Clinical trial NCT06446258: Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section
Official title: Assessment of the Impact of Soft Tissue Mobilization on the Scar in Patients After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Keywords: Soft tissue mobilization
Scar
Cesarean section
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Vancouver Scar Scale (VSS)
timeFrame: 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)
measure: Scar assessment according to the Mustoe classification
timeFrame: 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)
measure: Satisfaction With Life Scale (SWLS)
timeFrame: 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)
measure: Assessment of the sequence of abdominal muscle contraction during activation of the pelvic floor muscles - ultrasound examination
timeFrame: 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)
measure: Quantitative assessment of soft tissue tension - Stiffness (S)
timeFrame: 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)
measure: Quantitative assessment of soft tissue tension - Decrement (D)
timeFrame: 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)
measure: Transversus Abdominis activation-ratio (TrA-AR)
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University
state: Techników 3
Study officials:
affiliation: Department of Physiotherapy, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń
name: Katarzyna Strojek, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.