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A Comparison of Scar Infiltration, Scar Deactivation, and Standard of Care for the Treatment of Chronic, Post-Surgical Pain After Cesarean Section

NCT03936309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Scar
  • Cesarean Section; Dehiscence

Interventions

OTHER

Scar Deactivation Surface Release Technique protocol

▪ 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.

OTHER

Scar Infiltration with 0.25-1% Lidocaine

▪ 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.

OTHER

Physical therapy

▪ 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.

Sponsors & Collaborators

  • Mike O'Callaghan Military Hospital

    collaborator FED

  • Jennifer Loomis

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2025-04-08
Completion
2025-04-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936309 on ClinicalTrials.gov