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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06262490
Enrollment
40
Registered
2024-02-16
Start date
2024-03-01
Completion date
2024-08-01
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Perineal Pain, Pelvic Floor Disorders

Keywords

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

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.

Interventions

DEVICETraditional 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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of osteomyoarticular symptoms6 weeksIt 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).
Assessment of perineal pain intensity6 weeksIt 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

MeasureTime frameDescription
Assessment of pelvic floor muscle strength6 weeksIt will be assessed before and after the end of treatment for each participant in both groups by Kegel perineometer
Assessment of pelvic floor muscle tightness6 weeksIt will be assessed before and after the end of treatment for each participant in both groups by the manual pelvic floor muscle examination
Assessment of lumbar spine mobility6 weeksIt will be assessed before and after the end of treatment for each participant in both groups by the modified Schober test

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026