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Clinical Trials in Turkey / NCT06652295
Enrolling by invitation Not applicable

Effectiveness of Self-Physiotherapy in the Management of Lymphedema

NCT06652295 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-01-01
Last updated
2024-12-04

Condition(s) studied

Breast CancerLymphedemaSelf CareQuality of HealthcareSelf Management

Investigational drug(s) / intervention(s)

Complex decongestive physiotherapy (CDP)Self-administered Complex Decongestive Physiotherapy (CDP)

Complex decongestive physiotherapy (CDP): CDP consists of patient education, manual lymph drainage, short traction bandaging, skin/nail care and exercise. The applications of all modalities of the CDP programme were performed by the physiotherapist.

Self-administered Complex Decongestive Physiotherapy (CDP): The self-administered CDP programme consisted of patient education, self-manual lymph drainage, self-short traction bandage application, self-skin/nail care and exercise. Participants were given one session of patient education before the self-administered CDP programme and patients were given practical information about all applications. Additionally, each component of the self-administered CDP programme was presented to the participants with a patient booklet and a video prepared by the researchers. Patients in the self-CDP group were followed up once a week with a patient follow-up diary.

Study summary

Breast cancer-related lymphedema is a chronic condition adversely affecting physical, social, psychological and emotional well-being. The complex decongestive physiotherapy (CDP) programme is considered the gold standard in the management of lymphedema. The most important barriers affecting patient participation in the CDP programme are the lack of trained health personnel and the difficulty for patients to access treatment (peripheral location or financial difficulties). Therefore, self-administration of the CDP programme may contribute to the development of self-care strategies and the reduction of treatment costs.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
* Being 18 years of age or older * Having stage 1-3 lymphedema according to the International Society of Lymphology (ISL) classification * Having a diagnosis of unilateral breast cancer-related lymphedema (Doppler, lymphoscintigraphy, and computed tomography were preferred to confirm the diagnosis of lymphedema based on a comprehensive medical assessment and condition of the patient) * No evidence/suspicion of cancer recurrence after completion of adjuvant local and systemic therapies for at least 12 months * Not having received a complex decongestive physiotherapy programme in the last 6 months * Volunteer to participate in the study Able to read and understand Turkish. Exclusion Criteria: * Inability to understand the questionnaires and refusal to participate * History of congenital lymphedema or bilateral upper extremity lymphedema or malignant lymphedema * Presence of neurological or mental illness or axillary web syndrome, major organ failure, or/ iatrogenic disease that may adversely affect the severity of lymphedema (such as using steroids, nonsteroidal anti-inflammatory drugs, and calcium channel blockers) * Presence of conditions contraindicated for complex decongestive physiotherapy (active infection, deep vein thrombosis/thrombophlebitis, cardiac oedema, pulmonary disease, peripheral arterial disease, any skin disease such as scleroderma, allergic reactions to treatment).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Dokuz Eylul University Izmir Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06652295 on ClinicalTrials.gov ↗ ← All trials in Turkey