Sexual Dysfunction in Patients With Myofascial Pain Syndrome

Sexual Dysfunction Clinical Trial

Official title:

Sexual Dysfunction in Patients With Myofascial Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727566
• Other study ID #: KonyaBeyhekimTRH2022
• Status: Recruiting
• Start date: May 11, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: February 2023
• Source: Konya Beyhekim Training and Research Hospital
• Contact: Ramazan Yilmaz, asist. prof
• Phone: +90 555 6232674
• Email: drramazanyilmaz[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 15, 2023
• Est. primary completion date: February 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Sexual Dysfunction
• Somatoform Disorders
• Syndrome

Intervention

Other:
• visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency
visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Beyhekim Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexuality-importance score	Sexual function of the participants was assessed by the 0 (never mind)-10(very important) Visual Analog Scale (VAS) to assess the degree of importance of sexuality.	11.05.2022-15.03.2023 (cross-sectional)
Primary	The frequency of sexual intercourse	Weekly/monthly sexual intercourse frequency was asked of all participants.	11.05.2022-15.03.2023 (cross-sectional
Secondary	Visual analog scale (VAS pain/fatigue)	All participants were assessed in terms of pain and fatigue levels by means of a visual analogue scale of 0-10 cm (VAS).	11.05.2022 - 15.03.2023 (cross-sectional)
Secondary	Beck depression index (BDI)	In the assessment of depression severity, the Turkish version of the 21-item Beck Depression Inventory (BDI) was used, which is one of the most common psychometric tests used and a value of 0 to 3 is assigned for each answer to each item.	11.05.2022 - 15.03.2023 (cross-sectional)