Cesarean SectionNCT05979116
Effect of Abdominal Myofascial Release on Pain and Functional Outcomes of Neck in Females with Cesarean Section
A study testing myofascial release in people with Cesarean Section, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effect of abdominal myofascial release on pain, ROM and functional abilities of neck in females with CS scar. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 30 May 2024
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients suffering from chronic neck pain since more than 3 months.
- They underwent CS since at least 2 year before entry into study.
- Not suffering from neck pain before CS
- Their age will range from 20 to 35 years.
- They will be primiparous
- Body mass index (BMI) will range from 20-30 kg/m2.
Who cannot join
- Pregnancy.
- BMI over 30 kg/m2.
- Less than six months after CS.
- History of pathologies resulting in weakening of connective tissue (diabetes, neoplasms, rheumatic illnesses).
- Any abdominal surgeries other than caesarean sections.
- Any head or neck trauma.
- Skin irritation/inflammation at the site of scar.
- Any spinal deformity as kyphosis or scoliosis.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of abdominal myofascial release on pain, ROM and functional abilities of neck in females with CS scar.
Read the detailed description
irty females with neck pain will participate in this study. Subjects will receive treatment session of thirty minutes in length in order to minimize tissue irritation and avoid increased tension of the scar area, which would counter the goal of the session.
Treatment sessions will be provided biweekly for two weeks apart in order to allow physiological and biomechanical healing time between treatment sessions.
MFR techniques will be employed to release the caesarean scar and myofascia of the DFL of each subject.
The depth of the scar in this study takes us through all the layers from the skin to the uterus, following the surgical incision procedure.
MFR was the primary treatment applied to the accessible structure of the patients' DFL, through Myers's MFR techniques of DFL. MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure.
- Conditions
- Cesarean Section
- Being tested
- myofascial release
- Keywords
- cesarean section, myofascial release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial releaseOther
MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure. MFR techniques utilized with the cases include different variations of application: 1. Muscle was stroked in a long
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | this study group will receive abdominal myofascial release Receives: Other: myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain level measurement
The pain level of each subject will be assessed before participation and after the end of the treatment by using numerical rating scale. this scale have numbers from 0 to 10 with 0 means no pain at all and 10 means sever intolerable pain
Measured: 2 weeks
Scar mobility
Subjects will lay supine on a plinth with arms at their sides and legs straight. Marks were made on the CS scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar, The examiner will use the marks to measure tissue extensibility in millimeters (mm) in each of four directions: superior/left/inferior/right by using adheremeter
Measured: 2 weeks
pressure pain threshold measurement
Pressure pain threshold ( PPT) is defined as the force at which the subject asked for pressure to stop due to pain.
The pressure algometer is an instrument used to assess PPT for musculoskeletal pain. It was used to measure PPT of neck muscles before and after the treatment program for each female.
This device includes a 1 cm2 probe with a system to convert the force applied through a 1 cm2 pressure application surface to Newtons (N/cm2) or kilograms of force (kg/cm2), that appear on the display
Measured: 2 weeks
Neck ROM
Neck ROM will be measured in a standardized sitting position to remove errors and movement compensation. The subjects will be asked for sitting with their back straight. Subject's ankles, knees and hips were positioned at right angle and arms were folded across the chest to minimize thoracic movement, with tongue depressor can be held between teeth for reference.
Measured: 2 weeks
Functional disability index
The NDI is adapted from Oswestry Low Back Pain Disability Questionnaire. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Aug 2023
- Primary completion20 Feb 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- a single group study as a study that consists of only a single group of subjects included in the study design, in which all subjects received a single intervention and the outcomes are assessed over time .
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Khalil Mohamed Khalil, Cairo University
- Investigators
- Amel youssef, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979116
- Sponsor's protocol ID
- P.T.REC/012/004050
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
PubMed 28167179Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.
PubMed 18307483Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.
PubMed 32471194
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Myofascial Release on Pain and Functional Outcomes of Neck in Females with Cesarean Section
- ClinicalTrials.gov ID
- NCT05979116
- Acronym / sponsor ID
- P.T.REC/012/004050
- Conditions
- Cesarean Section
- Keywords
- cesarean section, myofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 7 Aug 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.
