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

NCT05937217 | Unknown

• 1 other identifier: P.T.REC/012/004580
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cesarean Section Complications

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• quality of life assessment

  within 4 weeks

Study Arms (2)

myofascial induction and direct scar release techniques group

EXPERIMENTAL

They will receive myofascial induction therapy in the form of transverse sliding and cross hand therapy and direct scar release techniques in the form of stroking, circular movement, vertical point lifting , C and S grip techniques, and therapeutic ultrasound, 2 sessions per week for two weeks.

Other: myofascial induction and direct scar release techniques; Device: therapeutic ultrasound

therapeutic ultrasound group

EXPERIMENTAL

They will receive a therapeutic ultrasound, 2 sessions per week for two weeks.

Device: therapeutic ultrasound

Interventions

therapeutic ultrasound DEVICE

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

myofascial induction and direct scar release techniques group; therapeutic ultrasound group

myofascial induction and direct scar release techniques OTHER

Manual therapy techniques used to reduce chronic lower transverse abdominal scars pain and improve quality of life of the affected women

myofascial induction and direct scar release techniques group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Ultrasonic Therapy

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Manal M El-shafei, PHD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal El- shafei, PHD

CONTACT

01220664518; manal.ahmed@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy for women's health , faculty of physical therapy

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: July 5, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF