Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-03-07 @ 11:59 PM
Study NCT ID:
NCT06762106
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-04', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'every month for three menstrual cycle', 'description': 'VAS scoring method. 0 is the least while 10 is the highest'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dysmenorrhea', 'lower back pain', 'shock wave'], 'conditions': ['Dysmenorrhea', 'Back Pain Lower Back']}, 'descriptionModule': {'briefSummary': 'Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour', 'detailedDescription': 'Dysmenorrhea is one of the most common gynecological conditions in women. Primary dysmenorrhea (PD), defined as menstrual pain without any structural lesions, usually begins shortly before or immediately after the onset of the menstrual cycle and commonly lasts for 48 to 72 hour. It is accompanied by general symptoms, such as nausea and vomiting, malaise, weakness, lower backache, and diarrhea. In ovulatory cycles, women secrete high levels of or have increased sensitivity to prostaglandins. These prostaglandins may stimulate myometrial contractions and sensitize pain fibers, and thus induce pelvic pain.\n\nFemales of reproductive age often suffer from dysmenorrhea, a painful condition. Despite dysmenorrhea being generally considered a benign condition, a significant disability can result from it. Researchers suggest that dysmenorrhea has been linked to migraines, headaches, and fibromyalgia, among other painful disorders. The authors reported further evidence that dysmenorrhea can alter noxious sensory processing.\n\nPrimary dysmenorrhea usually begins six to 12 months after menarche and is characterized by spasmodic cramping pain in the lower abdomen that can radiate to the lower back and anterior or inner thighs. The pain usually has a clear temporal pattern: it begins a few hours before or at the start of menstruation, is most intense at onset, gradually waning over two to three days.\n\nThe purpose of this study was to investigate the effectiveness shockwave therapy on low back pain in primary dysmenorrhea.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'as menstruation is found only in females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Their ages ranged from 18 to 30 years.\n* Their BMI were not exceeding 29 Kg/m2.\n* All patients were clinically diagnosed as low back pain during Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guideline\n\nExclusion Criteria:\n\n* Any known chronic disease (such as cardiovascular or renal diseases) or secondary dysmenorrhea.\n* Being pregnant or planning to get pregnant any time during the trial.\n* Having received other treatments for PD in the past half year.\n* Irregular menstrual cycles.\n* Mental or neurological disorder'}, 'identificationModule': {'nctId': 'NCT06762106', 'briefTitle': 'Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Deraya University'}, 'officialTitle': 'Effect of Shockwave Therapy on Low Back Pain in Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': 'physio 12 24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hot back group', 'description': '30 subjects were treated by hot back in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles', 'interventionNames': ['Radiation: hot back']}, {'type': 'EXPERIMENTAL', 'label': 'shock wave and hot back group', 'description': '30 subjects were treated by hot back and shockwave therapy in the first 3 days of the menstrual cycle (follicular phase) for three consecutive menstrual cycles', 'interventionNames': ['Radiation: shockwave therapy']}], 'interventions': [{'name': 'shockwave therapy', 'type': 'RADIATION', 'description': 'solid unite made with metal frame and case', 'armGroupLabels': ['shock wave and hot back group']}, {'name': 'hot back', 'type': 'RADIATION', 'description': 'thermal hot back', 'armGroupLabels': ['Hot back group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05637', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deraya University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}