Clinical trial NCT06919042: Shockwave in Postoperative Breast Reconstruction Fibrosis
Official title: A Prospective Single-center Study for Evaluation of the Effectiveness of Pulsed Acoustic Cellular Expression Technology on Post-Operative Soft Tissue Fibrosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrosis Breast
Keywords: breast fibrosis
postoperative fibrosis
shockwave therapy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subcutaneous Fibrosis Mass
timeFrame: One month
Secondary outcomes:
measure: Pain Score
timeFrame: One month
measure: Adverse Events
timeFrame: Three months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lavin Pavilion Suite 2060
state: Illinois
Study officials:
References: