Isolated ShockWave Therapy in Lipedema

INTERVENTION: A randomized, controlled, single‐blind clinical trial will be conducted at the Physical Rehabilitation Center (PRC) of the Universidade Estadual do Oeste do Paraná (UNIOESTE ‐ State University of Western Paraná), Cascavel campus, Paraná, Brazil. The sample will consist of 44 women aged 18 years or older, with a clinical diagnosis or suspicion of stage I, II, or III lipedema, types 2, 3, or 5. Participants will be randomly allocated into two groups, with 22 participants each: the Intervention Group (GrESWT), which will undergo isolated extracorporeal radial shock wave therapy; and the Sham Control Group (GSHAM), which will receive a simulated intervention. For the sham procedure in the GSHAM group, the applicator will position the transducer over the skin region; however, the device will not emit therapeutic energy, instead producing a sound similar to the characteristic noise of the equipment to mimic treatment. The device will be programmed to deliver energy of 96 mJ at a frequency of 20 Hz, totaling 2,000 pulses per lower limb (covering thighs and legs), using a 34 mm applicator tip, with a frequency of two sessions per week for four consecutive weeks, totaling eight sessions over a one‐month period. Randomization will be performed in a 1:1 ratio using a sequence generated by specific electronic software. The study will adopt a single‐blind design, ensuring that participants remain unaware of their group allocation, and all assessments will be conducted by the same previously trained evaluator during the pre‐intervention (baseline) and post‐intervention periods. The following outcomes will be assessed: global lipedema symptomatology (Lipedema Symptom Assessment Questionnaire – QuASiL), pain intensity (Visual Analog Scale – VAS), lower limb functionality (Lower Extremity Functional Scale – LEFS), quality of life (Medical Outcomes Study 36‐Item Short‐Form Health Survey – SF‐36), edema and volumetric changes (perimetry using a non‐elastic measuring tape at standardized points), and photographic records before and after the protocol. Data will be organized in spreadsheets and analyzed using Jamovi® software. Descriptive analysis will include means and standard deviations for continuous variables and frequencies for categorical variables. For inferential analysis, generalized linear models for repeated measures will be used, considering group, time (pre‐ and post‐intervention), and the group × time interaction, with Sidak post hoc tests when necessary. The significance level will be set at 5% (p less than 0.05), and effect size will also be calculated using Cohen’s d to assess the magnitude of the results. CONDITION: A10.165.114.830.750 Lipedema ; Subcutaneous fat PRIMARY OUTCOME: Reduction in global lipedema symptomatology, characterized by a significant improvement in total clinical symptom scores following the rESWT protocol compared to baseline values. ; SECONDARY OUTCOME: Reduction in pain intensity as measured by the VAS, analysis of the severity of clinical lipedema symptoms through the QuASiL, reduction in edema and lower limb anthropometric measurements verified by perimetry, improvement in functional capacity analyzed by the LEFS, and improvement in quality of life evaluated by the SF‐36. INCLUSION CRITERIA: Women meeting the following criteria will be included in the study: a clinical diagnosis or suspicion of stage I, II, or III lipedema located in the lower limbs (types 2, 3, and 5); aged 18 years or older; no prior history of surgical treatment for lipedema; not undergoing any concomitant treatments for lipedema during the study period, including physiotherapy, aesthetic interventions, or specific pharmacological therapies; presenting the cognitive and functional capacity to understand and respond to the assessment instruments; and voluntarily agreeing to participate in the study by signing the Informed Consent Form (ICF).