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Scar Treatments for Post-Cesarean Section Pain

N/A
Recruiting
Research Sponsored by Jennifer Loomis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If subject has had prior Scar Deactivation with Surface Release Technique for cesarean section scar they must have completed a washout period of 12 weeks or more.
Female DoD beneficiaries age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I completed a 12-week break after having Scar Deactivation for my cesarean section scar.
Select...
I am a female over 18 and a beneficiary of the Department of Defense.
Select...
I am over 3 months postpartum and started having abdominal/back pain after a C-section.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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%, ...)

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.

Find a Location

Who is running the clinical trial?

Jennifer LoomisLead Sponsor
Mike O'Callaghan Military HospitalFED
32 Previous Clinical Trials
73,107 Total Patients Enrolled

Media Library

Scar Deactivation Surface Release Technique protocol Clinical Trial Eligibility Overview. Trial Name: NCT03936309 — N/A
Scarring Research Study Groups: Scar Deactivation Surface Release, Scar Infiltration with 0.25-1% Lidocaine, Physical Therapy
Scarring Clinical Trial 2023: Scar Deactivation Surface Release Technique protocol Highlights & Side Effects. Trial Name: NCT03936309 — N/A
Scar Deactivation Surface Release Technique protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03936309 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment into this experiment still available for participants?

"Yes, clinicaltrials.gov indicates that this medical experiment has opened its enrolment process. This research project was first posted in June 2019 and recently updated on April 5th 2022; it requires 60 participants from a single site."

Answered by AI

How many applicants are eligible for this experiment?

"Affirmative. On clinicaltrials.gov, it is apparent that this experiment began on June 1st 2019 and has recently been updated on April 5th 2022. It appears to be actively seeking 60 individuals from a single research site for the trial."

Answered by AI
Recent research and studies
~8 spots leftby Jan 2025