NeurotmesisNCT04556409
US vs. LASER on Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
A study testing low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises., low level LASER plus static abdominal and pelvic floor exercises. and static abdominal and pelvic floor exercises only. in people with Neurotmesis, run by South Valley University at 1 site in Egypt.
Trial summary
the aim of this study is to compare the effect of low intensity pulsed ultrasound therapy and the effect of low level LASER in the treatment of post cesarean anterior cutaneous branches of iliohypogastric neurotmesis. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neurotmesis
- What is being tested?
- low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises., low level LASER plus static abdominal and pelvic floor exercises. and static abdominal and pelvic floor exercises only.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 30 Dec 2021
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All females were clinically diagnosed with post caesarean anterior cutaneous branches of iliohypogastric neurotmesis by an Obstetrician.
- Their ages were ranged from 18 to 35 years old,
- All patients participated after removal of surgical stitches (after 2 weeks of cesarean delivery),
- All patients were primiparous,
- All patients were non-diabetic and all patients received relaxation training.
- BMI < 30
Who cannot join
- Multiparous
- BMI > 30
- Diabetic patients
- Smokers
- Patients take vitamin B complex
- Any previous incision in hypogastric region
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy, South Valley University
Qina, Qena Governorate, 83511
Mohamed GA Ali, Msc, 01014397608, dr_m.gamal1987@yahoo.com
About this study
Official title: Low Intensity Pulsed Ultrasound Therapy Versus Low Level LASER Therapy in the Treatment of Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
the aim of this study is to compare the effect of low intensity pulsed ultrasound therapy and the effect of low level LASER in the treatment of post cesarean anterior cutaneous branches of iliohypogastric neurotmesis.
Read the detailed description
Cesarean section is one of the commonly performed surgical procedures in obstetrics and is certainly one of the oldest operations in surgery. One of the most dramatic features of modern obstetrics is the increase in the caesarean section rate. In Egypt, the past decade has witnessed a sharp increase in the prevalence of CS with the most recent Egypt Demographic and Health Survey (EDHS) documenting a CS rate of 52%, which suggests that caesarean delivery might be overused or used for inappropriate indications.
Several CS skin incision and abdominal wall opening techniques have been developed during the years, yet a general consensus on the most appropriate approach, in terms of safety and morbidity has not been yet reached 3.The choice of technique depends largely on the Surgeon's experience and preference and on the maternal-fetal clinical condition .
The Pfannenstiel incision and the Misgav-Ladach method, mainly represented by the modified Joel-Cohen incision, are the most common skin incisions performed . The Pfannenstiel incision is a transverse "smile"-like incision made 2-3 cm above the symphysis pubis at the pubic area border; the Misgav-Ladach method is a straight transverse skin incision which lies about 3 cm below the level of the anterior superior iliac spines (ASIS) . Both techniques involve skin and subcutaneous tissues . Although several studies comparing these two abdominal wall opening techniques have been conducted, differences in terms of acute and chronic post-operative pain have not been always considered .
Acute and chronic pain after CS depends mainly on the type of cutaneous incision and subsequent access into the pelvic cavity, in relation to the abdominal wall's somatic innervation .
Both techniques involve an abdominal area innervated by two principal nerves: ileo-hypogastric and ileo-inguinal. These nerves originate from the lumbar plexus, which is formed by the ventral branches of the first to the fourth lumbar nerves (L1-L4) and by the last thoracic nerve (T12) supplementing with a twig .
The iliohypogastric nerve is formed by the fusion of the first lumbar branch with fibers originating from T12. It arises from the upper part of the lateral border of the psoas major then courses infra-laterally atop the quadratus lumborum to the ilium crest where it pierces the transverse abdominal muscle and emerges approximately 3 cm medial to the ASIS. The proximal end of the iliohypogastric nerve enters the abdominal wall 2.8±1.3 cm medial to and 1.4±1.2 cm inferior to the ASIS. Once in the abdominal wall, it follows a linear path terminating 4±1.3 cm lateral to the midline . As the iliohypogastric passes through the abdominal oblique muscles, it divides into the lateral and anterior cutaneous branches which provide sensory innervation to the gluteal (lateral cutaneous branch) and the hypogastric skin regions (anterior cutaneous branch).
