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Extracorporeal Shockwave Therapy (ESWT) in Post-Breast Reconstruction Fibrosis: A Randomized Controlled Trial
Antoinette Nguyen
*1, Jeewon Chon
2, Rena A. Li
2, Bradley Melnick
2, Anmar Abu-Romman
2, Rahim Laiwalla
2, Robert Galiano
21Plastic Surgery, University of Rochester School of Medicine, Rochester, NY; 2Department of Plastic Surgery, Northwestern University, Chicago, IL
Background:Postoperative fibrosis following breast reconstruction can lead to pain, restricted mobility, aesthetic compromise, and reduced quality of life. Extracorporeal shockwave therapy (ESWT) is a non-invasive modality that delivers acoustic pulses to modulate cellular pathways and improve tissue architecture. This randomized controlled trial evaluated the clinical and sonographic efficacy of ESWT in treating post-reconstruction fibrosis.
Methods:Forty women with clinically diagnosed fibrosis after breast reconstruction were randomized to receive either ESWT (n = 26) or sham (n = 14) treatment. Participants underwent eight biweekly sessions over four weeks, with follow-up at three months. Outcomes included patient-reported measures (softness, pain, size reduction), clinician assessments (firmness, contour, overall impression), and ultrasound-based structural evaluation. Statistical analysis included Wilcoxon rank-sum tests and repeated-measures mixed models.
Results:Compared to placebo, the ESWT group demonstrated significantly greater improvements in softness (Δ = +3.99, p < 0.001), pain reduction (Δ = −2.51, p = 0.0049), and lesion size decrease (Δ = +3.03, p = 0.0015). Observer-rated outcomes also favored ESWT, including contour (Δ = −1.76, p = 0.00068) and overall opinion (Δ = −3.04, p = 0.0003). Mixed-effects modeling confirmed consistent treatment effects across all timepoints. Ultrasound analysis showed improved fibrosis depth (Δ = +1.12, p < 0.001), echogenicity (Δ = +0.58, p = 0.016), homogeneity (Δ = +0.72, p = 0.003), and boundary clarity (Δ = +0.94, p < 0.001). Results were consistent across race and indication, with the exception of reduced response in capsular contracture.
Conclusion:ESWT significantly enhances fibrosis resolution and functional outcomes after breast reconstruction, supporting its use as a safe and effective non-invasive therapy.
