Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema

Lower Extremity Lymphedema Clinical Trial

Official title:

Comparison of Efficacy of Platelets / Platelet Enriched Plasma Regard (PRP) Method, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080207
• Other study ID #: TSA-2017-22398
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2019
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

At the end of the study, comparative information about the effects of PRP, complex decongestive physiotherapy and low level laser on edema volume, range of motion, muscle strength, functional capacity and quality of life will be obtained in the treatment of patients with lower limb lymphedema.

Since there is no study about this field in the literature, this study will provide new and valuable contributions about treatment of lower extremity lymphedema for the researchers and clinicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 1, 2018
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Having lower extremity lymphedema

• To be older than 18 ages.

Exclusion Criteria:

• Having received radiotherapy treatment in the last 6 months,

• Having received physiotherapy treatment in the last 6 months,

• General health status is not eligible for treatment

Related Conditions & MeSH terms

• Lower Extremity Lymphedema
• Lymphedema

Intervention

Procedure:
• PRP method
It will first be placed on a 25 cc venous blood centrifuge in anticoagulated tubes containing acid citrate dextrose (ACD), and autologous venous blood will be centrifuged at 3200 rpm for 15 minutes. Using the PRP kit, the plasma rich in platelet volume of about 3 cc volume will be removed. This will be activated by the addition of platelet agonists such as thrombin, calcium gluconate or calcium chloride. Injections should be administered subcutaneously for 2-3 weeks, 3-4 times for inguinal, popliteal region and ankle for a total of 12 weeks. Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise).
• Low Level Laser
Low Density Laser treatment will be applied for the first 4 weeks every 12 weeks, the remaining 8 weeks 2 days / week. A total of 9 regions (6 point inguinal region and 3 points popliteal region) are to be applied by applying the laser head close to the skin (20000 Hz, 1.5 J / cm2) with the laser device and the regions where lymph nodes and lymph pathways are dense. During the application, the patient will be in the supine position for the popliteal region, with the patient in the supine position for the inguinal region and the legs free in the abdomen.Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise).
• Complex Decongestive Physiotherapy
Complex Decongestive Physiotherapy (CDP) consists of four basic components and two phases. Four basic components; Manual lymph drainage (MLD), skin care, compression therapy and therapeutic exercise. Phase I (intense phase): It is also referred to as the phase of reducing the remission. In this phase, skin care and compression bandages are renewed after daily MLD application. The patient is taught how to bandage on his own. (Phase I, 4 weeks) The duration of phase I may vary according to the patient. In Phase II, MLD can be administered 2 or 3 times per week depending on the needs of the individual. In this case, the patient is followed by home program. Our cases will be treated in Phase I every day for 12 weeks in total and 2 days / week in Phase II according to KBF phases. All patients in this group have received only Complex Decongestive Physiotherapy.

Locations

Country	Name	City	State
Turkey	Istanbul University Faculty of Health Science	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life		12 weeks
Secondary	Lower-extremity-circumference		12 weeks
Secondary	Numeric rating scale		12 weeks
Secondary	6 minutes walking test		12 weeks
Secondary	Tissue dielectric constant Questionnaire		12 weeks