Lymphoedema. Postmastectomy lymphoedema syndrome
Conditions
Interventions
Intervention 1: Control group: Combined decongestive therapy. Includes manual lymph drainage technique (for 30 minutes) by Foldi method , multi-layered compression bandage, skin and nail care educatio
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Performing a total/partial mastectomy, or lumpectomy (with or without axillary lymph node dissection) and diagnosing unilateral lymphedema stage 2 (based on the World Society of Lymphology classification) following breast cancer by a physician Confirmed lymphedema according to the following criteria (at least one of the following conditions must be present): At least 2 cm difference in the circumference of the two upper limbs At least 10% difference in the volume of the two upper limbs At least 200 ml difference in the volume of the two upper limbs Completion of chemotherapy or radiotherapy treatment sessions at least 6 weeks prior to study entry Receiving at least one of the treatments chemotherapy or radiotherapy in addition to breast surgery BMI<35
Exclusion criteria
Exclusion criteria: Breast cancer recurrence or metastasis to other areas Infection History of lymphedema treatment in the past 6 months Untreated cardiovascular and kidney diseases Deep vein thrombosis or other vascular pathologies in the upper extremities Uncontrolled hypertension Communication disorders and mental problems Neuromuscular disease that causes sensory disturbances, decreased deep tendon reflexes, and changes in motor strength History of cellulitis in the last 6 weeks (redness, swelling, and sudden pain in a lymphatic organ) Severe joint pain or deformity due to arthritis or any other musculoskeletal problem History of shoulder or upper extremity surgery or deep scarring from wounds or burns in the upper extremity and upper trunk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the thickness of cutaneous and subcutaneous tissue on the affected and non affected sides of patients with lymphedema. Timepoint: Before the interventions start and after the treatment sessions are completed. Method of measurement: Sonography.;Shear wave velocity and tissue stiffness of the subcutaneous tissue. Timepoint: Before the interventions start and after the treatment sessions are completed. Method of measurement: Sonoelastography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tissue stiffness distribution in Elastogram. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: Image J software.;Volume of affected and non affected upper limb. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: Water displacement volumetry.;Circumference of affected and non affected upper limb. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: Tape.;Pressure pain threshold. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: Pressure algometer.;Pain intansity. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: Numeric Pain Rating Scale.;Shoulder range of motion. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: Goniometer.;Quality of life. Timepoint: Before the start of interventions and after the completion of treatment sessions. Method of measurement: LLIS1 questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSahar Zamani
Tehran University of Medical Sciences
Outcome results
None listed