The Effect of Complex Decongestive Therapy in Patients With Lymphedema

NCT ID: NCT06220903

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-06-30

Brief Summary

The aim of this study is to investigate objectively the effect of lymphatic fluid which is circulated with Complex Decongestive Therapy on fluid excretion from the body in patients with lymphedema.

Detailed Description

The lymphatic system is the accessory circulatory system that takes lymph fluid from the interstitial space and adds it to the blood circulation. It starts from the interstitial space. It consists of lymph vessels, lymph fluid and lymphatic organs. Lymph fluid passes through many lymph nodes during its transport and is filtered in these nodules. The lymphatic system takes lymphatic fluid from the tissues and brings it to the venous part of the circulatory system. The main task of the lymph system is to reabsorb substances that cannot be absorbed by the blood circulation system. Non-absorbable substances in the interstitial space are called lymphatic load. Lymphatic load; It consists of protein, water, fat and cells. The aim of lymphedema treatment is to remove the protein-rich fluid accumulated in the interstitial space into the venous system. There are many factors in the flow of lymph fluid into the veins. The most important of these is the high filtration pressure that occurs when fluid is filtered through blood capillaries. Lymph fluid flowing from the periphery to the center is generally affected by pressure changes and moves from where the pressure is high to where it is low. Contraction of the muscles adjacent to the lymph vessels, pulsation of the neighboring arteries, and the effect of the smooth muscles in the lymph vessel wall also cause pressure changes. Other factors include respiratory movements acting as a pump in the lymph flow, the actual pressure effect of abdominal pressure on the cisterna chyli, and negative intrathoracic pressure.

Complex Decongestive Physiotherapy is proven effective and considered the gold standard for the treatment of lymphedema. It increases the hydrostatic pressure that has decreased due to edema and helps the lymph fluid to re-enter the circulation.

Purpose of the study; To objectively investigate whether the lymph fluid added to the circulation through Complex Decongestive Physiotherapy in lymphedema patients has an effect on fluid excretion from the body.

Conditions

Lymphedema; Urine Marking; Quality of Life; Edema

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

Complex DecongestivePhysiotherapy program was planned for the affected extremity of the cases. The treatment was performed 5 days a week, for 4 weeks, for a total of 20 sessions and each session was 60 minutes. The treatment included Manual Lymph Drainage, skin care, multi-layer bandaging, exercise and compression stockings.

Group Type: EXPERIMENTAL

Complex Decongestive Therapy

Intervention Type: OTHER

1. Manual Lymph Drainage: Cervical region lymph drainage and abdominal region lymph drainage (especially combined with abdominal breathing) were applied.

2. Skin Care: Moisturizing creams with a pH of 5.5 were applied to the extremities before bandaging.

3. Multilayer Bandaging: Short pull bandage application was applied in a gradient manner.

4. Exercise: Joint range of motion exercises, breathing exercises (abdominal breathing), decongestive exercises, and self-drainage techniques were taught.

5. Compression Stocking: After the decongestion phase was over, flat knit compression stockings were recommended according to the patient's extremity.

Interventions

Complex Decongestive Therapy

1. Manual Lymph Drainage: Cervical region lymph drainage and abdominal region lymph drainage (especially combined with abdominal breathing) were applied.

2. Skin Care: Moisturizing creams with a pH of 5.5 were applied to the extremities before bandaging.

3. Multilayer Bandaging: Short pull bandage application was applied in a gradient manner.

4. Exercise: Joint range of motion exercises, breathing exercises (abdominal breathing), decongestive exercises, and self-drainage techniques were taught.

5. Compression Stocking: After the decongestion phase was over, flat knit compression stockings were recommended according to the patient's extremity.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female cases
• Cases diagnosed with lower extremity unilateral/bilateral lymphedema
• Having received or not received radiotherapy and/or chemotherapy

Exclusion Criteria

• Having received treatment for lymphedema in the last year
• Having metastatic disease
• Those diagnosed with severe heart failure and/or arrhythmia
• Arterial disorders
• Kidney diseases
• Infection in affected extremities
• Psychological disorders
• Diabetes
• Nephrotic syndrome
• Diuretic use
• Patients using chemotherapy and drugs that have toxic effects on the kidneys
• Those with liver cirrhosis, liver disease
• Neurological diseases

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Dilanur Özkaraoğlu, PT, MSc

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cemile Uydur, MsC

Role: PRINCIPAL_INVESTIGATOR

Avrupa Şafak Hospital Physical Therapy and Rehabilitation Unit

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MedipolU-FTR-DO-02

Identifier Type: -

Identifier Source: org_study_id