Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT06051435
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-17', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of lumbar proprioception', 'timeFrame': '4 weeks', 'description': 'It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy.'}], 'secondaryOutcomes': [{'measure': 'Calculation of score of WaLIDD Scale', 'timeFrame': '4 weeks', 'description': 'It will be used to identify dysmenorrhea severity in both groups before and after treatment program through measuring combination of manifestations: subjective (intensity/Wong-Baker, work ability) and objective (days of pain, location) for both groups.The total score of 0 indicates without dysmenorrhea; 1-4 indicates mild dysmenorrhea, 5-7 indicates moderate dysmenorrhea, 8-12 indicates severe dysmenorrhea (Teherán et al., 2018).'}, {'measure': 'lumbar curvature angle', 'timeFrame': '4 weeks', 'description': 'it will be measured by Flexible ruler which is affected by the tilt of the pelvis, in both groups before and after treatment program.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar proprioception training', 'pelvic rocking exercises', 'primary dysmenorrhea'], 'conditions': ['Primary Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'the aim of this study will be to investigate the effect of lumbar proprioception training on primary dysmenorrhea.', 'detailedDescription': 'Although previous studies reported the effect of physiotherapy practices through therapeutic exercises on primary dysmenorrhea as core muscles strengthening, core stability exercises, connective tissue massage and classical massage, relaxation, strengthening, stretching, aerobic exercises, pelvic floor muscle strengthening exercises, yoga and Pilates. None of them have investigated the effect of lumbar proprioception training on primary dysmenorrhea. Therefore, this study will be the first one which aims to investigate the effect of lumbar proprioception training on primary dysmenorrhea. This trial will include 2 groups; group A composed of 20 females that will receive hot packs and pelvic rocking exercises for 4 weeks and group B also composed of 20 females that will receive hot packs and pelvic rocking exercises in addition to lumbar proprioception training for 4 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All females will have moderate to severe primary dysmenorrhea (as determined by WaLIDD Scale).\n* Their ages will range from 18 to 22 years old.\n* All females will be virginal and non-smokers.\n* Their BMI will be range from 20-25 kg/m2\n* They have regular menstrual cycle with menstrual cycle length of 28-30 days.\n* They have persistent primary dysmenorrhea of more than 6 months\n\nExclusion Criteria:\n\n* They shouldn't have musculoskeletal or neurological disorders, chronic LBP or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease.\n* They shouldn't experience a stressful event in the last 6 month.\n* Attending regular exercise training in the last 6 months.\n* Taking medications or vitamin and mineral supplements due to other medical conditions."}, 'identificationModule': {'nctId': 'NCT06051435', 'briefTitle': 'Effect of Lumbar Proprioception Training on Primary Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Lumbar Proprioception Training on Primary Dysmenorrhea: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'They will receive hot packs and pelvic rocking exercises for one menstrual cycle.', 'interventionNames': ['Other: Hot packs', 'Other: Pelvic rocking exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Lumbar proprioception group', 'description': 'They will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle.', 'interventionNames': ['Other: lumbar proprioception training', 'Other: Hot packs', 'Other: Pelvic rocking exercise']}], 'interventions': [{'name': 'lumbar proprioception training', 'type': 'OTHER', 'otherNames': ['lumbar proprioception exercises'], 'description': "a) Sensorimotor training: Sensorimotor training and reconditioning of proprioceptive senses have recently been found to be helpful in increasing motor performance and coordination, muscle strength, sensorimotor abilities, increasing intermuscular control, and improving one's response to sensory information and muscle tone. Reconditioning of proprioceptive senses and sensorimotor training increases one's muscle adjustment ability, maximizes the sensory input in different parts of the body and aids in improving one's motor adjustment ability (Hwang et al ., 2013).\n\nPosition Exercise methods as Hollowing exercise: Participants will be asked to contract the abdominal muscles, raising the center of movement toward the navel in a quadruped position.", 'armGroupLabels': ['Lumbar proprioception group']}, {'name': 'Hot packs', 'type': 'OTHER', 'description': 'hot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation', 'armGroupLabels': ['Control group', 'Lumbar proprioception group']}, {'name': 'Pelvic rocking exercise', 'type': 'OTHER', 'description': 'Pelvic rocking exercise', 'armGroupLabels': ['Control group', 'Lumbar proprioception group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Doaa Osman', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Amel Mohamed Yousef, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor, Cairo university'}, {'name': 'Hamada Ahmed Hamada, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor, Cairo university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Assistant professor Physical Therapy for Woman's Health Faculty of Physical Therapy Cairo University", 'investigatorFullName': 'Doaa A. Osman', 'investigatorAffiliation': 'Cairo University'}}}}