- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05727566
Sexual Dysfunction in Patients With Myofascial Pain Syndrome
May 12, 2025 updated by: Ramazan Yılmaz, MD, Konya Beyhekim Training and Research Hospital
This study evaluates the frequency of sexual dysfunction in women with myofascial pain syndrome and its relationship with clinical parameters.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Konya, Turkey, 42060
- University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
40 patients with primer myofascial pain syndrome and 40 healthy volunteers
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with primer myofascial pain sydrome
pain for at least three months (myofascial pain) reproductive-aged married womens (18-50 years)
|
visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency
|
|
Healthy controls
Healthy control of reproductive-aged married women with compatible sociodemographic characteristics
|
visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexuality-importance score
Time Frame: 11.05.2022-15.03.2023 (cross-sectional)
|
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)
|
|
The frequency of sexual intercourse
Time Frame: 11.05.2022-15.03.2023 (cross-sectional
|
Weekly/monthly sexual intercourse frequency was asked of all participants.
|
11.05.2022-15.03.2023 (cross-sectional
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale (VAS pain/fatigue)
Time Frame: 11.05.2022 - 15.03.2023 (cross-sectional)
|
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)
|
|
Beck depression index (BDI)
Time Frame: 11.05.2022 - 15.03.2023 (cross-sectional)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ramazan Yılmaz, asist. prof, Konya Beyhekim Training and Research Hospital, Konya, Turkey
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2022
Primary Completion (Actual)
March 15, 2023
Study Completion (Actual)
April 15, 2023
Study Registration Dates
First Submitted
February 5, 2023
First Submitted That Met QC Criteria
February 5, 2023
First Posted (Actual)
February 14, 2023
Study Record Updates
Last Update Posted (Actual)
May 13, 2025
Last Update Submitted That Met QC Criteria
May 12, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KonyaBeyhekimTRH2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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