Cesarean Section ComplicationsNCT06446258
Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section
A study testing Manual therapy (myofascial release, soft tissue mobilization) in people with Cesarean Section Complications, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
The aim of the study is to assess the impact of soft tissue mobilization on the scar in patients after cesarean section. An additional aim is to assess the relationship between the initial stiffness and elasticity of the scar and the age of the patients, the number of cesarean sections performed, as well as the time… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Manual therapy (myofascial release, soft tissue mobilization)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 24 Sep 2024to 21 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women aged 18-45,
- undergone at least 1 cesarean section in a period of not less than 6 months,
- not using physiotherapy for a cesarean section scar
Who cannot join
- women under 18 and over 45,
- pregnant women,
- presence of abdominal mesh,
- condition after abdominoplasty; nephrectomy; hysterectomy; cystectomy,
- uterine fibroids,
- stoma,
Show all 14Show fewer
- occurrence of neurological symptoms (exclusion based on a functional test including the following elements: trunk flexion test in a sitting position (Slump test), Babinski test and clonic reflex test, tension tests for the sciatic nerve (passive straight leg raise test) and bowstring test and femoral nerve test (in lying on the front and on the side), examination of knee and ankle reflexes, as well as assessment of superficial sensation and strength of indicator muscles in the innervation of the lumbar-sacral spine),
- positive result of pain provocation tests: axial compression of the spine and maximum compression of the intervertebral foramen in the lumbosacral spine area,
- presence of contraindications to myofascial release therapy (active cancer, deep vein thrombosis, aneurysms, infectious diseases, viral and bacterial infections, acute inflammation and fever),
- women who underwent CC surgery in less than 6 months,
- previous surgical treatment and spine injury,
- vertical scar after cesarean section,
- use of physiotherapy treatments in the last six months,
- additionally the following comorbid conditions: cancer, diabetes, osteoporosis, diseases of the digestive system, circulatory system, rheumatic, mental and gynecological diseases, pregnancy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University
Bydgoszcz, Techników 3, 85-801
About this study
The aim of the study is to assess the impact of soft tissue mobilization on the scar in patients after cesarean section. An additional aim is to assess the relationship between the initial stiffness and elasticity of the scar and the age of the patients, the number of cesarean sections performed, as well as the time that has passed since the last cesarean section. Two physiotherapeutic interventions will be performed in the form of mobilization of the soft tissues (myofascial release techniques) of the lower abdominal area and the cesarean section scar, two weeks apart. The researchers will perform an assessment before and after each therapeutic session, as well as 2 weeks after the last therapy (follow-up). The level of satisfaction with life (Satisfaction with Life Scale (SWLS)) as well as the area of the cesarean section scar (Vancouver Scar Scale (VSS), scar assessment according to the Mustoe classification) will be analyzed. Researchers will also assess the sequence of abdominal muscle contractions during activation of the pelvic floor muscles (ultrasound examination) and quantify the state of soft tissue tension using the MyotonPro measuring device.
- Conditions
- Cesarean Section Complications
- Being tested
- Manual therapy (myofascial release, soft tissue mobilization)
- Keywords
- Soft tissue mobilization, Scar, Cesarean section
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy (myofascial release, soft tissue mobilization)Other
Soft tissue mobilization will be performed by a team of experienced manual therapists.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Two manual therapy treatments (myofascial release, soft tissue mobilization) in the lower abdominal area and the cesarean section scar, two weeks apart. Receives: Other: Manual therapy (myofascial release, soft tissue mobilization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vancouver Scar Scale (VSS)
The Vancouver Scar Scale (VSS) rating the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contains ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing worst scar imaginable)
Measured: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
Scar assessment according to the Mustoe classification
6-stage scar classification taking into account its shape, size, color, as well as symptoms such as pain and itching.
Measured: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
Satisfaction With Life Scale (SWLS)
The Satisfaction with Life Scale (SWLS) is used to measure the feeling of satisfaction with life. This tool consists of five statements that the respondent evaluates on a seven-point scale. The respondent assesses the extent to which each statement applies to his or her life so far. The result obtained is the overall degree of satisfaction with life. The results range from 5 to 35 points. The higher the score, the higher the sense of life satisfaction.
