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

NCT06446258 | Completed

• 1 other identifier: CMUMKscarmobilisation
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Soft tissue mobilization; Scar; Cesarean section

Outcome Measures

Primary Outcomes (7)

• 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)

  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.

  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.

  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

  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.

  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.

  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 \[mm\]

  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)

Study Arms (1)

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.

Other: Manual therapy (myofascial release, soft tissue mobilization)

Interventions

Manual therapy (myofascial release, soft tissue mobilization) OTHER

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

Experimental Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Study Sites (1)

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

Bydgoszcz, Techników 3, 85-801, Poland

Location

Related Publications (4)

• 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.

  PMID: 34831752 BACKGROUND

• Gilbert 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.

  PMID: 35426735 RESULT

• Li 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.

  PMID: 35087016 RESULT

• Gilbert 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.

  PMID: 33084197 RESULT

MeSH Terms

Conditions

Cicatrix

Interventions

Musculoskeletal Manipulations; Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Massage; Therapy, Soft Tissue

Study Officials

• Katarzyna Strojek, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: September 24, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

PL (1)