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

NCT ID: NCT06262490

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-08-01

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.

Conditions

Chronic Perineal Pain; Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group A

They will receive traditional ultrasound therapy for six weeks

Group Type: ACTIVE_COMPARATOR

Traditional ultrasound therapy

Intervention Type: 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

Study group B

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

Group Type: EXPERIMENTAL

Traditional ultrasound therapy

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya T- Allah Mohamed Nabil Mohamed

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salwa M. El Badry, Prof.

Role: STUDY_CHAIR

Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Amel M. Yousef

Role: STUDY_DIRECTOR

Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004765

Identifier Type: -

Identifier Source: org_study_id