Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
Primary Purpose
Lower Extremity Lymphedema
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PRP method
Low Level Laser
Complex Decongestive Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lower Extremity Lymphedema focused on measuring Lower Extremity Lymphedema, Physiotherapy, Complex Decongestive Physiotherapy, Low Level Laser, Platelet rich plasma
Eligibility Criteria
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
Sites / Locations
- Istanbul University Faculty of Health Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Platelets / Platelet Enriched Plasma Regard (PRP) Method
Complex Decongestive Physiotherapy
Low Level Laser
Arm Description
Outcomes
Primary Outcome Measures
Health-related quality of life
Secondary Outcome Measures
Lower-extremity-circumference
Numeric rating scale
6 minutes walking test
Tissue dielectric constant Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03080207
Brief Title
Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Lymphedema
Keywords
Lower Extremity Lymphedema, Physiotherapy, Complex Decongestive Physiotherapy, Low Level Laser, Platelet rich plasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelets / Platelet Enriched Plasma Regard (PRP) Method
Arm Type
Experimental
Arm Title
Complex Decongestive Physiotherapy
Arm Type
Experimental
Arm Title
Low Level Laser
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
PRP method
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Low Level Laser
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Complex Decongestive Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-related quality of life
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lower-extremity-circumference
Time Frame
12 weeks
Title
Numeric rating scale
Time Frame
12 weeks
Title
6 minutes walking test
Time Frame
12 weeks
Title
Tissue dielectric constant Questionnaire
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Akgul, Prof.Dr.
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ela Tarakci, Assoc.Dr.
Organizational Affiliation
Istanbul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nilay Arman, PhD, PT
Organizational Affiliation
Istanbul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tugba Civi, PT
Organizational Affiliation
Istanbul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Musa Cirak, MD, DR
Organizational Affiliation
Bakirkoy Dr.Sadi Konuk Education and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University Faculty of Health Science
City
Istanbul
ZIP/Postal Code
34740
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32073990
Citation
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.
Results Reference
derived
Learn more about this trial
Platelet Rich Plasma, Complex Decongestive Physiotherapy and Low Level Laser in Treatment of Lower Extremity Lymphoedema
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