Chronic Perineal PainNCT07117019
Effect of Myofascial Release Combined With Acupressure on BL23 On Chronic Perineal Pain
A study testing Self-care and lifestyle intervention advice, Myofascial release and Acupressure in people with Chronic Perineal Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to determine the effect of the myofascial release combined with acupressure on BL23 on chronic perineal pain. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Perineal Pain
- What is being tested?
- Self-care and lifestyle intervention advice, Myofascial release and Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2025to 26 Oct 2025
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women will be diagnosed with chronic perineal pain from episiotomy scar and referred by the gynecologist.
- Their age will range from 18 to 30 years.
- They should not have skin irritation/inflammation at the perineum.
- They should not receive epidural anesthesia, ice packs, or non-steroidal anti-inflammatory drugs during the treatment sessions.
- They should not suffer from major physical problems such as spinal fractures or disc Hernias.
Who cannot join
- Having a laceration other than an episiotomy.
- Having an operative vaginal delivery (forceps, vacuum).
- Chronic disease (diabetes mellitus, thyroid, hypertension).
- Regular medication use or any postnatal complication in the newborn.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to determine the effect of the myofascial release combined with acupressure on BL23 on chronic perineal pain.
Read the detailed description
Perineal pain is a typical sequel vaginal delivery, affecting up to 42% of women at ten days postpartum and persisting in 10% at 18 months. As the fibers of scar tissue form, however, they are typically weaker, with more limited movement and less oxygen circulation than normal skin tissue. This lack of skin and muscle elasticity around an episiotomy or perineal scar can result in side effects, such as pain during sex or when passing a stool, urinary or fecal incontinence, pelvic organ prolapse, and ongoing infections. Moreover, chronic perineal pain can affect the woman psychologically and impact the transition to parenthood, the sexual relationship with her partner, and their ability to breastfeed.
Pharmacological therapies are effective; however, they have side effects as they can pass into breast milk and subsequent harm to the neonate. So, studies need to test and support the effectiveness and safety of some non-pharmacological techniques that could benefit a wide range of women suffering from postpartum perineal pain.
Perineal massage enhances perineal results by stretching the tissues of the vagina, facilitating perineal relaxation, and increasing tissue circulation. Acupressure is a noninvasive method whose nature is similar to acupuncture. This method is effective in sedating pain and reducing its intensity. Some researchers believe that acupressure prevents the transfer of pain stimulators, increases blood endorphin levels, and reduces pain.
Therefore, this study will be carried out to verify the effect of myofascial release and acupressure on postpartum perineal pain.
To our knowledge, this study is the first to investigate the effect of myofascial release combined with acupressure on chronic postpartum perineal pain. Therefore, this study will be conducted to provide physiotherapists with updated scientific knowledge concerning the effect of adding the myofascial release to acupressure on chronic perineal pain, aiming to improve quality of life and decrease pain. This study may expand the role of physiotherapy in women's health.
- Conditions
- Chronic Perineal Pain
- Being tested
- Self-care and lifestyle intervention advice, Myofascial release, Acupressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-care and lifestyle intervention adviceOther
All females in both groups will follow self-care and lifestyle advice for 4 weeks.
Myofascial releaseOther
Females in the experimental group will receive intravaginal myofascial release in lithotomic position. After ensuring empty bladder/bowel, therapist uses sterile gloves and lubricant to insert fingers 2-3cm into vagina, pressing vaginal walls bilaterally for 2 minutes. Perineal massage follows, targeting scar tissue and tender points with friction at right angles. Treatment duration starts at 5 minutes (due to pain tolerance) and gradually increases to 20 minutes. Hot pack or ultrasound may be used pre-treatment for pain relief. Therapist performs gentle U-shaped reciprocating massage movements up and down towards rectum for 20 minutes total. Sterile technique maintained throughout with hand washing and glove changes between procedures.
AcupressureOther
Each female in the experimental group will receive acupressure on BL 23 as follows: Acupressure is also another branch of acupuncture. In this method, fingers press the key points on the skin to stimulate and induce the body's natural self-healing capabilities. In the present study, the BL23 point located 1.5 cm lateral to the lower border of the spinous process of the second lumbar vertebra was employed.
