NCT07117019

Brief Summary

This study aims to determine the effect of the myofascial release combined with acupressure on BL23 on chronic perineal pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (2)

  • Assessment of the quality of the scar

    4 weeks

  • Assessment of quality of life

    4 weeks

Study Arms (2)

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.

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.

Other: Self-care and lifestyle intervention adviceOther: Myofascial releaseOther: Acupressure

Interventions

All females in both groups will follow self-care and lifestyle advice for 4 weeks.

Self-care and lifestyle intervention adviceSelf-care and lifestyle intervention advice + Myofascial release + Acupressure

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.

Self-care and lifestyle intervention advice + Myofascial release + Acupressure

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.

Self-care and lifestyle intervention advice + Myofascial release + Acupressure

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Self CareMyofascial Release TherapyAcupressure

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy Modalities

Study Officials

  • Hala Mohamed Hanafy, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Mai Mohamed Ali, PhD

    Assistant Professor, Cairo university

    STUDY DIRECTOR

Central Study Contacts

Diana Hosny Khalil Botros, B.Sc

CONTACT

Mai Mohamed Ali, PhD

CONTACT

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
Principal Investigator

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

August 12, 2025

Primary Completion

October 12, 2025

Study Completion

October 26, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Locations