For the treatment of peripheral nerve injury, low energy biostimulation lasers are used, applied in the way of pulsatile (905 nm), continuous (808 nm), or pulsing-constant rays. Laser therapy increases the formation of ATP, and the energy of the ATP hydrolysis can be used by nerve cell to restore normal transmembrane potential, which facilitates the generation of electrical impulses and thereby restoring nerve conduction (bioelectric effect). Application of laser beams improves microcirculation and hence nutrition and regeneration of nerve cells - bio-stimulation effect - and increases the release of endorphins and the concentration of neurotransmitters in the synapses - analgetic effect. Application of laser irradiation (Ga-As laser) in the site of the anastomosis inhibits the degeneration process, accelerate remyelination, and nerve function recovery . In the clinic, low-level laser therapy employs doses from 1 to 4J/cm2, associated with output power between 10 to 90mW, and is widely used in various musculoskeletal lesions, as well as in painful and inflammatory processes .
In a precious study had done by Lowdon and Colleagues 30,they found that continous ultrasound at low intensity (0.5W/cm2, 1MHZ, 1min. day every day for 2-3 weeks) was beneficial for regeneration of tibial nerve of rats following compression lesion while continous ultrasound at high intensity (1W/cm2, 1MHZ, 1min. day every day for 2-3 weeks) was harmful for regeneration of tibial nerve of rats following compression injury.
Continous low intensity ultrasound (CLIU) treatment can accelerate the regeneration and functional recovery of neurotometic injured sciatic nerve at earlier stages after injury, the upgraded expression of NGF induced by continuous low intensity ultrasound may be the primary mechanism of the acceleration effects .
- Conditions
- Neurotmesis
- Being tested
- low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises., low level LASER plus static abdominal and pelvic floor exercises., static abdominal and pelvic floor exercises only.
- Keywords
- iliohypogastric neurotmesis, post cesarean, low level laser, low intensity pulsed ultrasound
- Medical subject headings
- Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises.Device
Ultrasonic irradiation was employed with parameters of current use in clinical practice, including lower potency (0.16 W/cm2), which is more adequate for stimulation of nerve regeneration, according to results obtained in investigations in which the irradiation was applied at the lesion site 32, 33.
low level LASER plus static abdominal and pelvic floor exercises.Device
Application of laser irradiation (Ga-As laser) in the site of the anastomosis inhibits the degeneration process, accelerate remyelination, and nerve function recovery 27, 28
static abdominal and pelvic floor exercises only.Other
static abdominal and pelvic floor exercises., 3 times/week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| low intensity pulsed ultrasound | Experimental | 20 women were treated by low intensity pulsed ultrasound (5 min, 0.5 w/cm2, 1MHZ with 20% duty cycle, 3 times/ week for 4 weeks plus static abdominal and pelvic floor exercises. Receives: Device: low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises.; Other: static abdominal and pelvic floor exercises only. |
| low level laser therapy | Experimental | 20 women were treated by low level laser therapy (Gallium Aluminum Arsenide Laser), 808nm, 4J/cm2, pulsating signal, 60 seconds for each point, 30 Mw/cm2, 3 times/week for 4 weeks plus static abdominal and pelvic floor exercises. Receives: Device: low level LASER plus static abdominal and pelvic floor exercises.; Other: static abdominal and pelvic floor exercises only. |
| static abdominal and pelvic floor exercises | Placebo comparator | 20 women were the control group who received only static abdominal and pelvic floor exercises. , 3 times/week for 4 weeks. Receives: Other: static abdominal and pelvic floor exercises only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iliohypogastric nerve injury and recovery
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
Measured: before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.
Iliohypogastric nerve injury and recovery
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
Measured: After last session (after end of the treatment) through one week from last session.
