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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06397742
Other study ID # PHYSIOACCESS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source The Greater Poland Cancer Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical activity
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 techniques
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.

Locations

Country Name City State
Poland Ewa Tanska Poznan Polska

Sponsors (1)

Lead Sponsor Collaborator
The Greater Poland Cancer Centre

Country where clinical trial is conducted

Poland, 

References & Publications (15)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Cervical spine range of motion: cervical flexion, measured in degrees Cervical spine range of motion: cervical flexion, measured in degrees within one week pre-intervention and one week after the intervention
Secondary Cervical spine range of motion: cervical extension, measured in degrees Cervical spine range of motion: cervical extension, measured in degrees within one week pre-intervention and one week after the intervention
Secondary Cervical spine range of motion: cervical lateral flexion, measured in centimetres Cervical spine range of motion: cervical lateral flexion, measured in centimetres within one week pre-intervention and one week after the intervention
Secondary Cervical spine range of motion: cervical rotation, measured in centimetres Cervical spine range of motion: cervical rotation, measured in centimetres within one week pre-intervention and one week after the intervention
Secondary Passive skeletal muscle tone Passive skeletal muscle tone in the upper trapezius on both sides, measured by surface electromyography (sEMG) amplitude within one week pre-intervention and one week after the intervention
Secondary Skeletal muscle tone Skeletal muscle tone in the upper trapezius on both sides, measured at one second of muscle activation using sEMG amplitude within one week pre-intervention and one week after the intervention
Secondary 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 within one week pre-intervention and one week after the intervention
Secondary 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 within one week pre-intervention and one week after the intervention
Secondary 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 within one week pre-intervention and one week after the intervention
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