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Extracorporeal shockwave therapy improves post-breast reconstruction fibrosis: A randomized controlled blinded
Antoinette T Nguyen1, Jeewon Chon2, Rena A Li3
1University of Rochester School of Medicine, Rochester, NY, USA.
Background:
Fibrosis following breast reconstruction is a debilitating syndrome characterized by (1) restricted shoulder and upper extremity mobility, (2) chronic pain and discomfort, (3) poor tissue pliability, and (4) suboptimal aesthetic outcomes. This condition significantly impairs the quality of life and functional recovery. Currently, no therapeutics directly target fibrotic remodeling. Extracorporeal shockwave therapy (ESWT) uses targeted acoustic pulses to stimulate cellular regeneration, collagen remodeling, and tissue softening, and may offer a novel non-invasive intervention.
Methods:
A single-blinded randomized controlled clinical trial was conducted in 40 adult women with clinically diagnosed postoperative fibrosis following breast reconstruction. Participants were randomized to receive either ESWT or sham treatment, delivered in eight biweekly sessions over four weeks, with follow-up at three months. The primary outcome was patient-reported breast softness. Secondary outcomes included pain, fibrosis size, shoulder mobility, observer assessments, and ultrasound-based tissue quality.
Results:
Compared to the placebo group, the ESWT group demonstrated significantly greater improvements in breast softness (mean change: 4.92 ± 1.86 vs. 0.9 ± 1.48; p = 0.00003), pain (-2.00 ± 2.28 vs. +0.43 ± 2.16; p = 0.0052), and fibrosis size (3.88 ± 1.82 vs. 0.86 ± 1.59; p = 0.0015). Observer-rated outcomes also favored the treatment, including breast firmness (-2.12 ± 1.55 vs. -0.14 ± 1.77; p = 0.0013) and overall opinion (-2.04 ± 1.78 vs. -0.43 ± 1.74; p = 0.0003). Ultrasound scores improved across all metrics, including fibrosis depth (1.08 ± 0.74 vs. 0.57 ± 0.51; p = 1.57 × 10⁻⁵) and boundary definition (1.23 ± 0.65 vs. 0.29 ± 0.47; p = 5.30 × 10⁻⁵).
Conclusion:
ESWT significantly improved pain, softness, lesion size, and sonographic fibrosis features in patients with post-reconstruction fibrosis, demonstrating strong and sustained therapeutic benefit.
Clinical Trial Registration:
NCT06919042.