Secondary outcomes (2)
sensory function of ilihypogastric nerve
Erasmus MC version of the Nottingham Sensory Assessment was used to assess sensory function of ilihypogastric nerve (pretreatment and posttreatment)
Measured: before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.
sensory function of ilihypogastric nerve
Erasmus MC version of the Nottingham Sensory Assessment was used to assess sensory function of ilihypogastric nerve (pretreatment and posttreatment)
Measured: After last session (after end of the treatment) through one week from last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Nov 2021 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotmesisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Abouelyazeed Ali, South Valley University
- Investigators
- Mohamed GA Ali, Msc, Principal investigator, Assistant lecturerRehab SA Mamoon, Msc, Study director, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556409
- Sponsor's protocol ID
- Post CS numbness
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Intensity Pulsed Ultrasound Therapy Versus Low Level LASER Therapy in the Treatment of Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
- ClinicalTrials.gov ID
- NCT04556409
- Acronym / sponsor ID
- Post CS numbness
- Conditions
- Neurotmesis
- Keywords
- iliohypogastric neurotmesis, post cesarean, low level laser, low intensity pulsed ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 21 Sep 2020 (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.
the aim of this study is to compare the effect of low intensity pulsed ultrasound therapy and the effect of low level LASER in the treatment of post cesarean anterior cutaneous branches of iliohypogastric neurotmesis.
Detailed description
Cesarean section is one of the commonly performed surgical procedures in obstetrics and is certainly one of the oldest operations in surgery. One of the most dramatic features of modern obstetrics is the increase in the caesarean section rate. In Egypt, the past decade has witnessed a sharp increase in the prevalence of CS with the most recent Egypt Demographic and Health Survey (EDHS) documenting a CS rate of 52%, which suggests that caesarean delivery might be overused or used for inappropriate indications.
Several CS skin incision and abdominal wall opening techniques have been developed during the years, yet a general consensus on the most appropriate approach, in terms of safety and morbidity has not been yet reached 3.The choice of technique depends largely on the Surgeon's experience and preference and on the maternal-fetal clinical condition .
The Pfannenstiel incision and the Misgav-Ladach method, mainly represented by the modified Joel-Cohen incision, are the most common skin incisions performed . The Pfannenstiel incision is a transverse "smile"-like incision made 2-3 cm above the symphysis pubis at the pubic area border; the Misgav-Ladach method is a straight transverse skin incision which lies about 3 cm below the level of the anterior superior iliac spines (ASIS) . Both techniques involve skin and subcutaneous tissues . Although several studies comparing these two abdominal wall opening techniques have been conducted, differences in terms of acute and chronic post-operative pain have not been always considered .
Acute and chronic pain after CS depends mainly on the type of cutaneous incision and subsequent access into the pelvic cavity, in relation to the abdominal wall's somatic innervation .
Both techniques involve an abdominal area innervated by two principal nerves: ileo-hypogastric and ileo-inguinal. These nerves originate from the lumbar plexus, which is formed by the ventral branches of the first to the fourth lumbar nerves (L1-L4) and by the last thoracic nerve (T12) supplementing with a twig .
The iliohypogastric nerve is formed by the fusion of the first lumbar branch with fibers originating from T12. It arises from the upper part of the lateral border of the psoas major then courses infra-laterally atop the quadratus lumborum to the ilium crest where it pierces the transverse abdominal muscle and emerges approximately 3 cm medial to the ASIS. The proximal end of the iliohypogastric nerve enters the abdominal wall 2.8±1.3 cm medial to and 1.4±1.2 cm inferior to the ASIS. Once in the abdominal wall, it follows a linear path terminating 4±1.3 cm lateral to the midline . As the iliohypogastric passes through the abdominal oblique muscles, it divides into the lateral and anterior cutaneous branches which provide sensory innervation to the gluteal (lateral cutaneous branch) and the hypogastric skin regions (anterior cutaneous branch).
For the treatment of peripheral nerve injury, low energy biostimulation lasers are used, applied in the way of pulsatile (905 nm), continuous (808 nm), or pulsing-constant rays. Laser therapy increases the formation of ATP, and the energy of the ATP hydrolysis can be used by nerve cell to restore normal transmembrane potential, which facilitates the generation of electrical impulses and thereby restoring nerve conduction (bioelectric effect). Application of laser beams improves microcirculation and hence nutrition and regeneration of nerve cells - bio-stimulation effect - and increases the release of endorphins and the concentration of neurotransmitters in the synapses - analgetic effect. Application of laser irradiation (Ga-As laser) in the site of the anastomosis inhibits the degeneration process, accelerate remyelination, and nerve function recovery . In the clinic, low-level laser therapy employs doses from 1 to 4J/cm2, associated with output power between 10 to 90mW, and is widely used in various musculoskeletal lesions, as well as in painful and inflammatory processes .