The therapist will apply pressure on BL 23 points with the thumb for 5 minutes in the counterclockwise direction. In the second 5 minutes, pressure was applied in the opposite direction for 5 minutes. Similarly, the pressure was continued for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Self-care and lifestyle intervention advice | Active comparator | It will include 20 women suffering from chronic postpartum perineal pain. They will receive self-care and lifestyle intervention advice for four weeks during their daily lifestyle routine. Receives: Other: Self-care and lifestyle intervention advice |
| Self-care and lifestyle intervention advice + Myofascial release + Acupressure | Experimental | It will include 20 women suffering from chronic postpartum perineal pain. They will receive the same advice as in the experimental group in addition to myofascial release and acupressure on the BL23 point, three sessions per week for four weeks. The duration of the session will be 40 minutes. Receives: Other: Self-care and lifestyle intervention advice; Other: Myofascial release; Other: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of intensity of perineal pain
The McGill Pain Questionnaire assesses subjective pain experience through three major word descriptor classes: sensory, affective, and evaluative, plus an intensity scale. It provides three quantitative measures: (1) Pain Rating Index (PRI) - based on rank values where words implying least pain=1, increasing sequentially. Separate scores calculated for sensory (subclasses 1-10), affective (11-15), evaluative (16), and miscellaneous (17-20) categories, plus total score (1-20). (2) Number of Words Chosen (NWC) - total descriptors selected. (3) Present Pain Intensity (PPI) - number-word combination indicating overall pain intensity at administration time using 1-5 scale. Designed for statistical analysis of clinical pain.
Measured: 4 weeks
Secondary outcomes (2)
Assessment of the quality of the scar
The Patient and Observer Scar Assessment Scale (POSAS) is a dual-component tool for evaluating scars. The Observer Scale rates 5 variables (vascularity, pigmentation, thickness, relief, pliability, surface area) using 10-point scoring, totaling 5-50 points. The Patient Scale assesses 6 items (pain, itching, color, stiffness, thickness, irregularity) also using 10-point scoring, totaling 6-60 points. Lower scores indicate normal skin. POSAS demonstrates superior internal consistency and inter-observer reliability compared to the Vancouver Scar Scale, with the unique advantage of incorporating patient subjective assessments alongside objective clinical observations, making it ideal for comprehensive post-surgical scar evaluation.
Measured: 4 weeks
Assessment of quality of life
The EuroQol five-dimensional (EQ-5D) is a generic preference-based instrument measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three response levels (1=no problem, 2=moderate problem, 3=severe problem). These can be converted into a summary index score with maximum value of 1 (best health state). Additionally, it includes a visual analogue scale (VAS) rating general health status from 0-100, where 100 represents optimal health. The EQ-5D is widely used for creating health profiles and calculating utility values for economic evaluations.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start12 Aug 2025
- Primary completion12 Oct 2025
- Study completion26 Oct 2025
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, Diana Hosny khalil Botros, Cairo University
- Investigators
- Hala Mohamed Hanafy, PhD, Study chair, Professor, Cairo universityMai Mohamed Ali, PhD, Study director, Assistant Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117019
- Sponsor's protocol ID
- P.T.REC/012/005183
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2025
- Last updated
- 6 Apr 2026
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Myofascial Release Combined With Acupressure on BL23 On Chronic Perineal Pain
- ClinicalTrials.gov ID
- NCT07117019
- Acronym / sponsor ID
- P.T.REC/012/005183
- Conditions
- Chronic Perineal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 12 Oct 2025 (actual)
- Study completion
- 26 Oct 2025 (actual)
- First posted
- 12 Aug 2025 (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.
This study aims to determine the effect of the myofascial release combined with acupressure on BL23 on chronic perineal pain.
Detailed description
Perineal pain is a typical sequel vaginal delivery, affecting up to 42% of women at ten days postpartum and persisting in 10% at 18 months. As the fibers of scar tissue form, however, they are typically weaker, with more limited movement and less oxygen circulation than normal skin tissue. This lack of skin and muscle elasticity around an episiotomy or perineal scar can result in side effects, such as pain during sex or when passing a stool, urinary or fecal incontinence, pelvic organ prolapse, and ongoing infections. Moreover, chronic perineal pain can affect the woman psychologically and impact the transition to parenthood, the sexual relationship with her partner, and their ability to breastfeed.
Pharmacological therapies are effective; however, they have side effects as they can pass into breast milk and subsequent harm to the neonate. So, studies need to test and support the effectiveness and safety of some non-pharmacological techniques that could benefit a wide range of women suffering from postpartum perineal pain.
Perineal massage enhances perineal results by stretching the tissues of the vagina, facilitating perineal relaxation, and increasing tissue circulation. Acupressure is a noninvasive method whose nature is similar to acupuncture. This method is effective in sedating pain and reducing its intensity. Some researchers believe that acupressure prevents the transfer of pain stimulators, increases blood endorphin levels, and reduces pain.
Therefore, this study will be carried out to verify the effect of myofascial release and acupressure on postpartum perineal pain.
