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

NCT03080207 | Completed

• 1 other identifier: TSA-2017-22398
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Extremity Lymphedema

Keywords

Lower Extremity Lymphedema; Physiotherapy; Complex Decongestive Physiotherapy; Low Level Laser; Platelet rich plasma

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  12 weeks

Secondary Outcomes (4)

• Lower-extremity-circumference

  12 weeks

• Numeric rating scale

  12 weeks

• 6 minutes walking test

  12 weeks

• Tissue dielectric constant Questionnaire

  12 weeks

Study Arms (3)

Platelets / Platelet Enriched Plasma Regard (PRP) Method

EXPERIMENTAL

Procedure: PRP method

Complex Decongestive Physiotherapy

EXPERIMENTAL

Procedure: Low Level Laser

Low Level Laser

EXPERIMENTAL

Procedure: Complex Decongestive Physiotherapy

Interventions

PRP method PROCEDURE

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).

Platelets / Platelet Enriched Plasma Regard (PRP) Method

Low Level Laser PROCEDURE

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 PROCEDURE

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.

Low Level Laser

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having lower extremity lymphedema
• To be older than 18 ages.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Health Science

Istanbul, 34740, Turkey (Türkiye)

Location

Related Publications (1)

• Akgul A, Tarakci E, Arman N, Civi T, Irmak S. A Randomized Controlled Trial Comparing Platelet-Rich Plasma, Low-Level Laser Therapy, and Complex Decongestive Physiotherapy in Patients with Lower Limb Lymphedema. Lymphat Res Biol. 2020 Oct;18(5):439-447. doi: 10.1089/lrb.2019.0064. Epub 2020 Feb 19.

  PMID: 32073990 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Ahmet Akgul, Prof.Dr.

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Ela Tarakci, Assoc.Dr.

  Istanbul University

  STUDY DIRECTOR

• Nilay Arman, PhD, PT

  Istanbul University

  STUDY DIRECTOR

• Tugba Civi, PT

  Istanbul University

  STUDY DIRECTOR

• Musa Cirak, MD, DR

  Bakirkoy Dr.Sadi Konuk Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 15, 2017
• Study Start: January 17, 2017
• Primary Completion: August 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)