The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study. (S-CARE)

This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.

Study Overview

• Status: Suspended
• Conditions: Cesarean Section Complications; Cesarean Section; Complications, Wound, Infection (Following Delivery)
• Intervention / Treatment: Other: Osteopathic treatment; Other: Self-massage; Other: Placebo treatment

Detailed Description

The rates of caesarean sections are growing throughout the world, with recent rates (in 2016) in Europe of 25%, in North America of 32.3% and in South America of 40.5%.

The incidence of intra-abdominal adhesions in women undergoing to repeated caesarean sections is constantly increasing.

Labor and surgical time are significantly longer in patients with adhesions compared to patients without adhesions.

Furthermore, it has been estimated that about 10% of patients undergoing cesarean section experience chronic pain.

Despite of the big impact on the quality of life of patients and high cost for public health, treatments for adhesions are mostly surgical.

The identification of non-surgical treatments that aim to reduce cicatricial adhesions' formation is essential to decrease hospitalization times and associated complications.

The purpose of this study is to evaluate the effects of osteopathic treatment and self-massage on scars in women who underwent to a cesarean section. The main aim is to assess whether there is a change in the number, size and vascularization of of cesarean section adhesionsthrough Superb Microvascular Imaging (SMI).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Varese
    • Busto Arsizio, Varese, Italy
      • Studio Osteopatico Busto Arsizio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• primiparous or multipara who have undergone a cesarean section with a completely healed scar will be included.
• women who had first menstruation after childbirth
• Women with or without pain or symptoms related to scarring or the presence of isthmocele will be included.

Exclusion Criteria:

• caesarean section performed in a period less than 6 months and over 3 years
• uterine prolapse
• scar treatments already performed (both manual and medical)
• absence of scar adhesions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OMT; Osteopathic manual treatment	Other: Osteopathic treatment; Manual treatment that aims to release myofascial tensions
Active Comparator: OMT plus self-massage; Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.	Other: Osteopathic treatment; Manual treatment that aims to release myofascial tensions; Other: Self-massage; Women will be instructed to perform self-massage at home once a day for 5 minutes.
Sham Comparator: Placebo; Similar to OMT without pressure.	Other: Placebo treatment; Similar to OMT without pressure
Active Comparator: Placebo plus self-massage; Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.	Other: Self-massage; Women will be instructed to perform self-massage at home once a day for 5 minutes.; Other: Placebo treatment; Similar to OMT without pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesions' number, size and vascularization	Evaluate through superb microvascular imaging. Correlation between adhesions and type/number of c-section	Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month
Adverse event	Number and type of adverse events	Number of adverse event occurred at one month
Uterine niches	Evaluation of the presence and dimensions of uterine niches	Changes in dimension of uterine niches at one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of osteopathic palpation through a questionnaire	Comparison between osteopathic palpation and ultrasound results in the detection of adhesions	At one week, two week and one month
Inter-reliability of ultrasound evaluation	Ultrasound results comparison between gynecologist and radiologist using a vascularization scale (grade from 0 to 4)	At one week, two week and one month
Self-massage compliance	Questionnaire	At one month
Symptoms related to scar		At one week, two week and one month

Collaborators and Investigators

• Sponsor: Studio Osteopatico Busto Arsizio
• Investigators: Principal Investigator: Carolina Lavazza, MSc, Studio Osteopatico Busto Arsizio

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: scar; adhesions; cicatrix; c-section; manual treatment
• Other Study ID Numbers: S-Care pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No