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

NCT06262490 | Completed

• 1 other identifier: P.T.REC/012/004765
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chronic Perineal Pain; Pelvic Floor Disorders

Keywords

Pelvic floor rehabilitation; Ultrasound; Osteomyoarticular symptoms; Chronic Perineal pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Assessment of pelvic floor muscle strength

  6 weeks

• Assessment of pelvic floor muscle tightness

  6 weeks

• Assessment of lumbar spine mobility

  6 weeks

Study Arms (2)

Control group A

ACTIVE COMPARATOR

They will receive traditional ultrasound therapy for six weeks

Device: Traditional ultrasound therapy

Study group B

EXPERIMENTAL

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

Device: Traditional ultrasound therapy; Other: Pelvic floor rehabilitation

Interventions

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

Control group A; Study group B

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

Study group B

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Salwa M. El Badry, Prof.

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

  STUDY CHAIR

• Amel M. Yousef

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

EG (1)