Sexual DysfunctionNCT05727566
Sexual Dysfunction in Patients With Myofascial Pain Syndrome
An observational study of Sexual Dysfunction and Myofascial Pain Syndrome, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the frequency of sexual dysfunction in women with myofascial pain syndrome and its relationship with clinical parameters. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction, Myofascial Pain Syndrome
- What is being tested?
- visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2022to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 40 patients with primer myofascial pain syndrome and 40 healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Konya, 42060
About this study
This study evaluates the frequency of sexual dysfunction in women with myofascial pain syndrome and its relationship with clinical parameters.
Read the 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.
- Conditions
- Sexual Dysfunction, Myofascial Pain Syndrome
- Being tested
- visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency
- Keywords
- sexual dysfunction, myofascial pain sydrome, pain
- Medical subject headings
- Sexual Dysfunction, Physiological, Myofascial Pain Syndromes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequencyOther
visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency
| Study group | Role | What they receive |
|---|---|---|
| Patients with primer myofascial pain sydrome | pain for at least three months (myofascial pain) reproductive-aged married womens (18-50 years) Receives: Other: 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 Receives: Other: visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 11.05.2022-15.03.2023 (cross-sectional)
The frequency of sexual intercourse
Weekly/monthly sexual intercourse frequency was asked of all participants.
Measured: 11.05.2022-15.03.2023 (cross-sectional
Secondary outcomes (2)
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).
Measured: 11.05.2022 - 15.03.2023 (cross-sectional)
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.
Measured: 11.05.2022 - 15.03.2023 (cross-sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start11 May 2022
- Primary completion15 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ramazan Yılmaz, MD, Konya Beyhekim Training and Research Hospital
- Investigators
- Ramazan Yılmaz, asist. prof, Study chair, Konya Beyhekim Training and Research Hospital, Konya, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727566
- Sponsor's protocol ID
- KonyaBeyhekimTRH2022
- Status last verified
- May 2025
- First submitted
- 5 Feb 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22240036Yilmaz R, Karpuz S, Akdere E, Yilmaz H. Evaluation of sexual dysfunction in females with neck and upper back myofascial pain syndrome: a cross-sectional study. Rheumatol Int. 2023 Sep;43(9):1723-1732. doi: 10.1007/s00296-023-05359-6. Epub 2023 Jun 9.
PubMed 37294458
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Patients With Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT05727566
- Acronym / sponsor ID
- KonyaBeyhekimTRH2022
- Conditions
- Sexual Dysfunction, Myofascial Pain Syndrome
- Keywords
- sexual dysfunction, myofascial pain sydrome, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 11 May 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with primer myofascial pain sydrome | – | Other: visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequencypain for at least three months (myofascial pain) reproductive-aged married womens (18-50 years) |
| Healthy controls | – | Other: visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequencyHealthy control of reproductive-aged married women with compatible sociodemographic characteristics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 patients with primer myofascial pain syndrome and 40 healthy volunteers
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequencyvisual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency | Other | Healthy controls, Patients with primer myofascial pain sydrome |
Primary outcome
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.
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.
2 secondary outcomes
Visual analog scale (VAS pain/fatigue)
Time frame: 11.05.2022 - 15.03.2023 (cross-sectional)
Beck depression index (BDI)
Time frame: 11.05.2022 - 15.03.2023 (cross-sectional)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Results publication: PubMed 22240036Yilmaz 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.
- Derived from this study: PubMed 37294458Yilmaz R, Karpuz S, Akdere E, Yilmaz H. Evaluation of sexual dysfunction in females with neck and upper back myofascial pain syndrome: a cross-sectional study. Rheumatol Int. 2023 Sep;43(9):1723-1732. doi: 10.1007/s00296-023-05359-6. Epub 2023 Jun 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan Yılmaz, asist. prof study chair
Konya Beyhekim Training and Research Hospital, Konya, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction and Myofascial Pain Syndrome, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexuality-importance score (time frame: 11.05.2022-15.03.2023 (cross-sectional)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05727566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.