Clinical trial NCT05727566: Sexual Dysfunction in Patients With Myofascial Pain Syndrome
Official title: Sexual Dysfunction in Patients With Myofascial Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Myofascial Pain Syndrome
Keywords: sexual dysfunction
myofascial pain sydrome
pain
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-02-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 40 patients with primer myofascial pain syndrome and 40 healthy volunteers

Brief summary: This study evaluates the frequency of sexual dysfunction in women with myofascial pain syndrome and its relationship with clinical parameters.

Detailed description: The frequency of sexual dysfunction in reproductive-aged married women with primary myofascial pain syndrome will be evaluated in a prospective, cross-sectional survey-type study. The medical history of each participant was obtained and they underwent a detailed physical examination. Sociodemographic and clinic characteristics of all participants (age, education, marital status, employment status, family structure, income status, Body Mass Index(BMI), disease duration, number of pregnancies, sleep quality, etc.) were recorded. Pain and fatigue levels of the patients were measured by the visual pain scale (VAS), mood states by the Beck depression index (BDI), sexual function of the participants was assessed by the 0-10 Visual Analog Scale (VAS) to assess the degree of importance of sexuality (the sexuality-importance score). In addition, weekly/monthly sexual intercourse frequency was asked to all participants (patient and control groups). The questionnaires were administered to all participants in a room where they were alone with a female physician, and a suitable environment was provided for the patients to fill out the questionnaire. Patients were assured of the confidentiality of their information. Only questions that were not understood by the patient were explained without guidance.

Eligibility criteria: Inclusion Criteria:

* Myofascial pain syndrome (\>3 months) was diagnosed in a female.
* Being between the ages of 18 and 50, married, sexually active, and not menopausal
* Volunteering to participate in the study, and being able to communicate easily.

Exclusion Criteria:

* a history of systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, etc.)
* major psychiatric illness, mental retardation
* uncontrollable respiratory system problems
* endocrine diseases, neurological diseases
* previous hysterectomy or vaginal surgery, a history of sexually transmitted diseases
* urinary or anal incontinence
* limited motion in the upper or lower extremities
* Fibromyalgia
* inflammatory rheumatic diseases (such as rheumatoid arthritis, ankylosing spondylitis, etc.)
* cervical/lumbar radiculopathy or myelopathy
* communication problems
* pregnancy, lactation
* taking estrogen therapy
* use antidepressant, anxiolytic, and antiepileptic drugs
* chronic alcohol users

Primary outcomes:
measure: Sexuality-importance score
timeFrame: 11.05.2022-15.03.2023 (cross-sectional)
measure: The frequency of sexual intercourse
timeFrame: 11.05.2022-15.03.2023 (cross-sectional
Secondary outcomes:
measure: Visual analog scale (VAS pain/fatigue)
timeFrame: 11.05.2022 - 15.03.2023 (cross-sectional)
measure: Beck depression index (BDI)
timeFrame: 11.05.2022 - 15.03.2023 (cross-sectional)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Konya Beyhekim Training and Research Hospital, Konya, Turkey
name: Ramazan Yılmaz, asist. prof
role: STUDY_CHAIR
References:
citation: Yilmaz H, Yilmaz SD, Polat HA, Salli A, Erkin G, Ugurlu H. The effects of fibromyalgia syndrome on female sexuality: a controlled study. J Sex Med. 2012 Mar;9(3):779-85. doi: 10.1111/j.1743-6109.2011.02619.x. Epub 2012 Jan 12.