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Recruitment during pandemic was impossible to achieve
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This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT | Active Comparator | Osteopathic manual treatment |
|
| OMT plus self-massage | Active Comparator | Patients will be submitted to OMT and then they will be invited to practice a self-massage at home. |
|
| Placebo | Sham Comparator | Similar to OMT without pressure. |
|
| Placebo plus self-massage | Active Comparator | Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic treatment | Other | Manual treatment that aims to release myofascial tensions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women underwent to a c-section
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| Name | Affiliation | Role |
|---|---|---|
| Carolina Lavazza, MSc | Studio Osteopatico Busto Arsizio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Osteopatico Busto Arsizio | Busto Arsizio | Varese | Italy |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| D000267 | Tissue Adhesions |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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randomized triple-blinded
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The gynecologist, the radiologist and the statistician will be blinded to group allocation.
Participants will have similar manual treatments.
| Placebo treatment | Other | Similar to OMT without pressure |
|
| Self-massage | Other | Women will be instructed to perform self-massage at home once a day for 5 minutes. |
|
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 |
| D012046 | Rehabilitation |