Shockwave in Postoperative Breast Reconstruction Fibrosis

A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.

This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.

Study Overview

• Status: Recruiting
• Conditions: Fibrosis Breast
• Intervention / Treatment: Device: Pulsed Acoustic Cellular Expression therapy

Detailed Description

This study was conducted as a single-blind, randomized controlled trial (RCT) to evaluate the efficacy of acoustic shockwave therapy in treating post-surgical fibrosis following breast reconstruction. The intervention period spanned four weeks, during which participants received a total of eight treatment sessions-two sessions per week. Participants returned for follow-up evaluation at three months. Patients were randomized to either the intervention arm, which received active shockwave therapy, or the control arm, which received a sham (placebo) version of the therapy. Randomization was performed using a computer. Participants were blinded to treatment group allocation; however, clinicians administering the therapy were not, due to the procedural nature of the intervention.

Eligible patients included adult females with clinically diagnosed postoperative fibrosis after breast reconstruction. Patients with prior radiation exposure or capsular contracture were included and stratified by indication into three categories: post-breast reconstruction fibrosis without radiation, (1) post-breast reconstruction fibrosis following radiation, and (2) post-breast reconstruction fibrosis with capsular contracture. Demographic data including age and race/ethnicity were collected. Patients with active infection, systemic illness, or pregnancy were excluded.

The shockwave therapy group received eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2. Therapy parameters (e.g. number of pulses) were adjusted based on the anatomical location and severity of fibrosis, in accordance with manufacturer guidelines. The control group underwent the same schedule and treatment setup using the same equipment, but with the shockwave component disabled to serve as a placebo.

Outcome measures were assessed at each session (1-8) and at 3 months. Patient-reported outcomes included perceived change in fibrosis size (rated 1-10, with 10 being the greatest reduction), softness/pliability (10 being softest), pain (10 indicating worst pain), and shoulder mobility (10 indicating greatest mobility). Observer-based clinical outcomes included assessments of size (10 = largest), contour (10 = worst), firmness (10 = hardest), shoulder mobility (10=full mobility) and overall impression (10 = worst quality). In addition, scar area was measured objectively in square millimeters using caliper measurements. Video recordings of the treated areas were collected at visit to qualitatively assess visual changes over time. In addition to clinical and patient-reported outcomes, point-of-care handheld ultrasound (POCUS) was used to qualitatively assess tissue characteristics at baseline and at session 8 follow-up. Ultrasound evaluations were performed using a standardized protocol by a trained study team member. Recordings were analyzed qualitatively using a 5-point Likert scale across five domains: (1) fibrosis size, (2) echogenicity, (3) homogeneity, and (4) boundary definition. Higher scores indicated more favorable healing outcomes. Comparisons between treatment and placebo groups were conducted using the Wilcoxon rank-sum test due to the ordinal nature of the scoring system.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoinette Nguyen; Phone Number: 312-695-6022; Email: antoinette.nguyen@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Lavin Pavilion Suite 2060
      • Contact: Antoinette Nguyen; Phone Number: 312-695-6022; Email: antoinette.nguyen@northwestern.edu
      • Principal Investigator: Robert D. Galiano, MD, FACS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects greater than 18 years of age.
• Subjects who have undergone plastic surgery procedures and present in the post-operative period with soft tissue firmness suggestive of subcutaneous/parenchymal fibrosis.

Exclusion Criteria:

• Subjects with cardiac pacemakers
• Other medical or psychiatric condition that may increase the risk associated with study participation, may complicate subject compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
• Proximity of fibrotic tissue directly adjacent to bone
• Face/neck areas are excluded
• Patients who, in the opinion of the investigator, would not be compliant with the schedule of study visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control arm receives eight sessions of a sham (placebo) version of the therapy.
Experimental: Intervention; The intervention arm receives eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2	Device: Pulsed Acoustic Cellular Expression therapy; The therapy involves the delivery of targeted acoustic energy that initiates cellular mechanotransduction pathways, inducing beneficial biological responses such as enhanced angiogenesis, modulation of fibroblast proliferation and differentiation, and reorganization of aberrant extracellular matrix components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subcutaneous Fibrosis Mass	Change in size of subcutaneous fibrosis mass assess clinically by PI, point-of-care ultrasound, caliper measurements, and objective/subjective measures by an observer and the patient. Score values range from 1 to 10 with a higher score indicating a worse outcome.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Any adverse events associated with the focused shockwave therapy	Three months
Pain Score	Pain scores and change. Subjects who presented with shoulder mobility issues complete the DASH questionnaire. Score values range from 1 to 5 with a higher score indicating greater pain.	One month

Collaborators and Investigators

• Sponsor: Northwestern University

Publications and helpful links

General Publications

• Nguyen AT, Chon J, Li RA, Melnick BA, Abu-Romman A, Laiwalla R, Adam TH, Galiano RD. Extracorporeal shockwave therapy improves post-breast reconstruction fibrosis: A randomized controlled blinded clinical trial. J Plast Reconstr Aesthet Surg. 2025 Nov;110:7-17. doi: 10.1016/j.bjps.2025.08.045. Epub 2025 Sep 9.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: shockwave therapy; breast fibrosis; postoperative fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: STU00221726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes