Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05709951
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2023-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Blinding'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale for lower abdominal pain', 'timeFrame': '8 week', 'description': 'The subjective and verified visual analogue scale is used to quantify both acute and chronic pain (1). On the 10 cm line, scores are recorded by making a mark. Pain intensity is measured along a 10-cm line with 0 denoting "no pain" and 10 denoting "worst pain."'}, {'measure': 'Menstrual Symptom Questionnaire', 'timeFrame': '8 weeks', 'description': "Menstrual Symptom Questionnaire (MSQ) to assess dysmenorrhea symptoms. The MSQ is a 24 item self-report measure which assesses menstrual pain and symptoms (e.g. 'I have cramps that begin on the first day of my period'; 'I feel depressed for several days before my period'). The score on each item ranges from 1 (never) to 5 (always) with a higher composite score indicating more symptoms."}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '8 week', 'description': 'Pittsburgh Sleep Quality Index (PSQI) evaluates sleep disruptions and quality over a 1-month period. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Core stability,Exercises,Primary dysmenorrhea,sleep quality'], 'conditions': ['Primary Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'To compare the effects of Functional and Core stability exercises on pain and sleep quality in Patients with Primary Dysmenorrhea and to check the results of exercises may be effective in pain during Menstrual and before cramping in menses.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Female with primary dysmenorrhea', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having used medication for menstrual pain and not having used oral contraceptives during the three months prior to admission to the study.\n* Pain must be periodic (at least following 3 menstrual cycles).\n* Lower abdominal cramps pain ends after periods and gradually diminish over 12 to 72 hrs.\n* No history of blood disorders including thalassemia and folate or iron-deficiency anemia\n\nExclusion Criteria:\n\n* Pelvic inflammatory disease\n* Ovarian cysts\n* Chronic abdominal pain\n* Fibroids, obstructive endometrial polyps,\n* Irritable bowel syndrome\n* Major abdominal or pelvic surgery\n* Intrauterine devices.'}, 'identificationModule': {'nctId': 'NCT05709951', 'briefTitle': 'Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Functional Versus Core Stability Exercises on Pain and Sleep Quality in Patients With Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': 'RiphahIU fatimatariq1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Functional exercises', 'description': 'Piriformis stretching Cobra pose Sit up Bridging exercise', 'interventionNames': ['Other: Functional Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Core Stability Exercises', 'description': 'Pelvic bridging Plank Cat and camel Curl up', 'interventionNames': ['Other: Core Stability Exercises']}], 'interventions': [{'name': 'Functional Exercises', 'type': 'OTHER', 'otherNames': ['Exercises'], 'description': 'The patients were requested to perform these functional exercises for 4 days per week three times for 20 min (8 weeks).', 'armGroupLabels': ['Functional exercises']}, {'name': 'Core Stability Exercises', 'type': 'OTHER', 'otherNames': ['Exercises'], 'description': 'The patients were requested to perform 4 core strengthening exercises for 4 days per week three times for 20 min (8 weeks)', 'armGroupLabels': ['Core Stability Exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Hamid Sarwer, PG', 'role': 'CONTACT'}, {'name': 'Hamid Sarwer, Masters*', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jinnah Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Fatima Tariq, Phd', 'role': 'CONTACT', 'email': 'fatima.tariq@riphah.edu.pk', 'phone': '03344255033'}], 'overallOfficials': [{'name': 'Fatima Tariq, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}