Cesarean Section ComplicationsNCT05937217
Quality of Life and Pain Pressure Threshold in Response to Scar Release Techniques for Chronic Transverse Abdominal Scar
A study testing myofascial induction and direct scar release techniques and therapeutic ultrasound in people with Cesarean Section Complications, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- myofascial induction and direct scar release techniques and therapeutic ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Conditions
- Cesarean Section Complications
- Being tested
- myofascial induction and direct scar release techniques, therapeutic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial induction and direct scar release techniquesOther
Manual therapy techniques used to reduce chronic lower transverse abdominal scars pain and improve quality of life of the affected women
therapeutic ultrasoundDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
Measured: 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.
Measured: within 4 weeks
Secondary outcomes (1)
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.
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start5 Jul 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manal ahmed el-shafei mohamed, Cairo University
- Investigators
- Manal M El-shafei, PHD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937217
- Sponsor's protocol ID
- P.T.REC/012/004580
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05937217
- Acronym / sponsor ID
- P.T.REC/012/004580
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myofascial induction and direct scar release techniques group | Experimental | Other: myofascial induction and direct scar release techniques, Device: therapeutic ultrasoundThey 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. |
| therapeutic ultrasound group | Experimental | Device: therapeutic ultrasoundThey will receive a therapeutic ultrasound, 2 sessions per week for two weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myofascial induction and direct scar release techniquesManual therapy techniques used to reduce chronic lower transverse abdominal scars pain and improve quality of life of the affected women | Other | myofascial induction and direct scar release techniques group |
| therapeutic ultrasoundUltrasound 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 | Device | myofascial induction and direct scar release techniques group, therapeutic ultrasound group |
Primary outcome
Pain pressure threshold (PPT)
Time frame: within 4 weeks
* 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 .
scar mobility
Time frame: within 4 weeks
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
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: within 4 weeks
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.
1 secondary outcome
quality of life assessment
Time frame: within 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manal M El-shafei, PHD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing myofascial induction and direct scar release techniques and therapeutic ultrasound in people with Cesarean Section Complications, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal El- shafei, PHD (01220664518, manal.ahmed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (PPT) (time frame: within 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.