The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
NCT ID: NCT04125498
Last Updated: 2022-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
50 participants
INTERVENTIONAL
2019-12-01
2025-12-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Participants will have similar manual treatments.
Study Groups
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OMT
Osteopathic manual treatment
Osteopathic treatment
Manual treatment that aims to release myofascial tensions
OMT plus self-massage
Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.
Osteopathic treatment
Manual treatment that aims to release myofascial tensions
Self-massage
Women will be instructed to perform self-massage at home once a day for 5 minutes.
Placebo
Similar to OMT without pressure.
Placebo treatment
Similar to OMT without pressure
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.
Placebo treatment
Similar to OMT without pressure
Self-massage
Women will be instructed to perform self-massage at home once a day for 5 minutes.
Interventions
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Osteopathic treatment
Manual treatment that aims to release myofascial tensions
Placebo treatment
Similar to OMT without pressure
Self-massage
Women will be instructed to perform self-massage at home once a day for 5 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* uterine prolapse
* scar treatments already performed (both manual and medical)
* absence of scar adhesions
18 Years
45 Years
FEMALE
Yes
Sponsors
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Studio Osteopatico Busto Arsizio
OTHER
Responsible Party
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Principal Investigators
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Carolina Lavazza, MSc
Role: PRINCIPAL_INVESTIGATOR
Studio Osteopatico Busto Arsizio
Locations
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Studio Osteopatico Busto Arsizio
Busto Arsizio, Varese, Italy
Countries
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Other Identifiers
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S-Care pilot
Identifier Type: -
Identifier Source: org_study_id
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