Chronic Perineal PainNCT06262490
Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain
A study testing Traditional ultrasound therapy and Pelvic floor rehabilitation in people with Chronic Perineal Pain and Pelvic Floor Disorders, run by Cairo University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Chronic Perineal Pain, Pelvic Floor Disorders
- What is being tested?
- Traditional ultrasound therapy and Pelvic floor rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read the 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
- Being tested
- Traditional ultrasound therapy, Pelvic floor rehabilitation
- Keywords
- Pelvic floor rehabilitation, Ultrasound, Osteomyoarticular symptoms, Chronic Perineal pain
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ultrasound therapyDevice
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 rehabilitationOther
Pelvic floor rehabilitation for 3 sessions per week for (six weeks) until completing 18 sessions with sessions lasting between 30-45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control group A | Active comparator | They will receive traditional ultrasound therapy for six weeks Receives: 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 Receives: Device: Traditional ultrasound therapy; Other: Pelvic floor rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 6 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Perineal PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya T- Allah Mohamed Nabil Mohamed, Cairo University
- Investigators
- Salwa M. El Badry, Prof., Study chair, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.Amel M. Yousef, Study director, Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262490
- Sponsor's protocol ID
- P.T.REC/012/004765
- Status last verified
- Aug 2024
- First submitted
- 8 Feb 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain
- ClinicalTrials.gov ID
- NCT06262490
- Acronym / sponsor ID
- P.T.REC/012/004765
- Conditions
- Chronic Perineal Pain, Pelvic Floor Disorders
- Keywords
- Pelvic floor rehabilitation, Ultrasound, Osteomyoarticular symptoms, Chronic Perineal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group A | Active comparator | Device: Traditional ultrasound therapyThey will receive traditional ultrasound therapy for six weeks |
| Study group B | Experimental | Device: Traditional ultrasound therapy, Other: Pelvic floor rehabilitationThey will receive the same traditional ultrasound therapy in addition to pelvic floor rehabilitation for six weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional ultrasound therapyUltrasound 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 | Device | Control group A, Study group B |
| Pelvic floor rehabilitationPelvic floor rehabilitation for 3 sessions per week for (six weeks) until completing 18 sessions with sessions lasting between 30-45 minutes | Other | Study group B |
Primary outcome
Assessment of osteomyoarticular symptoms
Time frame: 6 weeks
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).
Assessment of perineal pain intensity
Time frame: 6 weeks
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
3 secondary outcomes
Assessment of pelvic floor muscle strength
Time frame: 6 weeks
Assessment of pelvic floor muscle tightness
Time frame: 6 weeks
Assessment of lumbar spine mobility
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salwa M. El Badry, Prof. study chair
Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
Amel M. Yousef study director
Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional ultrasound therapy and Pelvic floor rehabilitation in people with Chronic Perineal Pain and Pelvic Floor Disorders, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of osteomyoarticular symptoms (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.