Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-02 @ 10:11 AM
Study NCT ID:
NCT05727566
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2023-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Dysfunction in Patients With Myofascial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2023-02-05', 'studyFirstSubmitQcDate': '2023-02-05', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexuality-importance score', 'timeFrame': '11.05.2022-15.03.2023 (cross-sectional)', 'description': '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.'}, {'measure': 'The frequency of sexual intercourse', 'timeFrame': '11.05.2022-15.03.2023 (cross-sectional', 'description': 'Weekly/monthly sexual intercourse frequency was asked of all participants.'}], 'secondaryOutcomes': [{'measure': 'Visual analog scale (VAS pain/fatigue)', 'timeFrame': '11.05.2022 - 15.03.2023 (cross-sectional)', 'description': 'All participants were assessed in terms of pain and fatigue levels by means of a visual analogue scale of 0-10 cm (VAS).'}, {'measure': 'Beck depression index (BDI)', 'timeFrame': '11.05.2022 - 15.03.2023 (cross-sectional)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sexual dysfunction', 'myofascial pain sydrome', 'pain'], 'conditions': ['Sexual Dysfunction', 'Myofascial Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '22240036', 'type': 'RESULT', 'citation': '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': '37294458', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the frequency of sexual dysfunction in women with myofascial pain syndrome and its relationship with clinical parameters.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '40 patients with primer myofascial pain syndrome and 40 healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myofascial pain syndrome (\\>3 months) was diagnosed in a female.\n* Being between the ages of 18 and 50, married, sexually active, and not menopausal\n* Volunteering to participate in the study, and being able to communicate easily.\n\nExclusion Criteria:\n\n* a history of systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological, etc.)\n* major psychiatric illness, mental retardation\n* uncontrollable respiratory system problems\n* endocrine diseases, neurological diseases\n* previous hysterectomy or vaginal surgery, a history of sexually transmitted diseases\n* urinary or anal incontinence\n* limited motion in the upper or lower extremities\n* Fibromyalgia\n* inflammatory rheumatic diseases (such as rheumatoid arthritis, ankylosing spondylitis, etc.)\n* cervical/lumbar radiculopathy or myelopathy\n* communication problems\n* pregnancy, lactation\n* taking estrogen therapy\n* use antidepressant, anxiolytic, and antiepileptic drugs\n* chronic alcohol users'}, 'identificationModule': {'nctId': 'NCT05727566', 'briefTitle': 'Sexual Dysfunction in Patients With Myofascial Pain Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Konya Beyhekim Training and Research Hospital'}, 'officialTitle': 'Sexual Dysfunction in Patients With Myofascial Pain Syndrome', 'orgStudyIdInfo': {'id': 'KonyaBeyhekimTRH2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with primer myofascial pain sydrome', 'description': 'pain for at least three months (myofascial pain) reproductive-aged married womens (18-50 years)', 'interventionNames': ['Other: visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency']}, {'label': 'Healthy controls', 'description': 'Healthy control of reproductive-aged married women with compatible sociodemographic characteristics', 'interventionNames': ['Other: visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency']}], 'interventions': [{'name': 'visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency', 'type': 'OTHER', 'description': 'visual pain scale (VASpain/fatigue), Beck depression index (BDI), the sexuality-importance score, sexual intercourse frequency', 'armGroupLabels': ['Healthy controls', 'Patients with primer myofascial pain sydrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42060', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences, Konya Beyhekim Training and Research Hospital, Department of Physical Medicine and Rehabilitation', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Ramazan Yılmaz, asist. prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Konya Beyhekim Training and Research Hospital, Konya, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Beyhekim Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'asistant prof (MD)', 'investigatorFullName': 'Ramazan Yılmaz, MD', 'investigatorAffiliation': 'Konya Beyhekim Training and Research Hospital'}}}}