Scar Treatments for Post-Cesarean Section Pain

Overseen By Amanda J Crawford, BA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jennifer Loomis

Disqualifiers: Pregnant, Active cellulitis, others

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

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare scar infiltration with 0.5-1% Lidocaine at a dose of 3 mg/kg (max dose 300 mg) or scar deactivation with acupuncture surface release technique to determine which is more effective in reducing pain in adult patients with chronic, post-surgical pain related to the site of incision after low transverse Cesarean section compared to standard of care physical therapy with the McKenzie Method.

Eligibility Criteria

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.

Inclusion Criteria

I completed a 12-week break after having Scar Deactivation for my cesarean section scar.

Patients must be able to get care at Nellis Air Force Base or Scott AFB (a military installation)

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

Exclusion Criteria

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

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

You have had a cesarean section with lidocaine injected into the scar.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either scar infiltration with Lidocaine, scar deactivation with acupuncture, or standard physical therapy using the McKenzie Method

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Physical therapy
• Scar Deactivation Surface Release Technique protocol
• Scar Infiltration with 0.25-1% Lidocaine

Trial Overview 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.

Participant Groups

Group I: Scar Infiltration with 0.25-1% Lidocaine Experimental Treatment 1 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 Release Experimental Treatment 1 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 Therapy Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Jennifer Loomis

Lead Sponsor

Trials

1

Recruited

60+

Mike O'Callaghan Military Hospital

Collaborator

Trials

33

Recruited

73,100+