Measured: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
Assessment of the sequence of abdominal muscle contraction during activation of the pelvic floor muscles - ultrasound examination
Sonoscape E2 device
Measured: 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
Quantitative assessment of soft tissue tension - Stiffness (S)
Objective parameter [N/m] quantifying the state of soft tissue tension using the MyotonPro device. Determines the force generated by the myometer's measuring tip needed to deform the tissue being examined to a specified depth. During the planned examination, the area of the cesarean section scar and the erector spinae muscle in the lumbar section will be assessed.
Measured: 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
Quantitative assessment of soft tissue tension - Decrement (D)
An objective parameter that quantifies the state of soft tissue tension using the MyotonPro device. It determines a property of tissue called elasticity. It is the ability of muscle tissue to return to its original shape after the deforming force ceases. During the planned examination, the area of the cesarean section scar and the erector spinae muscle in the lumbar section will be assessed.
Measured: 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
Transversus Abdominis activation-ratio (TrA-AR)
Ultrasound examination (Sonoscape E2 device): TrA activation ratio is created by dividing the thickness of the transverse abdominis muscle during contraction [mm] by the thickness of the transverse abdominis muscle during resting [mm]
Measured: 1. Before first intervention (baseline); 2 Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start24 Sep 2024
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Ożóg, Nicolaus Copernicus University
- Investigators
- Katarzyna Strojek, PhD, Study chair, Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446258
- Sponsor's protocol ID
- CMUMKscarmobilisation
- Status last verified
- May 2025
- First submitted
- 31 May 2024
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stupak A, Kondracka A, Fronczek A, Kwasniewska A. Scar Tissue after a Cesarean Section-The Management of Different Complications in Pregnant Women. Int J Environ Res Public Health. 2021 Nov 15;18(22):11998. doi: 10.3390/ijerph182211998.
PubMed 34831752Gilbert I, Gaudreault N, Gaboury I. Exploring the Effects of Standardized Soft Tissue Mobilization on the Viscoelastic Properties, Pressure Pain Thresholds, and Tactile Pressure Thresholds of the Cesarean Section Scar. J Integr Complement Med. 2022 Apr;28(4):355-362. doi: 10.1089/jicm.2021.0178. Epub 2022 Jan 13.
PubMed 35426735Li YP, Liu CL, Zhang ZJ. Feasibility of Using a Portable MyotonPRO Device to Quantify the Elastic Properties of Skeletal Muscle. Med Sci Monit. 2022 Jan 28;28:e934121. doi: 10.12659/MSM.934121.
PubMed 35087016Gilbert I, Gaudreault N, Gaboury I. Intra- and inter-evaluator reliability of the MyotonPRO for the assessment of the viscoelastic properties of caesarean section scar and unscarred skin. Skin Res Technol. 2021 May;27(3):370-375. doi: 10.1111/srt.12956. Epub 2020 Oct 21.
PubMed 33084197
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section
- ClinicalTrials.gov ID
- NCT06446258
- Acronym / sponsor ID
- CMUMKscarmobilisation
- Conditions
- Cesarean Section Complications
- Keywords
- Soft tissue mobilization, Scar, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to assess the impact of soft tissue mobilization on the scar in patients after cesarean section. An additional aim is to assess the relationship between the initial stiffness and elasticity of the scar and the age of the patients, the number of cesarean sections performed, as well as the time that has passed since the last cesarean section. Two physiotherapeutic interventions will be performed in the form of mobilization of the soft tissues (myofascial release techniques) of the lower abdominal area and the cesarean section scar, two weeks apart. The researchers will perform an assessment before and after each therapeutic session, as well as 2 weeks after the last therapy (follow-up). The level of satisfaction with life (Satisfaction with Life Scale (SWLS)) as well as the area of the cesarean section scar (Vancouver Scar Scale (VSS), scar assessment according to the Mustoe classification) will be analyzed. Researchers will also assess the sequence of abdominal muscle contractions during activation of the pelvic floor muscles (ultrasound examination) and quantify the state of soft tissue tension using the MyotonPro measuring device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Manual therapy (myofascial release, soft tissue mobilization)Two manual therapy treatments (myofascial release, soft tissue mobilization) in the lower abdominal area and the cesarean section scar, two weeks apart. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- women aged 18-45,
- undergone at least 1 cesarean section in a period of not less than 6 months,
- not using physiotherapy for a cesarean section scar
Key exclusion criteria (14 listed)
- women under 18 and over 45,
- pregnant women,
- presence of abdominal mesh,
- condition after abdominoplasty; nephrectomy; hysterectomy; cystectomy,
- uterine fibroids,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy (myofascial release, soft tissue mobilization)Soft tissue mobilization will be performed by a team of experienced manual therapists. | Other | Experimental Group |
Primary outcome
Vancouver Scar Scale (VSS)
Time frame: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
The Vancouver Scar Scale (VSS) rating the scars according to four parameters: vascularity, pigmentation, pliability, and height. Each parameter contains ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing worst scar imaginable)
Scar assessment according to the Mustoe classification
Time frame: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
6-stage scar classification taking into account its shape, size, color, as well as symptoms such as pain and itching.
