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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06262490
• Other study ID #: P.T.REC/012/004765
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Aya T- Allah M. Nabil, PhD student
• Phone: 01063028038
• Email: drayanabil1993[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Perineal Pain
• Pelvic Floor Disorders

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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