Low Intensity Pulsed Ultrasound Therapy Versus Low Level LASER Therapy in the Treatment of Post Cesarean Anterior Cutaneous Branches of Iliohypogastric Neurotmesis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- South Valley University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Iliohypogastric nerve injury and recovery
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Exclusion Criteria
- •Multiparous
- •Diabetic patients
- •Patients take vitamin B complex
- •Any previous incision in hypogastric region
Arms & Interventions
low intensity pulsed ultrasound
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.
Intervention: low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises. (Device)
low intensity pulsed ultrasound
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.
Intervention: static abdominal and pelvic floor exercises only. (Other)
low level laser therapy
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.
Intervention: low level LASER plus static abdominal and pelvic floor exercises. (Device)
low level laser therapy
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.
Intervention: static abdominal and pelvic floor exercises only. (Other)
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.
Intervention: static abdominal and pelvic floor exercises only. (Other)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- sensory function of ilihypogastric nerve(After last session (after end of the treatment) through one week from last session.)
- sensory function of ilihypogastric nerve(before beginning in the treatment (before the first session) through assessment session the day before beginning the treatment.)
Investigators
Mohamed Gamal Abouelyazeed Ali
Principal investigator
South Valley University