Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-28 @ 5:14 PM
Study NCT ID:
NCT05979766
Status:
UNKNOWN
Last Update Posted:
2023-08-07
First Post:
2023-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Lymphatic Drainage vs Marian Clark Drainage in Pcs
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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manual lymphatic drainage', 'timeFrame': '6 months', 'description': 'Treatment protocol to group A\n\nIt consists of 15 patients who will receive manual lymphatic drainage 4 sessions per week for 12 weeks\n\nManual Lymph Drainage Techniques for Pelvic Decongestion\n\nStep 1: short neck treatment (supraclavicular fossa or SCF)\n\nStep 2: (two parts: visceral, deep)\n\nVisceral:\n\nDeep: Treatment of the thoracic duct, cisterna Chyli\n\nDeep Abdominal Manual lymphatic drainage\n\nStep-3. Treatment of right Axillary Lymph nodes\n\nStep-4. Establish the Right inguino-Axillary Anastomosis.\n\nStep-5. Decongest the right ipsilateral lower abdomen and suprapubic area\n\nStep-6 Treatment of Left Axillary Lymph nodes\n\nStep-7. Establish the Left inguino-Axillary Anastomosis.\n\nStep-8. Decongest the Let ipsilateral lower abdomen and suprapubic area'}, {'measure': 'Marian clark drainage', 'timeFrame': '6 months', 'description': 'It consists of 15 patients who will receive Marian clark drainage 4 sessions per week for 12 weeks each session will continue till therapist feels palpable change in congestion in pelvic area medial to Anterior superior Iliac spine.\n\n* Stand to the side of the patient\n* Patient semiprone on all fours\n* Hook fingers medial to both Anterior superior Iliac spine\n* Pull hands cephalad (traction)\n* Patient arches back like a cat\n* Encourage this movement with cephalad rocking\n* Repeat for several minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Congestive Syndrome']}, 'descriptionModule': {'briefSummary': "Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the pelvic region there is a constant hindrance in patient's daily professional and personal life due to the chronic pain. it can provide a definite way to improve pelvic congestion and quality of life. In this way it can benefit a large percentage of community females suffering from pelvic congestion syndrome and disability. This can grow at large length in favour of patients, clinicians and overall women health.", 'detailedDescription': "As per researcher's knowledge there are limited researches in which efficacy of manual lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative intervention i.e Marian Clark drainage is a rarely used osteopathic technique and not much studies have been conducted on it. This study helped to in identifying the effect of manual lymphatic drainage versus Marian Clark drainage on pain and disability in patients with pelvic congestion syndrome."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiparous women\n* Age ranging 20 to 50\n* Ovarian veins \\>4mm in diameter on Ultrasound Chronic pelvic pain/pressure for more than 6 months.\n* Dull, aching or "dragging" pain in the pelvis or lower back, particularly on standing and worse around the time of your menstrual period.\n* Pelvic pain that worsens as the day goes on, particularly if much time is spent standing dyspareunia\n* Swollen veins in pelvic region, butt, thighs, vulva and vagina.\n* Associated Irritable bladder/Irritable bowel present\n\nExclusion Criteria:\n\n* Pelvic pain due to other organic cause like uterine fibroids, Endometriosis, Ovarian cyst pelvic pain due to neurological or musculoskeletal disorder\n* Uterine prolapse\n* Pelvic cancer'}, 'identificationModule': {'nctId': 'NCT05979766', 'briefTitle': 'Manual Lymphatic Drainage vs Marian Clark Drainage in Pcs', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Manual Lymphatic Drainage Versus Marian Clark Drainage on Pain and Disability in Patients With Pelvic Congestion Syndrome', 'orgStudyIdInfo': {'id': 'RiphahIUmib'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual lymphatic drainage vs marian clark drainage', 'description': 'Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome', 'interventionNames': ['Other: Manual lymphatic drainage versus marian clark drainage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual lymphatic drainage versus marian clark drainage', 'description': 'Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome', 'interventionNames': ['Other: Manual lymphatic drainage versus marian clark drainage']}], 'interventions': [{'name': 'Manual lymphatic drainage versus marian clark drainage', 'type': 'OTHER', 'description': 'Manual lymphatic drainage versus marian clark drainage', 'armGroupLabels': ['Manual lymphatic drainage versus marian clark drainage', 'Manual lymphatic drainage vs marian clark drainage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Hafiza Neelam Muneeb, PT', 'role': 'CONTACT', 'email': 'hafiza.neelam@riphah.edu.pk', 'phone': '+92 320 4097476'}, {'name': 'Maira Imran Butt, MS-WHPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hafiza Neelam Muneeb', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jinnah hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad, Phd', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'Hafiza Neelam Muneeb, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}