NCT05727566

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

February 5, 2023

Last Update Submit

May 12, 2025

Conditions

Sexual DysfunctionMyofascial Pain Syndrome

Keywords

sexual dysfunctionmyofascial pain sydromepain

Outcome Measures

Primary Outcomes (2)

  • 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)

  • The frequency of sexual intercourse

    Weekly/monthly sexual intercourse frequency was asked of all participants.

    11.05.2022-15.03.2023 (cross-sectional

Secondary Outcomes (2)

  • Visual analog scale (VAS pain/fatigue)

    11.05.2022 - 15.03.2023 (cross-sectional)

  • Beck depression index (BDI)

    11.05.2022 - 15.03.2023 (cross-sectional)

Study Arms (2)

Patients with primer myofascial pain sydrome

pain for at least three months (myofascial pain) reproductive-aged married womens (18-50 years)

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

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

Interventions

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

Healthy controlsPatients with primer myofascial pain sydrome

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

40 patients with primer myofascial pain syndrome and 40 healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation

Konya, 42060, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 22240036RESULT

  • Yilmaz 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.

    PMID: 37294458DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalMyofascial Pain SyndromesPain

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMuscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ramazan Yılmaz, asist. prof

    Konya Beyhekim Training and Research Hospital, Konya, Turkey

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asistant prof (MD)

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 14, 2023

Study Start

May 11, 2022

Primary Completion

March 15, 2023

Study Completion

April 15, 2023

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)