What side effects are associated with this type of intervention?

The most common side effects of treatments involving physical manipulation and massage of perineal scar tissue include temporary discomfort or pain during the massage, minor bruising, and potential irritation of the scar tissue. Some patients may experience increased sensitivity or mild swelling in the treated area. These side effects are generally mild and transient, resolving shortly after the treatment session.

What prior FDA approvals exist?

There are no specific FDA approvals for the treatment of perineal tears using self-scar tissue massage or similar physical manipulation techniques. However, physical therapy and manual manipulation techniques are commonly recommended by healthcare providers to improve tissue flexibility, reduce pain, and enhance pelvic function in postpartum women. These therapies are generally considered safe and effective, although they may not have specific FDA approval as a treatment modality for perineal tears.

What other types of research exist?

Promising novel alternatives to self-scar tissue massage for perineal tears patients include: 1) Low-Level Laser Therapy (LLLT), which has shown potential in improving tissue healing and reducing pain. 2) Platelet-Rich Plasma (PRP) injections, which may enhance tissue regeneration and reduce inflammation. 3) Extracorporeal Shock Wave Therapy (ESWT), which can improve blood flow and tissue repair. 4) Use of advanced dressings like hydrocolloid dressings, which promote faster healing and reduce infection risk. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Episiotomy Scar Massage for Postpartum Pelvic Health (EPIS Trial)

N/A

Recruiting

Led By Erin Brennand, MD, MSc

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6-10 weeks postpartum after vaginal delivery with episiotomy

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if teaching new mothers to massage their childbirth scars can improve their pelvic health. The study will involve women who have given birth and have healed scars. The massage is expected to make the scar tissue more flexible and reduce discomfort.

Who is the study for?

This trial is for first-time mothers over 18, within 6-10 weeks postpartum after a vaginal delivery with episiotomy. They must have healed scars as confirmed by their doctor and be able to understand English well enough to follow an instructional video and fill out questionnaires.

What is being tested?

The study tests if self-scar tissue massage on the perineal area can improve pelvic health in new moms. Participants will either perform self-massage following an instructional video or receive routine care without massage, to compare outcomes using pelvic health questionnaires.

What are the potential side effects?

Since this intervention involves non-invasive self-massage, side effects are expected to be minimal but may include discomfort or pain at the scar site during or after performing the massage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 6-10 weeks postpartum after a vaginal delivery with an episiotomy.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Pelvic Floor Distress Inventory (PFDI-20) Outcome Measures with missing data

Number of The Carol Scale with missing data

Number of participants to complete self-scar massage protocol as intended

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Episiotomy and Vaginal/Perineal Tear Self-Scar MassageExperimental Treatment1 Intervention

This Arm will be instructed in and perform self-scar massage to their pelvic floor scar tissue.

Group II: Standard Postnatal CareActive Control1 Intervention

This Arm will not be instructed in or perform self-scar massage to their pelvic floor scar tissue.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for perineal tears, particularly those involving physical manipulation and massage of scar tissue, aim to improve tissue flexibility, reduce pain, and enhance pelvic function. These treatments work by breaking down adhesions and scar tissue, promoting better blood flow, and encouraging the realignment of collagen fibers within the scar. This can lead to increased elasticity and reduced discomfort in the affected area. For patients with perineal tears, these benefits are crucial as they can significantly improve postpartum recovery, alleviate pain during activities such as sitting or intercourse, and enhance overall pelvic health.