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US vs. LASER on Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis

Primary Purpose

Neurotmesis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
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.
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurotmesis focused on measuring iliohypogastric neurotmesis, post cesarean, low level laser, low intensity pulsed ultrasound

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Multiparous

BMI > 30

Diabetic patients

Smokers

Patients take vitamin B complex

Any previous incision in hypogastric region

Sites / Locations

  • Faculty of physical therapy, South Valley University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

low intensity pulsed ultrasound

low level laser therapy

static abdominal and pelvic floor exercises

Arm Description

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.

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.

20 women were the control group who received only static abdominal and pelvic floor exercises. , 3 times/week for 4 weeks.

Outcomes

Primary Outcome Measures

Iliohypogastric nerve injury and recovery
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
Iliohypogastric nerve injury and recovery
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively

Secondary Outcome Measures

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)
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)

Full Information

First Posted
September 9, 2020
Last Updated
September 25, 2021
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT04556409
Brief Title
US vs. LASER on Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
Official Title
Low Intensity Pulsed Ultrasound Therapy Versus Low Level LASER Therapy in the Treatment of Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotmesis
Keywords
iliohypogastric neurotmesis, post cesarean, low level laser, low intensity pulsed ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low intensity pulsed ultrasound
Arm Type
Experimental
Arm Description
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.
Arm Title
low level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
static abdominal and pelvic floor exercises
Arm Type
Placebo Comparator
Arm Description
20 women were the control group who received only static abdominal and pelvic floor exercises. , 3 times/week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
low level LASER plus static abdominal and pelvic floor exercises.
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
static abdominal and pelvic floor exercises only.
Intervention Description
static abdominal and pelvic floor exercises., 3 times/week for 4 weeks.
Primary Outcome Measure Information:
Title
Iliohypogastric nerve injury and recovery
Description
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
Time Frame
before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.
Title
Iliohypogastric nerve injury and recovery
Description
Ultrasonography was used to assess Iliohypogastric nerve injury (pretreatment) and recovery (post treatment) objectively
Time Frame
After last session (after end of the treatment) through one week from last session.
Secondary Outcome Measure Information:
Title
sensory function of ilihypogastric nerve
Description
Erasmus MC version of the Nottingham Sensory Assessment was used to assess sensory function of ilihypogastric nerve (pretreatment and posttreatment)
Time Frame
before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.
Title
sensory function of ilihypogastric nerve
Description
Erasmus MC version of the Nottingham Sensory Assessment was used to assess sensory function of ilihypogastric nerve (pretreatment and posttreatment)
Time Frame
After last session (after end of the treatment) through one week from last session.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
post cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Multiparous BMI > 30 Diabetic patients Smokers Patients take vitamin B complex Any previous incision in hypogastric region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed GA Ali
Phone
+201014397608
Email
dr_m.gamal1987@svu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab SA Mamoon
Phone
+201001441982
Email
rehabsaber35@svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed GA Ali, Msc
Organizational Affiliation
Assistant lecturer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rehab SA Mamoon, Msc
Organizational Affiliation
Assistant lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of physical therapy, South Valley University
City
Qinā
State/Province
Qena
ZIP/Postal Code
83511
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed GA Ali, Msc
Phone
01014397608
Email
dr_m.gamal1987@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

US vs. LASER on Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis

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