Satisfaction With Life Scale (SWLS)
Time frame: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
The Satisfaction with Life Scale (SWLS) is used to measure the feeling of satisfaction with life. This tool consists of five statements that the respondent evaluates on a seven-point scale. The respondent assesses the extent to which each statement applies to his or her life so far. The result obtained is the overall degree of satisfaction with life. The results range from 5 to 35 points. The higher the score, the higher the sense of life satisfaction.
Assessment of the sequence of abdominal muscle contraction during activation of the pelvic floor muscles - ultrasound examination
Time frame: 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
Sonoscape E2 device
Quantitative assessment of soft tissue tension - Stiffness (S)
Time frame: 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
Objective parameter [N/m] quantifying the state of soft tissue tension using the MyotonPro device. Determines the force generated by the myometer's measuring tip needed to deform the tissue being examined to a specified depth. During the planned examination, the area of the cesarean section scar and the erector spinae muscle in the lumbar section will be assessed.
Quantitative assessment of soft tissue tension - Decrement (D)
Time frame: 1. Before first intervention (baseline); 2. After first intervention; 3. Before the second intervention (two weeks after the first intervention); 4. After the second intervention; 5. Two weeks after the second intervention (follow-up)
An objective parameter that quantifies the state of soft tissue tension using the MyotonPro device. It determines a property of tissue called elasticity. It is the ability of muscle tissue to return to its original shape after the deforming force ceases. During the planned examination, the area of the cesarean section scar and the erector spinae muscle in the lumbar section will be assessed.
Transversus Abdominis activation-ratio (TrA-AR)
Time frame: 1. Before first intervention (baseline); 2 Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)
Ultrasound examination (Sonoscape E2 device): TrA activation ratio is created by dividing the thickness of the transverse abdominis muscle during contraction [mm] by the thickness of the transverse abdominis muscle during resting [mm]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 34831752Stupak A, Kondracka A, Fronczek A, Kwasniewska A. Scar Tissue after a Cesarean Section-The Management of Different Complications in Pregnant Women. Int J Environ Res Public Health. 2021 Nov 15;18(22):11998. doi: 10.3390/ijerph182211998.
- Results publication: PubMed 35426735Gilbert I, Gaudreault N, Gaboury I. Exploring the Effects of Standardized Soft Tissue Mobilization on the Viscoelastic Properties, Pressure Pain Thresholds, and Tactile Pressure Thresholds of the Cesarean Section Scar. J Integr Complement Med. 2022 Apr;28(4):355-362. doi: 10.1089/jicm.2021.0178. Epub 2022 Jan 13.
- Results publication: PubMed 35087016Li YP, Liu CL, Zhang ZJ. Feasibility of Using a Portable MyotonPRO Device to Quantify the Elastic Properties of Skeletal Muscle. Med Sci Monit. 2022 Jan 28;28:e934121. doi: 10.12659/MSM.934121.
- Results publication: PubMed 33084197Gilbert I, Gaudreault N, Gaboury I. Intra- and inter-evaluator reliability of the MyotonPRO for the assessment of the viscoelastic properties of caesarean section scar and unscarred skin. Skin Res Technol. 2021 May;27(3):370-375. doi: 10.1111/srt.12956. Epub 2020 Oct 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Strojek, PhD study chair
Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy (myofascial release, soft tissue mobilization) in people with Cesarean Section Complications, run by Nicolaus Copernicus University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (VSS) (time frame: 1. Before first intervention (baseline); 2. Before the second intervention (two weeks after the first intervention); 3. Two weeks after the second intervention (follow-up)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446258, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.