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Completed

NCT Number: NCT06262490

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

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 .

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Key information

Conditions

Chronic Perineal Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Disorders Pregnancy Complications Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/m2.
  • 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

Treatment and study plan

Traditional ultrasound therapy

Device

Ultrasound therapy for 2 session per week for until completing 12 treatment sessions (six weeks) with frequencies up to 3 MHz are used clinically to promote healing

Pelvic floor rehabilitation

Other

Pelvic floor rehabilitation for 3 sessions per week for (six weeks) until completing 18 sessions with sessions lasting between 30-45 minutes

Primary outcomes

  1. 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).

  2. 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

  1. Assessment of pelvic floor muscle strength

    Time frame: 6 weeks

    It will be assessed before and after the end of treatment for each participant in both groups by Kegel perineometer

  2. Assessment of pelvic floor muscle tightness

    Time frame: 6 weeks

    It will be assessed before and after the end of treatment for each participant in both groups by the manual pelvic floor muscle examination

  3. Assessment of lumbar spine mobility

    Time frame: 6 weeks

    It will be assessed before and after the end of treatment for each participant in both groups by the modified Schober test

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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