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IRCT20250304064934N1 IRCT 2025-04-13 Tehran University of Medical Sciences Comparison of myofascial release and intermittent pneumatic compression in breast cancer related lymphedema Comparison of the additional effect of myofascial release or intermittent pneumatic compression on combined decongestive therapy in improving Sonography and Sonoelastographic parameters and clinical symptoms in women with breast cancer related lymphoedema 2025-04-20 anticipated 45 Complete https://irct.ir/trial/82332 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method with a block size of 6 will be divided equally (ratio 1:1:1) into three groups, Blinding description: Patient assessment will be performed by a blinded radiologist and physiotherapist who are unaware of the type of intervention the patients are receiving. N/A Lymphoedema. 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 education, and specific lymphatic drainage exercises. Patients in this group will receive 10 sessions, 5 times a week, for two weeks. Intervention 2: Intervention group: Myofascial release plus combined decongestive therapy. In addition to combined decongestion therapy, patients will receive fascial release techniques using gross stretch techniques for superficial tissues and focused stretch for more restricted tissues. This treatment will be performed on the anterior and posterior chest, pectoralis major and minor, latissimus dorsi, upper and middle trapezius, infraspinatus, supraspinatus, levator scapulae and deltoid, and scar fascia at the surgical site for a total of 30 minutes. The technique will be continued in each area until the release of restricted fascia is felt under the examiner's hand. The number of treatment sessions will be 10, the duration will be two weeks, and 5 times a week. Intervention 3: Intervention group: Intermittent pneumatic compression plus combined decongestive therapy. In this group, in addition to the combined decongestion Therapy performed in the control group, the LX9 intermittent pneumatic compression device (4-chamber type) manufactured by Daesung Maref, South Korea, will also be used. the upper limb with lymphedema will be placed inside a flexible multi-chamber sleeve for 30 minutes at a pressure of 40-60 mm Hg with a inflation time of 60 seconds and a deflation time of 25 seconds. Patients will receive 10 sessions, 5 times per week, for two weeks. Yes - There is a plan to make this available What will be shared: Information of outcomes before and after the intervention can be shared. All results from primary and secondary assessments will be presented as averages in Excel. When: Access starts 6 months after publishing of the results To whom: Access is possible for researchers working in academic and scientific institutions Conditions: They can use the results for systematic review. Access is possible if academic and scientific responsibility is established. Where to obtain: Applicants can send their application to the researcher's email address. sahar_zamanipt87@yahoo.com How to obtain: The applicant can access the information by providing valid proof of academic affiliation to the university by sending this proof to the researcher's email Comments:
public Sahar Zamani
Rehabilitation faculty, Piche Shemiran, Engelab st, District 12, Tehran
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 S_zamanipt@tums.ac.ir Tehran University of Medical Sciences scientific Azadeh Shadmehr
Rehabilitation faculty of Tehran,Safi Alishah st, Pich Shemran, Enghelab st
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 shadmehr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 25 years 65 years Female 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 I97.2 Postmastectomy lymphoedema syndrome Treatment - Other Treatment - Other Treatment - Other Control group: Combined decongestive therapy. Includes manual lymph drainage technique (for 30 minutes) by Foldi method , multi-layered compression bandage, skin and nail care education, and specific lymphatic drainage exercises. Patients in this group will receive 10 sessions, 5 times a week, for two weeks. Intervention group: Myofascial release plus combined decongestive therapy. In addition to combined decongestion therapy, patients will receive fascial release techniques using gross stretch techniques for superficial tissues and focused stretch for more restricted tissues. This treatment will be performed on the anterior and posterior chest, pectoralis major and minor, latissimus dorsi, upper and middle trapezius, infraspinatus, supraspinatus, levator scapulae and deltoid, and scar fascia at the surgical site for a total of 30 minutes. The technique will be continued in each area until the release of restricted fascia is felt under the examiner's hand. The number of treatment sessions will be 10, the duration will be two weeks, and 5 times a week. Intervention group: Intermittent pneumatic compression plus combined decongestive therapy. In this group, in addition to the combined decongestion Therapy performed in the control group, the LX9 intermittent pneumatic compression device (4-chamber type) manufactured by Daesung Maref, South Korea, will also be used. the upper limb with lymphedema will be placed inside a flexible multi-chamber sleeve for 30 minutes at a pressure of 40-60 mm Hg with a inflation time of 60 seconds and a deflation time of 25 seconds. Patients will receive 10 sessions, 5 times per week, for two weeks. 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. 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. Tehran University of Medical Sciences Approved 2025-02-17 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)