAS) measured at rest, during shoulder flexion, and during trapezius muscle palpation; a single scale questionnaire, with range of points 1-10, with higher score meaning more intense pain
Assessment of pain symptoms using Visual Analogue Scale (VAS) measured at rest, during shoulder flexion, and during trapezius muscle palpation; a single scale questionnaire, with range of points 1-10, with higher score meaning more intense pain
Measured: within one week pre-intervention and one week after the intervention
Quality of life after neck dissection, scored based on the Neck Dissection Impairment Index (NDII) questionnaire, a single scale with range of points 5-50, with a higher score meaning worse quality of life
Quality of life after neck dissection, scored based on the Neck Dissection Impairment Index (NDII) questionnaire, a single scale with range of points 5-50, with a higher score meaning worse quality of life
Measured: within one week pre-intervention and one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Accessory Nerve InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Greater Poland Cancer Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Górecki, PhD, Principal investigator, Greater Poland Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397742
- Sponsor's protocol ID
- PHYSIOACCESS
- Acronym
- PHYSIOACCESS
- Status last verified
- Mar 2020
- First submitted
- 15 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21154824Popovski 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.
PubMed 29165431Marszałek 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
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.
PubMed 23093823Goldstein 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.
PubMed 23554002Dijkstra 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.
PubMed 11754498Koybasioglu 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.
PubMed 16446553Carvalho 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.
PubMed 22513964Day 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.
PubMed 19329049Laska T, Hannig K. Physical therapy for spinal accessory nerve injury complicated by adhesive capsulitis. Phys Ther. 2001 Mar;81(3):936-44.
PubMed 11268158McGarvey 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.
PubMed 22864015McGarvey 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.
PubMed 25042422Hindle 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.
PubMed 23487249Gane 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.
PubMed 29770954Tarkan 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
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Implementation of Myofascial Techniques in Patients With Symptoms of Accessory Nerve Damage After Oncologic Treatment in the Head and Neck Regions
- ClinicalTrials.gov ID
- NCT06397742
- Acronym / sponsor ID
- PHYSIOACCESS / PHYSIOACCESS
- Conditions
- Accessory Nerve Injuries, Physical Therapy
- Keywords
- head and neck cancer, nerve dysfunction, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The Greater Poland Cancer CentreUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. However, depending on the cancer stage, in numerous cases it is possible to successfully save bodily structures and maintain continuation of nerves.
The analysis of complications shows that about 80% of patients communicate subjective discomforts of upper limb on the side of the surgery. After surgery treatment including lymphadenectomy (lymph node dissection) in the head and neck area, 60% of patients suffer from the damage or dysfunction of the accessory nerve.
As a consequence, there are numerous symptoms limiting the normal functioning of a patient. Among the most frequent symptoms of accessory nerve damage is a muscle dysfunction on the side of the nerve damage (trapezius muscle, sternocleidomastoid muscle). As a result of the accessory nerve damage, patients develop disability due to limitations to the head flexion, extension, and rotation, asymmetric shoulder blades, disturbed shoulder joint abduction, flexion, and external rotation (supination). Additionally, patients 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, endurance of the impairment is often related to patients' limited access to an effective therapy
Purpose of the research:
The aim of this study is 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 dysfunction after surgical head and neck cancer treatment. The study will include patients treated surgically for head and neck cancer with one-sided lymphadenectomy in the head and neck region who present with pain, restricted mobility or muscle atrophy. Recruited patients will be divided into one of two groups: the first group will receive physical therapy including myofascial techniques performed by the physical therapist three times a week for 45 minutes, and the second group will receive a specially designed set of exercises to perform at home three times a week for 45 minutes. The intervention will last six weeks and patients will be assessed before and after intervention. Patient's neuromuscular condition will be examined using surface electromyography (sEMG), pain at rest, during shoulder flexion, and on trapezius muscle palpation will be measured using Visual Analogue Scale, and quality of life will be assessed using modified Neck Dissection Impairment Index (NDII) questionnaire.
Specific aims:
- To create an algorithm of physiotherapeutic procedures in case of the dysfunction of the accessory nerve and related complications.
- To assess the effect of applied techniques on the mobility of the cervical section of the spine.
- To assess the influence of the therapy on the mobility of the shoulder girdle on the post-surgery side.
- To assess the influence of the therapy on patients' pain related discomfort.
- To assess the feasibility of applying sEMG (surface electromyography) to verify the efficiency of the therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physical activity under supervision | Experimental | Other: Physical therapy - myofascial techniquesThe subjects receive physical therapy three times a week for 45 minutes, during a six-week period under professional supervision. |
| Home exercise | Active comparator | Other: Physical activityThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityAlso: Home exercise programPatients 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 | Other | Home exercise |
| Physical therapy - myofascial techniquesAlso: Physical therapy programPhysical 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. | Other | Physical activity under supervision |
Primary outcome
Shoulder range of motion: flexion, measured in degrees
Time frame: within one week pre-intervention and one week after the intervention
Shoulder range of motion: flexion, measured in degrees
Shoulder range of motion: abduction, measured in degrees
Time frame: within one week pre-intervention and one week after the intervention
Shoulder range of motion: abduction, measured in degrees
Shoulder range of motion: extension, measured in degrees
Time frame: within one week pre-intervention and one week after the intervention
Shoulder range of motion: extension, measured in degrees
Shoulder range of motion: rotation, measured in degrees
Time frame: within one week pre-intervention and one week after the intervention
Shoulder range of motion: rotation, measured in degrees
9 secondary outcomes
Cervical spine range of motion: cervical flexion, measured in degrees
Time frame: within one week pre-intervention and one week after the intervention
Cervical spine range of motion: cervical extension, measured in degrees
Time frame: within one week pre-intervention and one week after the intervention
Cervical spine range of motion: cervical lateral flexion, measured in centimetres
Time frame: within one week pre-intervention and one week after the intervention
Cervical spine range of motion: cervical rotation, measured in centimetres
Time frame: within one week pre-intervention and one week after the intervention
Passive skeletal muscle tone
Time frame: within one week pre-intervention and one week after the intervention
Skeletal muscle tone
Time frame: within one week pre-intervention and one week after the intervention
Skeletal muscle fatigue
Time frame: within one week pre-intervention and one week after the intervention
Assessment of pain symptoms using Visual Analogue Scale (VAS) measured at rest, during shoulder flexion, and during trapezius muscle palpation; a single scale questionnaire, with range of points 1-10, with higher score meaning more intense pain
Time frame: within one week pre-intervention and one week after the intervention
Quality of life after neck dissection, scored based on the Neck Dissection Impairment Index (NDII) questionnaire, a single scale with range of points 5-50, with a higher score meaning worse quality of life
Time frame: within one week pre-intervention and one week after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 21154824Bhattacharyya N. The increasing workload in head and neck surgery: An epidemiologic analysis. Laryngoscope. 2011 Jan;121(1):111-5. doi: 10.1002/lary.21193.
- Background: PubMed 29165431Popovski 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.
- BackgroundMarszałek 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: PubMed 23093823Guru 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.
- Background: PubMed 23554002Goldstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Górecki, PhD principal investigator
Greater Poland Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and Physical therapy - myofascial techniques in people with Accessory Nerve Injuries and Physical Therapy, run by The Greater Poland Cancer Centre at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder range of motion: flexion, measured in degrees (time frame: within one week pre-intervention and one week after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06397742, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.