Shockwave Therapy for Fibrosis of the Breast

Overseen By Antoinette Nguyen

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Cardiac pacemakers, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether shockwave therapy, known as Pulsed Acoustic Cellular Expression therapy, can reduce hard tissue lumps that form after plastic surgery. Participants will receive sound wave treatments to determine if it softens tissue. Some will receive the actual therapy, while others will receive a placebo for comparison. Individuals who have undergone plastic surgery and notice firm areas in healing skin might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could improve post-surgical recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this therapy is safe for treating fibrosis of the breast?

Research suggests that Pulsed Acoustic Cellular Expression (PACE) therapy might be safe for people. Studies have shown that a similar treatment, extracorporeal shockwave therapy, is effective and generally well-tolerated. Patients using these therapies reported improvements without major side effects. The therapy sends sound waves to heal tissues and reduce swelling. This suggests that PACE therapy could be safe for treating fibrosis, which is thickened tissue, in the breast. However, more research is needed to confirm these findings, as this trial remains in the early stages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for breast fibrosis, which often include surgery or corticosteroid injections, Pulsed Acoustic Cellular Expression (PACE) therapy uses sound waves to target the affected tissue. This non-invasive approach is unique because it employs pulsed acoustic waves to stimulate cellular activity and promote tissue healing. Researchers are excited about PACE therapy because it offers a potential alternative that avoids surgery and its associated risks, while possibly accelerating recovery and improving outcomes.

What evidence suggests that Pulsed Acoustic Cellular Expression therapy might be an effective treatment for fibrosis of the breast?

Research has shown that extracorporeal shockwave therapy, also known as Pulsed Acoustic Cellular Expression (PACE) therapy, holds promise for reducing tissue hardening or thickening after breast surgery. In this trial, participants in the intervention arm will receive PACE therapy. Studies have found that it significantly improves pain, softness, and the size of affected areas in patients with fibrosis. It also exhibits strong anti-inflammatory effects, which help reduce tissue stiffness. These findings suggest that PACE therapy could effectively treat post-surgery fibrosis in the breast. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had plastic surgery and now have firmness in the tissue, suggesting fibrosis. It's not for those with pacemakers, conditions that could risk their safety or affect results, or if they can't follow the visit schedule. Fibrosis next to bone or in face/neck areas also disqualifies.

Inclusion Criteria

I have had plastic surgery and now have firmness in the tissue, suggesting scarring.

I am over 18 years old.

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

Patients who, in the opinion of the investigator, would not be compliant with the schedule of study visits

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Pulsed Acoustic Cellular Expression therapy

Trial Overview The study is testing Pulsed Acoustic Cellular Expression therapy (extracorporeal shockwave therapy) to see if it can reduce fibrosis—stiffness and scarring—in soft tissues after surgery.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention arm receives eight sessions of Pulsed Acoustic Cellular Expression (PACE) therapy delivered twice weekly for four weeks at level E2

Group II: Control Active Control 1 Intervention

The control arm receives eight sessions of a sham (placebo) version of the therapy.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. withpower.com withpower.com/trial/phase-fibrosis-9-2024-27109

Shockwave Therapy for Fibrosis of the Breast Trial Overview The study is testing Pulsed Acoustic Cellular Expression therapy (extracorporeal shockwave therapy) to see if it can reduce fibrosis—stiffness ...

2. jprasurg.com jprasurg.com/article/S1748-6815(25)00533-9/abstract

Extracorporeal shockwave therapy improves post-breast ... ESWT significantly improved pain, softness, lesion size, and sonographic fibrosis features in patients with post-reconstruction fibrosis, demonstrating strong ...

3. trial.medpath.com trial.medpath.com/clinical-trial/bf2bbc5080849163/nct06919042-pulsed-acoustic-post-operative-fibrosis

Shockwave in Postoperative Breast Reconstruction Fibrosis | MedPath This study evaluates the potential for extracorporeal shockwave therapy to reduce post-operative soft tissue fibrosis.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41038043/

Extracorporeal shockwave therapy improves post-breast ... Extracorporeal shockwave therapy improves post-breast reconstruction fibrosis: A randomized controlled blinded clinical trial. J Plast Reconstr ...

5. researchgate.net researchgate.net/publication/395510196_Extracorporeal_Shockwave_Therapy_ESWT_Improves_Post-Breast_Reconstruction_Fibrosis_A_Randomized_Controlled_Blinded_Clinical_Trial

A Randomized Controlled Blinded Clinical Trial Recent studies have shown that pulsed acoustic cellular expression (PACE) has significant antiinflammatory effects.

6. trialx.com trialx.com/clinical-trials/listings/309742/shockwave-in-postoperative-breast-reconstruction-fibrosis/

Shockwave in Postoperative Breast Reconstruction Fibrosis Outcome measures were assessed at each session (1-8) and at 3 months. Patient-reported outcomes included perceived change in fibrosis size ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11452247/

Clinical Efficacy and Safety of Low‐Energy Extracorporeal ... Our data demonstrated that ESWT effectively and safely improved the clinical appearance and functional movement of patients with dermal and subdermal fibrosis.