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72 Participants NeededMy employer runs this trial

TECAR/EMS Therapy for Endometriosis

MC
Overseen ByMelanie Carminati, PT, DPT, GTS, NCPT
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: SWIMS America Corp.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study compares two ways of delivering a combined radiofrequency (RET), muscle stimulation (Hi-EMS), and pulsed radiofrequency (Hi-TENS) therapy, hands-on by a physical therapist or hands-free using adhesive pads, and compares the combined therapy to hands-on manual therapy alone for pelvic pain in women with endometriosis. Participants attend 8 sessions over 6 weeks.

Who Is on the Research Team?

MC

Melanie Carminati, PT, DPT, GTS, NCPT

Principal Investigator

Inspira Physical Therapy

Are You a Good Fit for This Trial?

This trial is for women with endometriosis who are experiencing pelvic pain. Participants should be able to attend 8 treatment sessions over 6 weeks.

Inclusion Criteria

Able to provide written informed consent
I have pelvic pain caused by endometriosis.
I am a woman age 18 or older diagnosed with endometriosis.
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Exclusion Criteria

Inability to tolerate electrical stimulation per participant report during device calibration
I currently have or may have a blood clot or uncontrolled clotting problem.
Presence of a cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic device
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Hands-on manual pelvic floor physical therapy
  • Winback BACK4 - hands-free Pelvic+
  • Winback BACK4 - hands-on TECAR+EMS

Trial Overview

The study compares two types of combined radiofrequency and muscle stimulation therapy (one delivered by a therapist, one using adhesive pads) against standard hands-on manual physical therapy for pelvic pain relief.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Hands-Free Pelvic+Experimental Treatment1 Intervention
Group II: Arm A: Hands-On TECAR+EMSExperimental Treatment1 Intervention
Group III: Arm C: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SWIMS America Corp.

Lead Sponsor

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