Effect of Pelvic Floor Stretching on Pelvic Floor Myofascial Pain and Quality of Life in Postmenopausal Female

NCT07329218 | Completed

• 1 other identifier: AhmedAbdelhamid2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Menopause, also known as the climacteric, is the time when menstrual periods permanently stop, marking the end of reproduction, it typically occurs between the ages of 45 and 55, although the exact timing can vary, menopause is usually a natural change related to a decrease in circulating blood estrogen levels \[1\]. In the years before menopause, a woman's periods typically become irregular, which means that periods may be longer or shorter in duration or be lighter or heavier in the amount of flow. During this time, women often experience hot flashes; these typically last from 30 seconds to ten minutes and may be associated with shivering, night sweats, and reddening of the skin, while other symptoms may include vaginal dryness, trouble sleeping, and mood changes, the severity of symptoms varies between women \[2\]. Female pelvic floor muscles form a diaphragm that spans the entire pelvic cavity. They consist of the fibers of the coccygeus and the levator ani muscles, together with their fascia, the pelvic floor muscles provide support for the urethra, the vagina, and the rectum and constrict the urethral, vaginal, and anal orifices. Alterations in the composition of the pelvic floor muscles at menopause appear to affect their properties and, thereby, their ability to function adequately. This can lead to an increased prevalence in urinary incontinence and other lower urinary tract dysfunction, pelvic organ prolapses, and genitourinary syndrome of menopause \[3\]. During the menopausal transition, there is a substantial decrease in the number of ovarian follicles and numerous hormonal changes are observed. The first endocrine signal of the menopausal transition is a significant increase in follicle-stimulating hormone (FSH) levels. An important increase in FSH levels and a considerable decrease in estrogen and inhibin A concentrations are observed in the late stage of the menopausal transition. However, a 50% increase in FSH levels and a 50% decrease in estrogen concentrations are observed in the final postmenopausal period, these hormonal changes can directly affect pelvic floor muscle mass. After menopause, cross sectional areas of muscle mass decrease by 0.6% every year. Noncontractile muscle tissue mass (intramuscular fat mass) in postmenopausal women is two times greater that than in young women. The ratio of connective tissues to muscle fibrils in the urethral stricture and pelvic floor muscles decreases with age \[4\]. Non-surgical treatment of pelvic floor dysfunction mainly consists of manual approach, stimulation or relaxation techniques. Trigger points can be treated with local massage and stretching of the PFM. Using post isometric contraction techniques might help to give better stretching abilities of muscles \[8\]. In addition to manual manipulation, modalities such as electrostimulation, biofeedback, and vaginal dilators or vaginal weighted cones can be used to help with isolation of pelvic floor musculature and improve contraction. Electrical stimulation provides a small electrical current to contract the pelvic floor and assist the patient in isolation of the proper muscles. Biofeedback uses a vaginal or rectal pressure sensor to provide an audible and/or visual feedback of the strength of the muscle contraction. A vaginal weighted cone is inserted into the vagina and held in place by pelvic muscle contractions during activity Subjects and methods This study was a randomized controlled study. All procedures used in the study were compliant with the Declaration of Helsinki, which regulates research involving human subjects. Registration Clinical Trial Registration database (?) and approval from the Faculty of Physical Therapy, Delta University's institutional review board (F.P.T 250740). This study was carried out at an outpatient clinic at the Faculty of Physical Therapy, Delta University for Science and Technology, Egypt. The registration and recruitment of individuals and follow-up procedures were done from January 2025 to April 2025. Subjects: The patients were included in this study had these criteria: Females diagnosed with postmenopausal chronic pelvic pain between age group 45-55 years.

Conditions

Pelvic Floor Myofascial Pain

Keywords

postmenopausal female; pelvic floor myofascial pain; pelvic floor muscle stretching; pelvic floor muscle strengthening

Outcome Measures

Primary Outcomes (2)

• 1- Pain severity for pelvic floor myofascial pain

  Visual Analogue Scale (VAS) which is a reliable and effective tool of pain intensity that is sensitive to variations in pain caused by clinical conditions, was used to assess the severity of the pain. At the scale's left end, a zero means there is no pain, and a 10 means the most agonizing suffering possible. A minor improvement with a change of 1.1-1.2 cm is clinically meaningful

  pre the intervention and immediately after the intervention

• Quality of life assessment

  The Menopause Specific Quality of Life Questionnaire (MENQOL): It was developed by (Hilditch et al., 1996). using a sample of women 47-62 years old who had ceased menstruation for 2-7 years, who had not had a hysterectomy, and who had not used hormone therapy during the preceding 6 months. It is a validated questionnaire for the assessment of menopausal women's symptoms and an effective instrument. The questionnaire consists of 29 sub-items with a 7-point scale from 0 to 6, and includes four domains: vasomotor, psychosocial, physical, and sexual

  pre the intervention and immediately after the intervention

Study Arms (3)

Pelvic floor muscles Stretching

EXPERIMENTAL

The specification of the exercises are as follows Lie on the floor on the back. Slowly raise both the legs into the air. Hold the position for a few seconds. Slowly bring down the legs and then the knees as the patient return to the original resting position. Hold the position for 10 seconds and relax 30 seconds. Repeat 5 times. The exercises are performed for 10 minutes with warm up and cool down for duration of 10 minutes and for period of 4 weeks

Other: Pelvic floor muscles Stretching

Kegel Exercise

ACTIVE COMPARATOR

Patients will be in supine position with flexion of both lower limbs; they will be ordered to tighten perineum and anus for 10 seconds during inspiration, and then relaxed for 5\~10 seconds during exhalation for ten times per session and this exercise will be repeated three times in a day

Other: Kegel Exercise

Pelvic Rocking exercises

ACTIVE COMPARATOR

The woman will be positioned on her hands and knees, with her hands placed directly under her shoulders and her knees under her hips. Then she will be asked to breathe in deeply, tuck her head downward, and round her back up, making a curve with her back in the shape of the letter C. Hold this position for a count of 6, then breathe out slowly and bring her head back up. Relax, keeping the back straight-don't allow it to curve toward the floor. Hold this for a count of 6, this exercise was done 8 times for min.

Other: Pelvic Rocking exercises

Interventions

Kegel Exercise OTHER

already were described in arm descriptions

Also known as: Pelvic floor muscles Stretching

Kegel Exercise

Pelvic Rocking exercises OTHER

already were described in arm descriptions

Also known as: Pelvic floor muscles Stretching

Pelvic Rocking exercises

Pelvic floor muscles Stretching OTHER

already were described in arm descriptions

Pelvic floor muscles Stretching

Eligibility Criteria

• Age: 45 Years - 55 Years
• Gender Eligibility Details: our study on postmenopausal females so it is gender based
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females diagnosed with postmenopausal chronic pelvic pain between the ages of 45 and 55 years

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Horus University

Damietta, 11829., Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sixty female postmenopausal patients who had pelvic floor myofascial pain were chosen from the outpatient clinic of the Faculty of Physical Therapy, Delta University for Science and technology. education, occupation and duration of complaints of each patient. All were evaluated at the beginning of the treatment (week 0), at the endpoint of the treatment (week 4).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were randomized using the randomization block method into two groups, study (n=30) and control (n=30) groups. The allocation sequence was applied by a blinded and independent research assistant who opened sealed envelopes containing a computer-generated randomized number. study group received pelvic floor muscles stretching exercises while control group received Kegel exercises and pelvic rocking exercises.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: January 14, 2025
• Primary Completion: March 10, 2025
• Study Completion: April 14, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-01

Locations

EG (1)