Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04556409
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-09-09
Brief Title:
US vs LASER on Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
Sponsor:
South Valley University
Organization:
South Valley University
Study Overview
Official Title:
Low Intensity Pulsed Ultrasound Therapy Versus Low Level LASER Therapy in the Treatment of Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 3The choice of technique depends largely on the Surgeons 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 walls 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 2813 cm medial to and 1412 cm inferior to the ASIS Once in the abdominal wall it follows a linear path terminating 413 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 4Jcm2 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 30they found that continous ultrasound at low intensity 05Wcm2 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 1Wcm2 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
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 3The choice of technique depends largely on the Surgeons 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 walls 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 2813 cm medial to and 1412 cm inferior to the ASIS Once in the abdominal wall it follows a linear path terminating 413 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 4Jcm2 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 30they found that continous ultrasound at low intensity 05Wcm2 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 1Wcm2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None