To our knowledge, this study is the first to investigate the effect of myofascial release combined with acupressure on chronic postpartum perineal pain. Therefore, this study will be conducted to provide physiotherapists with updated scientific knowledge concerning the effect of adding the myofascial release to acupressure on chronic perineal pain, aiming to improve quality of life and decrease pain. This study may expand the role of physiotherapy in women's health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-care and lifestyle intervention advice | Active comparator | Other: Self-care and lifestyle intervention adviceIt will include 20 women suffering from chronic postpartum perineal pain. They will receive self-care and lifestyle intervention advice for four weeks during their daily lifestyle routine. |
| Self-care and lifestyle intervention advice + Myofascial release + Acupressure | Experimental | Other: Self-care and lifestyle intervention advice, Other: Myofascial release, Other: AcupressureIt will include 20 women suffering from chronic postpartum perineal pain. They will receive the same advice as in the experimental group in addition to myofascial release and acupressure on the BL23 point, three sessions per week for four weeks. The duration of the session will be 40 minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All women will be diagnosed with chronic perineal pain from episiotomy scar and referred by the gynecologist.
- Their age will range from 18 to 30 years.
- They should not have skin irritation/inflammation at the perineum.
- They should not receive epidural anesthesia, ice packs, or non-steroidal anti-inflammatory drugs during the treatment sessions.
- They should not suffer from major physical problems such as spinal fractures or disc Hernias.
Key exclusion criteria (4 listed)
- Having a laceration other than an episiotomy.
- Having an operative vaginal delivery (forceps, vacuum).
- Chronic disease (diabetes mellitus, thyroid, hypertension).
- Regular medication use or any postnatal complication in the newborn.
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 |
|---|---|---|
| Self-care and lifestyle intervention adviceAll females in both groups will follow self-care and lifestyle advice for 4 weeks. | Other | Self-care and lifestyle intervention advice, Self-care and lifestyle intervention advice + Myofascial release + Acupressure |
| Myofascial releaseFemales in the experimental group will receive intravaginal myofascial release in lithotomic position. After ensuring empty bladder/bowel, therapist uses sterile gloves and lubricant to insert fingers 2-3cm into vagina, pressing vaginal walls bilaterally for 2 minutes. Perineal massage follows, targeting scar tissue and tender points with friction at right angles. Treatment duration starts at 5 minutes (due to pain tolerance) and gradually increases to 20 minutes. Hot pack or ultrasound may be used pre-treatment for pain relief. Therapist performs gentle U-shaped reciprocating massage movements up and down towards rectum for 20 minutes total. Sterile technique maintained throughout with hand washing and glove changes between procedures. | Other | Self-care and lifestyle intervention advice + Myofascial release + Acupressure |
| AcupressureEach female in the experimental group will receive acupressure on BL 23 as follows: Acupressure is also another branch of acupuncture. In this method, fingers press the key points on the skin to stimulate and induce the body's natural self-healing capabilities. In the present study, the BL23 point located 1.5 cm lateral to the lower border of the spinous process of the second lumbar vertebra was employed. The therapist will apply pressure on BL 23 points with the thumb for 5 minutes in the counterclockwise direction. In the second 5 minutes, pressure was applied in the opposite direction for 5 minutes. Similarly, the pressure was continued for 20 minutes. | Other | Self-care and lifestyle intervention advice + Myofascial release + Acupressure |
Primary outcome
Assessment of intensity of perineal pain
Time frame: 4 weeks
The McGill Pain Questionnaire assesses subjective pain experience through three major word descriptor classes: sensory, affective, and evaluative, plus an intensity scale. It provides three quantitative measures: (1) Pain Rating Index (PRI) - based on rank values where words implying least pain=1, increasing sequentially. Separate scores calculated for sensory (subclasses 1-10), affective (11-15), evaluative (16), and miscellaneous (17-20) categories, plus total score (1-20). (2) Number of Words Chosen (NWC) - total descriptors selected. (3) Present Pain Intensity (PPI) - number-word combination indicating overall pain intensity at administration time using 1-5 scale. Designed for statistical analysis of clinical pain.
2 secondary outcomes
Assessment of the quality of the scar
Time frame: 4 weeks
Assessment of quality of life
Time frame: 4 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 6 Apr 2026.
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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.
Hala Mohamed Hanafy, PhD study chair
Professor, Cairo university
Mai Mohamed Ali, PhD study director
Assistant Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-care and lifestyle intervention advice, Myofascial release and Acupressure in people with Chronic Perineal Pain, 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 5 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 6 Apr 2026. 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 intensity of perineal pain (time frame: 4 weeks). 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 6 Apr 2026.