Effectiveness of Self-Physiotherapy in the Management of Lymphedema

NCT06652295 | Enrolling By Invitation

• 1 other identifier: DEU-FTR-SCG-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Lymphedema; Self Care; Quality of Healthcare; Self Management

Keywords

Breast cancer; Upper extremity lymphedema; Complex Decongestive Physiotherapy; Self Management; Health-Related Quality of Life

Outcome Measures

Primary Outcomes (2)

• Edema severity

  The severity of lymphedema was evaluated by circumferential measurement. The circumference of both limbs was measured starting from the nail base of the third finger to the proximal part at 5 cm intervals. The difference between both arms was recorded in cm. The severity of edema was evaluated according to the criteria determined by the American Physical Therapy Association. According to these criteria, a difference of less than 3 cm between both limbs was recorded as mild severity, 3-5 cm as moderate severity, and greater than 5 cm as severe lymphedema.

  Change from oedema severity baseline at 3 weeks (end of treatment) to 3 months (follow-up sessions)

• Symptom Assessment

  A numerical scale from 0 to 10 was used for symptom assessment (severity of pain, swelling, feeling of heaviness, increased temperature, feeling of tightness, fatigue, numbness and tingling). A numerical scale from 0 to 10 was used to report severity. 0 indicates no complaints; 10 indicates intolerable complaints.

  Change from baseline symptoms at 3 weeks (end of treatment) to 1 month and 3 months (follow-up sessions)

Secondary Outcomes (7)

• Range of Motion

  Change from baseline upper extremity range of motion at 3 weeks (end of treatment)

• Hand grip strength

  Change from baseline hand grip strength at 3 weeks (end of treatment)

• Assessment of Physical Activity Level

  Change from baseline physical activity level at 3 weeks (end of treatment)

• Patient Benefit Index

  Change from baseline patient benefit index score at 3 weeks (end of treatment)

• Health Related Quality of Life Assesment

  Change from baseline symptoms at 3 weeks (end of treatment)

Study Arms (2)

Intervention/Treatment

ACTIVE COMPARATOR

This group was enrolled in a complex decongestive physiotherapy programme administered by a physiotherapist five days a week for three weeks.

Other: Complex decongestive physiotherapy (CDP)

Self-administered Group

OTHER

This group was enrolled in a self-administered complex decongestive physiotherapy programme five days a week for three weeks.

Other: Self-administered Complex Decongestive Physiotherapy (CDP)

Interventions

Complex decongestive physiotherapy (CDP) OTHER

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.

Intervention/Treatment

Self-administered Complex Decongestive Physiotherapy (CDP) OTHER

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.

Self-administered Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, 35210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor who is unaware of the group of participants going to perform all evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 22, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: January 25, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)