NCT04286698

Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment

To Investigate the Effectiveness of Two Different Physiotherapy Programs in Lymphedema Following Head and Neck Cancer Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Izmir Bakircay University · Academic / Other
• Sex: All
• Age: 22 Years – 73 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to determine the effects of complex decongestive physiotherapy (CDP) and home programs on internal/external lymphedema, staging, fibrosis, and three-dimensional (3D) surface scanning and volume evaluation in head and neck lymphedema. Twenty-one patients were randomly divided into three groups: CDP; home program including self manual lymph drainage (MLD) and exercises; and control. CDP included MLD drainage, compression, exercise, and skin care. Self-MLD and exercises were performed by home program group patients. Assessment methods were applied at baseline and 4 weeks later for all groups. MD. Anderson Cancer Center Head and Neck Lymphedema Protocol was implemented to evaluate head and neck external lymphedema, staging, and fibrosis. An Artec Eva 3D scanner and the Autodesk ReCap Photo Studio software were used to determine and calculate the volume of the head and neck region via 3D surface scanning. Head and neck external lymphedema and fibrosis assessment criteria were performed to evaluate visible soft tissue edema and the degree of stiffness. To assess internal lymphedema, Patterson's scale was applied using fiber-optic endoscopic imaging.

Detailed description

Head and neck cancer (HNC) have been seen in 13.3/100,000 males and 2.8/100,000 in females in Turkey. HNC related treatments such as lymph node dissection, tumor excision, chemotherapy, radiotherapy, and cancer itself can cause head and neck lymphedema (HNL). The incidence of HNL due to HNC treatments (surgery, chemotherapy and chemoradiation) has been reported to be between 48% and 90%. A recognition of HNL has been growing in recent years, but HNL is still much less recognized than upper and lower limb lymphedema and is easily ignored by both patients and health care providers. Therefore, in many cases, the diagnosis and treatment of HNL may be delayed, or patients cannot access treatment. In routine practice, after HNC, the self-absorption of HNL is generally expected. Clinical experiences have confirmed that HNL develops 2-6 months after cancer treatment and regresses in some patients over time. A variety of physiotherapy approaches have been shown to prevent and minimize physical, functional, emotional, and social disorders resulting from HNL. However, complex decongestive physiotherapy (CDP) is considered a gold standard treatment method for lymphedema. This method consists of manual lymph drainage (MLD), skin care, compression therapy, and therapeutic exercises. Although there are many studies about the effects of CDP on upper and lower limbs, there is only a limited number of studies about HNL and CDP in the literature.

Conditions

• Head and Neck Cancer
• Lymphedema of Face
• Fibrosis; Skin

Interventions

Type	Name	Description
OTHER	Complex decongestive physiotherapy	MLD was administered 5 days a week for 4 weeks, with each session lasting 30 minutes \[25\]. Compression therapy was applied to the patients by wearing a compression mask (FM Velcro Fastener, LIPOELASTIC), made of polyamide, cotton, viscose, and elastane, that covered the submandibular region, the masseter region, and the neck. The compression mask is specifically designed for the healing and recovery of tissues after plastic and aesthetic surgeries. The patients were advised to wear the compression masks for at least 4-6 hours per day for 4 weeks and gradually increase wearing time according to their tolerance. The patients were asked to perform skin care by themselves. Skin care was applied using a low pH skin lotion to moisturize the skin. Neck, face/mimic, tongue, and posture exercises were performed by patients while the compression mask was worn and under the supervision of a physiotherapist, with 10 repetitions 5 times a week for 4 weeks.
OTHER	Home program	Self-MLD and exercises (neck, face/mimic, tongue, and posture exercises) were shown to the patients in this group. Self-MLD included self-administered lymph drainage of the axillary, posterior, lateral, and anterior neck areas; the pre- and retro-auricular regions; the lateral and anterior regions of the face; and the lower jaw region. Then the order is reversed back to the starting point \[3\]. A video of self-MLD and a text including exercise descriptions were shared with patients and their relatives to ensure that the self-MLD and exercises were performed accurately and regularly at home. Self-MLD was recommended to be applied once a day, and the exercises were advised to be performed for 10 repetitions each, 10 times a day for 4 weeks. The patients were called by phone during the second week after their first evaluation as a control and to motivate the patient for performing self-MLD and home exercises properly.

Timeline

• Start date: 2018-03-05
• Primary completion: 2019-02-15
• Completion: 2019-03-15
• First posted: 2020-02-27
• Last updated: 2020-02-27

Locations

1 site across 1 country: Turkey (Türkiye)