Cesarean Section ComplicationsNCT05391685
EFFECT OF SCAR RELEASE TECHNIQUES ON CHRONIC SCAR PAIN AND MOBILITY POST CESAREAN SECTION
A study testing Scar release techniques + therapeutic ultrasound in people with Cesarean Section Complications, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Scar release techniques + therapeutic ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2022to 20 Oct 2022
- 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
- No healthy volunteers
- 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 .
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
A vicious impediment on quality of life including psychological and functional disability, and interference with baby care and bonding may occur among women who experience chronic post-caesarean section pain (CPCSP) .
Structural alterations of the skin and subcutaneous tissues with scarring result in reduced mobility and viscoelasticity that could cause compression of the sensory receptors and nerve fibers and disrupt their signaling. The viscoelastic properties could potentially be modified when the skin and scars are stressed and/or strained by manual therapies and this can affect the sensitivity threshold of the mechanosensitive and nociceptive receptors.
There are limited studies about the effect of various scar release techniques on chronic post cesarean section scar pain and mobility and their impact on quality of life on the affected women . So, this study will be helpful and of valuable benefits for medical services organizations and increase body of knowledge of physical therapists in scientific field.
This study will be conducted on forty women suffering from chronic post cesarean section scar pain and restricted scar mobility , they will be referred from department of Obestetrics and Gynaecology in Elmansoura International Hospital, Egypt.
- Conditions
- Cesarean Section Complications
- Being tested
- Scar release techniques + therapeutic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar release techniques + therapeutic ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| therapeutic ultrasound | Experimental | Control group will be treated by therapeutic ultrasound only Receives: Other: Scar release techniques + therapeutic ultrasound |
| therapeutic ultrasound+scar release techniques | Experimental | Study group will be treated by various scar release techniques in addition to therapeutic ultrasound Receives: Other: Scar release techniques + therapeutic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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 .
Measured: up to 4 weeks
Secondary outcomes (1)
Quality of life
SF-36 questionnaire will be used to assess the health related quality of life for all women in both groups before and after the end of the treatment program.
Measured: up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start20 Jun 2022 (estimated)
- Primary completion20 Sep 2022 (estimated)
- Study completion20 Oct 2022 (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, Nabiha Mahmoud Ahmed Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391685
- Sponsor's protocol ID
- P.T.REC/012/003710
- Status last verified
- May 2022
- First submitted
- 21 May 2022
- Last updated
- 26 May 2022
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF SCAR RELEASE TECHNIQUES ON CHRONIC SCAR PAIN AND MOBILITY POST CESAREAN SECTION
- ClinicalTrials.gov ID
- NCT05391685
- Acronym / sponsor ID
- P.T.REC/012/003710
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 20 Sep 2022 (estimated)
- Study completion
- 20 Oct 2022 (estimated)
- First posted
- 26 May 2022 (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.
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.
Detailed description
A vicious impediment on quality of life including psychological and functional disability, and interference with baby care and bonding may occur among women who experience chronic post-caesarean section pain (CPCSP) .
Structural alterations of the skin and subcutaneous tissues with scarring result in reduced mobility and viscoelasticity that could cause compression of the sensory receptors and nerve fibers and disrupt their signaling. The viscoelastic properties could potentially be modified when the skin and scars are stressed and/or strained by manual therapies and this can affect the sensitivity threshold of the mechanosensitive and nociceptive receptors.
There are limited studies about the effect of various scar release techniques on chronic post cesarean section scar pain and mobility and their impact on quality of life on the affected women . So, this study will be helpful and of valuable benefits for medical services organizations and increase body of knowledge of physical therapists in scientific field.
This study will be conducted on forty women suffering from chronic post cesarean section scar pain and restricted scar mobility , they will be referred from department of Obestetrics and Gynaecology in Elmansoura International Hospital, Egypt.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapeutic ultrasound | Experimental | Other: Scar release techniques + therapeutic ultrasoundControl group will be treated by therapeutic ultrasound only |
| therapeutic ultrasound+scar release techniques | Experimental | Other: Scar release techniques + therapeutic ultrasoundStudy group will be treated by various scar release techniques in addition to therapeutic ultrasound |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 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 .
- 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 (7 listed)
- 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.
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 |
|---|---|---|
| Scar release techniques + therapeutic ultrasoundControl 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. | Other | therapeutic ultrasound, therapeutic ultrasound+scar release techniques |
Primary outcome
pain intensity
Time frame: up to 4 weeks
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.
Pressure pain threshold
Time frame: up to 4 weeks
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
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: up to 4 weeks
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.
Scar adherence
Time frame: up to 4 weeks
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 .
1 secondary outcome
Quality of life
Time frame: up to 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Section Complications
Not yet recruiting
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
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Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Questions about this trial
What is this clinical trial studying?
A study testing Scar release techniques + 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 6 inclusion and 7 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 26 May 2022. 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 Ahmed, lecturer (01220664518, manalpt1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to 4 weeks). The study lists 4 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 26 May 2022.