To investigate the effect of abdominal myofascial release on pain, ROM and functional abilities of neck in females with CS scar.
Detailed description
irty females with neck pain will participate in this study. Subjects will receive treatment session of thirty minutes in length in order to minimize tissue irritation and avoid increased tension of the scar area, which would counter the goal of the session.
Treatment sessions will be provided biweekly for two weeks apart in order to allow physiological and biomechanical healing time between treatment sessions.
MFR techniques will be employed to release the caesarean scar and myofascia of the DFL of each subject.
The depth of the scar in this study takes us through all the layers from the skin to the uterus, following the surgical incision procedure.
MFR was the primary treatment applied to the accessible structure of the patients' DFL, through Myers's MFR techniques of DFL. MFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single group study as a study that consists of only a single group of subjects included in the study design, in which all subjects received a single intervention and the outcomes are assessed over time .
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: myofascial releasethis study group will receive abdominal myofascial release |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients suffering from chronic neck pain since more than 3 months.
- They underwent CS since at least 2 year before entry into study.
- Not suffering from neck pain before CS
- Their age will range from 20 to 35 years.
- They will be primiparous
Key exclusion criteria (8 listed)
- Pregnancy.
- BMI over 30 kg/m2.
- Less than six months after CS.
- History of pathologies resulting in weakening of connective tissue (diabetes, neoplasms, rheumatic illnesses).
- Any abdominal surgeries other than caesarean sections.
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 releaseMFR in its simplest form targeted restoration of mobility of myofascial and fascial layers from within, and with the surrounding structure. MFR techniques utilized with the cases include different variations of application: 1. Muscle was stroked in a long | Other | study group |
Primary outcome
pain level measurement
Time frame: 2 weeks
The pain level of each subject will be assessed before participation and after the end of the treatment by using numerical rating scale. this scale have numbers from 0 to 10 with 0 means no pain at all and 10 means sever intolerable pain
Scar mobility
Time frame: 2 weeks
Subjects will lay supine on a plinth with arms at their sides and legs straight. Marks were made on the CS scar at 2.5 cm intervals. This resulted in from 5 to 8 measurement points along the scar, The examiner will use the marks to measure tissue extensibility in millimeters (mm) in each of four directions: superior/left/inferior/right by using adheremeter
pressure pain threshold measurement
Time frame: 2 weeks
Pressure pain threshold ( PPT) is defined as the force at which the subject asked for pressure to stop due to pain. The pressure algometer is an instrument used to assess PPT for musculoskeletal pain. It was used to measure PPT of neck muscles before and after the treatment program for each female. This device includes a 1 cm2 probe with a system to convert the force applied through a 1 cm2 pressure application surface to Newtons (N/cm2) or kilograms of force (kg/cm2), that appear on the display
Neck ROM
Time frame: 2 weeks
Neck ROM will be measured in a standardized sitting position to remove errors and movement compensation. The subjects will be asked for sitting with their back straight. Subject's ankles, knees and hips were positioned at right angle and arms were folded across the chest to minimize thoracic movement, with tongue depressor can be held between teeth for reference.
Functional disability index
Time frame: 2 weeks
The NDI is adapted from Oswestry Low Back Pain Disability Questionnaire. It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. 5 Each item is scored from 0 (no disability) to 5 (total disability).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 28167179Chamorro Comesana A, Suarez Vicente MD, Docampo Ferreira T, Perez-La Fuente Varela MD, Porto Quintans MM, Pilat A. Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study. J Bodyw Mov Ther. 2017 Jan;21(1):197-204. doi: 10.1016/j.jbmt.2016.07.003. Epub 2016 Jul 18.
- Background: PubMed 18307483Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.
- Background: PubMed 32471194Fan C, Guidolin D, Ragazzo S, Fede C, Pirri C, Gaudreault N, Porzionato A, Macchi V, De Caro R, Stecco C. Effects of Cesarean Section and Vaginal Delivery on Abdominal Muscles and Fasciae. Medicina (Kaunas). 2020 May 27;56(6):260. doi: 10.3390/medicina56060260.
- Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot studyLink provided by the sponsor.
- Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national surveyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amel youssef principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myofascial release in people with Cesarean Section, run by Cairo University at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level measurement (time frame: 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05979116, which also lists 3 linked publications.
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 19 Dec 2024.