EFFECT OF SCAR RELEASE TECHNIQUES ON CHRONIC SCAR PAIN AND MOBILITY POST CESAREAN SECTION
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Purpose of the study: The aim of this study is to determine the effect of scar release techniques on chronic scar pain and mobility post cesarean section. Hypothesis:
- H0: There is no effect of scar release techniques on chronic scar pain and mobility post cesarean section.
- HA: There is effect of scar release techniques on chronic scar pain and mobility post cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedStudy Start
First participant enrolled
June 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedMay 26, 2022
May 1, 2022
3 months
May 21, 2022
May 21, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
pain intensity
The pain intensity will be assessed through visual analouge scale( VAS )for all participating women in both groups before and after the end of the treatment program. Each woman will be asked to mark a point on the line between the extremes that is related to her pain intensity.
up to 4 weeks
Pressure pain threshold
A pressure algometer will be used to measure pressure pain threshold (PPT)for all participating women in both groups before and after the end of the treatment program. 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 second rest between point testing. Average pressure pain threshold (AvPPPT) (pressure points across worst 3 points on scar averaged) will be used for the analysis of the PPT data
up to 4 weeks
Patient and Observer Scar Assessment Scale (POSAS)
It will be used pre and post- treatment to assess the symptoms of pain and pruritus at the cesarean section scar for all participanting women of both groups before and after the end of the treatment program.
up to 4 weeks
Scar adherence
post cesarean section scar adherence will be assessted by an adheremeter for both groups before and after the end of treatment program. 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 (MDM) . Scar mobility measurements across the points will be averaged for each participating women .
up to 4 weeks
Secondary Outcomes (1)
Quality of life
up to 4 weeks.
Study Arms (2)
therapeutic ultrasound
EXPERIMENTALControl group will be treated by therapeutic ultrasound only
therapeutic ultrasound+scar release techniques
EXPERIMENTALStudy group will be treated by various scar release techniques in addition to therapeutic ultrasound
Interventions
Control group will be treated by therapeutic ultrasound only for2 sessions per week for two weeks Study group) will be treated by various scar release techniques in addition to therapeutic ultrasound, 2 sessions per week for two weeks.
Eligibility Criteria
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 .
- 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.
- Voluntary acceptance to participate in the study.
You may not qualify if:
- Women will be excluded if they have :
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- Specialist of physical therapy at Elmansoura International hospital
Study Record Dates
First Submitted
May 21, 2022
First Posted
May 26, 2022
Study Start
June 20, 2022
Primary Completion
September 20, 2022
Study Completion
October 20, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF