Quality of Life and Pain Pressure Threshold in Response to Scar Release Techniques for Chronic Transverse Abdominal Scar

Cesarean Section Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05937217
• Other study ID #: P.T.REC/012/004580
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Manal El- shafei, PHD
• Phone: 01220664518
• Email: manal.ahmed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Other:
• myofascial induction and direct scar release techniques
Manual therapy techniques used to reduce chronic lower transverse abdominal scars pain and improve quality of life of the affected women

Device:
• therapeutic ultrasound
Ultrasound petron (model SM 500) specifications: output frequency:1Mhz, output power:5W/cm², power intensity:5 degree (0.8-1.2-1.6-2.0-2.5), time intensity:5-30(step by 5 min) . It will be applied for both groups for 10 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain pressure threshold (PPT)	A pressure algometer will be used to measure pressure pain threshold for all participating women in both groups. ?; PPT recording sites will be marked on the C-section scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar.; Following, the marked points will be used to record PPTs in all time points for the PPT assessment; a 1-cm2 pressure probe will be positioned perpendicularly to the skin and pressed at a rate of 30kPa/s.Two measures will be collected for each area, with 30 seconds rest between point testing .; Average pressure pain threshold (pressure points across worst 3 points on scar averaged) will be used to analyze the PPT data .	within 4 weeks
Primary	scar mobility	lower transverse abdominal scar mobility will be assessted by an adheremeter for both groups (A and B)before and after the end of treatment program.; The adheremeter as described by Ferriero et al. has a radius of approximately 1.75 cm with concentric circles 2 mm apart . A mark will be made on the tightest part of the scar in four directions (superior, inferior, right and left). As there is no a contralateral side to abdominal tissue to be used as a reference range, we will use multi-directional scar mobility. Scar mobility measurements across the points will be averaged for each participating women and will be performed at the initial evaluation after 2 weeks (the end of the treatment) and at fourth week as follow up	within 4 weeks
Primary	Patient and Observer Scar Assessment Scale (POSAS)	It includes subjective symptoms of pain and pruritus. It consists of 2 numerical numeric scales,it assesses vascularity, pigmentation, thickness, relief, pliability, and surface area, and it incorporates patient assessments of pain, itching, color, stiffness, thickness, and relief . The observer scar assessment scale rated five variables, each variable used a 10-point scoring system, summed to obtain a total score ranging from 5 to 50, with 5 representing normal skin with no associated symptoms. The patient scar assessment scale consisted of six items on scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item used a 10-point scoring system, summed to obtain a total score ranging from 6 to 60, with 6 representing normal skin with no associated symptoms.	within 4 weeks
Secondary	quality of life assessment	Short form 36 (SF-36) questionnaire will be used to assess the health-related quality of life .for all women in both groups (A and B)before and after the end of the treatment program.; It measures health on eight multi-item dimensions, covering functional status, well-being, and overall health evaluation, each associated with 2-10 possible answers. The answer to each question is extrapolated to a standardized set of answers, and the results are transferred to a scale of 0-100, where 0 represents the worst state of health, and 100 represents the best state of health measured.	within 4 weeks