Clinical trial NCT05937217: Quality of Life and Pain Pressure Threshold in Response to Scar Release Techniques for Chronic Transverse Abdominal Scar
Official title: Quality of Life and Pain Pressure Threshold in Response to Myofascial Induction Therapy and Direct Scar Release Techniques for Chronic Lower Transverse Abdominal Scar
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative scarring is one of the most common concerns among surgical patients. The incidence of abnormal scarring, i.e. keloid or hypertrophic scar formation after caesarean section (CS) is reported to be 41% .That can lead to functional limitations, pruritus, pain and cosmetic issues. so, the purpose of this study is to investigate quality of life and pain pressure threshold in response to myofascial induction and direct scar release techniques for lower transverse abdominal scar

Detailed description: This study will be conducted on forty women with chronic lower transvers abdominal scar , they will be referred from department of Obstetrics and Gynecology ,Kasr Eleiny teaching Hospital and outpatient clinic of faculty of physical therapy, cairo university, Egypt.

All women will be randomly divided into two equal groups:

* Group A(Study group):It will include 20 women who will be treated by myofascial induction and direct scar release techniques in addition to therapeutic ultrasound, 2 sessions per week for two weeks.
* Group B(Control group):It will include 20 women who will be treated by therapeutic ultrasound, 2 sessions per week for two weeks.

Eligibility criteria: Inclusion Criteria:

* Women with a well healed, old , transverse cesarean section scar (more than 6 months resulted in chronic scar pain).
* Pain can be intermittent or constant at rest or with activity, and it is reported to be at least at a level of about 3/ 10 on visual analogue scale at recording sites will be marked on the C-section scar at 2.5 cm intervals (Wasserman et al., 2018).
* Women identified that the pain is either located in the cesarean section scar or caused by palpation of scar and it presents since the time of surgery not prior to the cesarean section.
* Their ages will range from 25-35 years old.
* Their BMI will be 18.5-29.9 kg/ m².

Exclusion Criteria:

* Acute and subacute cesarean section.
* Delayed wound healing.
* History of abdominal or pelvic cancer.
* Active pelvic or abdominal infection.
* Skin irritation/inflammation at the site of scar.
* Currently pregnant women.

Primary outcomes:
measure: Pain pressure threshold (PPT)
timeFrame: within 4 weeks
measure: scar mobility
timeFrame: within 4 weeks
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: within 4 weeks
Secondary outcomes:
measure: quality of life assessment
timeFrame: within 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Manal M El-shafei, PHD
role: PRINCIPAL_INVESTIGATOR
References: