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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to reduce chronic pain from C-section scars. It compares two methods: injecting Lidocaine (a numbing medicine) directly into the scar and using acupuncture needles around the scar as part of the Scar Deactivation Surface Release Technique protocol. The trial also compares these methods with standard physical therapy exercises. Women who are at least three months postpartum and have ongoing pain from a C-section scar might be suitable candidates, especially if they can receive care at Nellis Air Force Base or Scott AFB. As an unphased trial, this study offers a unique opportunity to explore innovative pain relief methods for C-section scars.

Do I need to stop my current medications to join the trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both scar deactivation and lidocaine infiltration are generally well-tolerated for easing pain after a cesarean section.

Scar deactivation involves placing acupuncture needles around the scar and is often used to help with pain. Studies have found it effective in managing pain without major side effects.

Lidocaine infiltration uses lidocaine to numb the area around a cesarean scar, which can reduce pain. Previous studies reported no major side effects, making it a safe option for many patients.

In summary, both treatments are considered safe for managing pain in post-cesarean scars, with no significant safety issues reported in existing studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these scar treatment techniques for post-cesarean section pain because they offer innovative approaches compared to standard care like topical creams or surgical scar revisions. The Scar Deactivation Surface Release Technique uses acupuncture needles around the scar, aiming to relieve pain through precise needle placement, which differs from typical direct scar treatments. On the other hand, injecting Lidocaine directly into the scar tissue offers a targeted numbing effect, potentially providing immediate relief without systemic side effects. Lastly, the inclusion of physical therapy using the McKenzie protocol helps address pain by identifying and correcting postural issues, offering a holistic approach that goes beyond conventional pain management.

What evidence suggests that this trial's treatments could be effective for post-cesarean section pain?

In this trial, participants will join different treatment arms to manage post-C-section scar pain. One arm will use the Scar Deactivation Surface Release Technique, which involves acupuncture techniques that previous studies have shown to reduce scar-related pain. Another arm will involve Scar Infiltration with Lidocaine, a local pain reliever, which research supports as effective in significantly lessening pain and reducing the need for additional pain medication. The third arm will involve Physical Therapy, specifically the McKenzie method, which has proven to help reduce pain and improve satisfaction after a C-section. Each of these treatments shows potential in managing post-surgical pain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8812015/

Effectiveness of face-to-face physiotherapy training and ... The effect of conservative physiotherapy techniques, has shown to reduce post-operative pain, incision related adhesions and diastasis [18].

2. muhealth.org muhealth.org/our-stories/physical-therapy-after-c-section-improves-outcomes

Physical Therapy After C-Section Improves Outcomes A new study shows women who received physical therapy after a C-Section had higher satisfaction and less pain.

3. orthopt.org orthopt.org/uploads/content_files/files/Cesarean_Section_Delivery_Pain.pdf

Research Reviews Cesarean Section Delivery Pain Physical therapy (PT) interventions to improve physical measures of health post-CSD may decrease pain and improve function. Evidence for the effectiveness of PT ...

4. researchgate.net researchgate.net/publication/319062858_Effective_Physical_Therapy_Treatment_of_Post-Cesarean_Section_Low_Back_Pain_-_Case_Report

Effective Physical Therapy Treatment of Post-Cesarean ... Conclusion The back pain exercise reducing program was effective in reducing back pain intensity and analgesia usage with a significant ...

5. europeanjournalofmidwifery.eu europeanjournalofmidwifery.eu/Impact-of-obstetric-physiotherapy-and-transcutaneous-electrical-nerve-stimulation,191740,0,2.html

Impact of obstetric physiotherapy and transcutaneous ... Conclusions: The proposed physiotherapy program, combined with TENS and instruction, proved effective in relieving post-cesarean pain and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9701535/

Complementary and alternative therapies for post‐caesarean ... Complementary and alternative therapies (CAM) may be a safe way of reducing pain after a CS without adverse effects. What is the question? What are the effects ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846434/

Comparison of postoperative pain severity between ... There was a high Risk of moderate to severe postoperative pain in repeated caesarean section compared to primary caesarean section in both ...

8. research.aota.org research.aota.org/ajot/article/79/1/7901347030/26041/Occupational-Therapists-Role-in-Maternal-Health-in

Occupational Therapists' Role in Maternal Health in the Home ... PTs typically address low back pain, core rehabilitation, scar management, and pelvic floor dysfunction in the c-section postpartum population ...