In a precious study had done by Lowdon and Colleagues 30,they found that continous ultrasound at low intensity (0.5W/cm2, 1MHZ, 1min. day every day for 2-3 weeks) was beneficial for regeneration of tibial nerve of rats following compression lesion while continous ultrasound at high intensity (1W/cm2, 1MHZ, 1min. day every day for 2-3 weeks) was harmful for regeneration of tibial nerve of rats following compression injury.
Continous low intensity ultrasound (CLIU) treatment can accelerate the regeneration and functional recovery of neurotometic injured sciatic nerve at earlier stages after injury, the upgraded expression of NGF induced by continuous low intensity ultrasound may be the primary mechanism of the acceleration effects .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low intensity pulsed ultrasound | Experimental | Device: low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises., Other: static abdominal and pelvic floor exercises only.20 women were treated by low intensity pulsed ultrasound (5 min, 0.5 w/cm2, 1MHZ with 20% duty cycle, 3 times/ week for 4 weeks plus static abdominal and pelvic floor exercises. |
| low level laser therapy | Experimental | Device: low level LASER plus static abdominal and pelvic floor exercises., Other: static abdominal and pelvic floor exercises only.20 women were treated by low level laser therapy (Gallium Aluminum Arsenide Laser), 808nm, 4J/cm2, pulsating signal, 60 seconds for each point, 30 Mw/cm2, 3 times/week for 4 weeks plus static abdominal and pelvic floor exercises. |
| static abdominal and pelvic floor exercises | Placebo comparator | Other: static abdominal and pelvic floor exercises only.20 women were the control group who received only static abdominal and pelvic floor exercises. , 3 times/week for 4 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All females were clinically diagnosed with post caesarean anterior cutaneous branches of iliohypogastric neurotmesis by an Obstetrician.
- Their ages were ranged from 18 to 35 years old,
- All patients participated after removal of surgical stitches (after 2 weeks of cesarean delivery),
- All patients were primiparous,
- All patients were non-diabetic and all patients received relaxation training.
Key exclusion criteria (6 listed)
- Multiparous
- BMI > 30
- Diabetic patients
- Smokers
- Patients take vitamin B complex
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 |
|---|---|---|
| low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises.Ultrasonic irradiation was employed with parameters of current use in clinical practice, including lower potency (0.16 W/cm2), which is more adequate for stimulation of nerve regeneration, according to results obtained in investigations in which the irradiation was applied at the lesion site 32, 33. | Device | low intensity pulsed ultrasound |
| low level LASER plus static abdominal and pelvic floor exercises.Application of laser irradiation (Ga-As laser) in the site of the anastomosis inhibits the degeneration process, accelerate remyelination, and nerve function recovery 27, 28 | Device | low level laser therapy |
| static abdominal and pelvic floor exercises only.static abdominal and pelvic floor exercises., 3 times/week for 4 weeks. | Other | low intensity pulsed ultrasound, low level laser therapy, static abdominal and pelvic floor exercises |
Primary outcome
Iliohypogastric nerve injury and recovery
Time frame: before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
Iliohypogastric nerve injury and recovery
Time frame: After last session (after end of the treatment) through one week from last session.
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
2 secondary outcomes
sensory function of ilihypogastric nerve
Time frame: before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.
sensory function of ilihypogastric nerve
Time frame: After last session (after end of the treatment) through one week from last session.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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.
Mohamed GA Ali, Msc principal investigator
Assistant lecturer
Rehab SA Mamoon, Msc study director
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises., low level LASER plus static abdominal and pelvic floor exercises. and static abdominal and pelvic floor exercises only. in people with Neurotmesis, run by South Valley 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 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 28 Sep 2021. 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. Some participants in this study may receive a placebo. 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 Mohamed GA Ali (+201014397608, dr_m.gamal1987@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iliohypogastric nerve injury and recovery (time frame: before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.). The study lists 2 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 28 Sep 2021.