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Completed

NCT Number: NCT06446258

Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section

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.

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Key information

Conditions

Cesarean Section Complications Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University

Bydgoszcz, Techników 3, 85-801, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • women under 18 and over 45,
  • pregnant women,
  • presence of abdominal mesh,
  • condition after abdominoplasty; nephrectomy; hysterectomy; cystectomy,
  • uterine fibroids,
  • stoma,
  • 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

Treatment and study plan

Manual therapy (myofascial release, soft tissue mobilization)

Other

Soft tissue mobilization will be performed by a team of experienced manual therapists.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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]

Sponsors and collaborators

Lead sponsor

Nicolaus Copernicus University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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