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 .

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders; Chronic Perineal Pain
• Intervention / Treatment: Device: Traditional ultrasound therapy; Other: Pelvic floor rehabilitation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age of the subjects will be ranged from 20 to 35 years.
2. All participants had vaginal delivery with episiotomy.
3. They are in late post partum period over 6 months
4. Their BMI will be ranger from 25 to 30 kg/m2.
5. All participants have mechanical low back pain.
6. All participants have perineal pain.
7. The Number of parity Ranged from 2-3 times.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group A; They will receive traditional ultrasound therapy for six weeks	Device: Traditional ultrasound therapy; 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
Experimental: Study group B; They will receive the same traditional ultrasound therapy in addition to pelvic floor rehabilitation for six weeks	Device: Traditional ultrasound therapy; 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; Other: Pelvic floor rehabilitation; Pelvic floor rehabilitation for 3 sessions per week for (six weeks) until completing 18 sessions with sessions lasting between 30-45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of osteomyoarticular symptoms	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).	6 weeks
Assessment of perineal pain intensity	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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pelvic floor muscle strength	It will be assessed before and after the end of treatment for each participant in both groups by Kegel perineometer	6 weeks
Assessment of pelvic floor muscle tightness	It will be assessed before and after the end of treatment for each participant in both groups by the manual pelvic floor muscle examination	6 weeks
Assessment of lumbar spine mobility	It will be assessed before and after the end of treatment for each participant in both groups by the modified Schober test	6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Salwa M. El Badry, Prof., Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.; Study Director: Amel M. Yousef, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Pelvic floor rehabilitation; Osteomyoarticular symptoms; Chronic Perineal pain
• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pelvic Floor Disorders
• Other Study ID Numbers: P.T.REC/012/004765

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No