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Scar Treatments for Post-Cesarean Section Pain

N/A

Waitlist Available

Research Sponsored by Jennifer Loomis

Eligibility Criteria Checklist

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

Must have

Female DoD beneficiaries age 18 years or older

3 months or greater postpartum with abdominal and/or back pain starting after low transverse Cesarean section scar.

Must not have

Vertical incision or emergent Cesarean section

Prior Scar Deactivation with Surface Release Technique for cesarean section scar within the last 12 weeks.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two methods to reduce post-surgical pain related to a Cesarean section. One method is scar infiltration with Lidocaine and the other is scar deactivation with acupuncture.

Who is the study for?

This trial is for female DoD beneficiaries, 18 or older, who are experiencing abdominal/back pain starting after a low transverse Cesarean section and are at least 3 months postpartum. They must be able to receive care at specific military bases and not have had certain scar treatments recently.

What is being tested?

The study compares three approaches for chronic pain after Cesarean sections: injecting Lidocaine into the scar, using an acupuncture-like technique called Scar Deactivation Surface Release, and standard physical therapy. It aims to find out which method best reduces pain.

What are the potential side effects?

Lidocaine injections might cause temporary discomfort, bruising or infection at the injection site. The acupuncture-like technique could result in minor bleeding or soreness. Physical therapy may lead to muscle soreness.

Eligibility Criteria

Inclusion Criteria

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

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I am a female over 18 and a beneficiary of the Department of Defense.

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I am over 3 months postpartum and started having abdominal/back pain after a C-section.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a C-section with a vertical cut or it was an emergency.

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I had a procedure to treat my cesarean section scar within the last 3 months.

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I have an infection around a scar.

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I have had surgery to correct a Cesarean section scar.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Defense and Veterans Pain Rating Scale (DVPRS) between each time frame

Change in Patient and Observer Scar Assessment Scale (POSAS) between each time frame

Secondary study objectives

Single question asking if subjects' expectations were met? -- Binary yes/no

Single question asking subjects' change in pain severity reported as a percentile (10%, 20%, ...)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Scar Infiltration with 0.25-1% LidocaineExperimental Treatment1 Intervention

Will consist of calculation of 3 mg/kg dose of 0.5-1% Lidocaine and a dermal followed by subcutaneous injection using 1.5 inch 25 G needle and syringe appropriate for volume based on calculated dose.

Group II: Scar Deactivation Surface ReleaseExperimental Treatment1 Intervention

Alternating placement of Spring Ten (0.30x40 mm) acupuncture needles to surround scar left in place for a treatment duration of 20 minutes. Needles will be placed at intervals of 1cm to 1.5 cm and will surround the scar with a maximum of 20 needles per treatment.

Group III: Physical TherapyExperimental Treatment1 Intervention

Will be a referral to physical therapy specifying McKenzie protocol treatment for the presenting complaint. The McKenzie protocol is a form of standard of care physical therapy in which the physical therapist tries to find a cause and effect relationship between the positions the patient usually assumes while sitting, standing, or moving, and the location of pain because of those positions or activities. The therapeutic approach requires a patient to move through a series of activities and test movement to gauge the patient's pain response. The approach then uses that information to develop an exercise program designed to centralize or alleviate the pain.

0 / 6Eligibility criteria met