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Clinical Trials/NCT06262490
NCT06262490CompletedNot Applicable

Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain

Cairo University1 site in 1 country40 target enrollmentStarted: March 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Assessment of osteomyoarticular symptoms

Study Overview

Brief Summary

The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms .

Detailed Description

Chronic perineal pain is the anorectal and perineal pain without underlying organic disease, anorectal or endopelvic, which has been excluded by careful physical examination, radiological and endoscopic investigations. So, perineal and vaginal pain after vaginal delivery has been associated with tissue trauma related to operative vaginal delivery, perineal laceration, and episiotomy.

Studies assessing chronic pain after vaginal delivery report 2% to 10% of women with pain at six months and later, almost exclusively in mothers who had an assisted vaginal birth. Postpartum pain intensity is usually higher when it is related to vaginal delivery than to cesarean delivery and more severely affects the woman's quality of life and mood.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The age of the subjects will be ranged from 20 to 35 years.
  • •All participants had vaginal delivery with episiotomy.
  • •They are in late post partum period over 6 months
  • •Their BMI will be ranger from 25 to 30 kg/m
  • •All participants have mechanical low back pain.
  • •All participants have perineal pain.
  • •The Number of parity Ranged from 2-3 times.

Exclusion Criteria

  • •Females will be excluded if they have any spine or lower extremities injuries or previous surgeries.
  • •Females with radicular back pain.
  • •Inability to understand the written and verbal instruction.
  • •Females had irregular menstrual cycle

Arms & Interventions

Study group B

Experimental

They will receive the same traditional ultrasound therapy in addition to pelvic floor rehabilitation for six weeks

Intervention: Traditional ultrasound therapy (Device)

Study group B

Experimental

They will receive the same traditional ultrasound therapy in addition to pelvic floor rehabilitation for six weeks

Intervention: Pelvic floor rehabilitation (Other)

Control group A

Active Comparator

They will receive traditional ultrasound therapy for six weeks

Intervention: Traditional ultrasound therapy (Device)

Outcomes

Primary Outcomes

Assessment of osteomyoarticular symptoms

Time Frame: 6 weeks

It will be assessed before and after the end of treatment for each participant in both groups using Nordic Musculoskeletal Questionnaire (NMQ), an instrument characterized by multiple or binary choices facing osteomyoarticular symptoms in various anatomical regions that these symptoms appear more frequently, and a questionnaire that has good reliability (Legault et al., 2014).

Assessment of perineal pain intensity

Time Frame: 6 weeks

It will be assessed before and after the end of treatment for each participant in both groups through the visual analouge scale (VAS). It is a 10-cm horizontal line on which the patient's pain intensity was represented by a point between the extremes of "no pain at all" and "worst pain imaginable". Its simplicity, reliability and validity, as well as its ratio scale properties, make the VAS the optimal tool for describing pain intensity. Each participant will be asked to mark a point on the VAS line between the extremes that related to her perineal intensity. Then, the centimeters will be measured in each time from the left end of the line to the marked point to obtain the VAS score for perineal pain intensity

Secondary Outcomes

  • Assessment of pelvic floor muscle strength(6 weeks)
  • Assessment of lumbar spine mobility(6 weeks)
  • Assessment of pelvic floor muscle tightness(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aya T- Allah Mohamed Nabil Mohamed

PhD student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University

Cairo University

Study Sites (1)

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