Sexual Dysfunction in Patients With Myofascial Pain Syndrome

Sponsor
Konya Beyhekim Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05727566
Collaborator
(none)
80
1
10.1
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Study Details

Study Description

Brief Summary

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

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

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

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Sexual Dysfunction in Patients With Myofascial Pain Syndrome
Actual Study Start Date :
May 11, 2022
Actual Primary Completion Date :
Feb 5, 2023
Anticipated Study Completion Date :
Mar 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sexuality-importance score [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.

  2. The frequency of sexual intercourse [11.05.2022-15.03.2023 (cross-sectional]

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

Secondary Outcome Measures

  1. Visual analog scale (VAS pain/fatigue) [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).

  2. Beck depression index (BDI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation Konya Turkey 42060

Sponsors and Collaborators

  • Konya Beyhekim Training and Research Hospital

Investigators

  • Study Chair: Ramazan Yılmaz, asist. prof, Konya Beyhekim Training and Research Hospital, Konya, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramazan Yılmaz, asistant prof (MD), Konya Beyhekim Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05727566
Other Study ID Numbers:
  • KonyaBeyhekimTRH2022
First Posted:
Feb 14, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ramazan Yılmaz, asistant prof (MD), Konya Beyhekim Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2023