Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT04178304
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2019-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prolotherapy in Knee Osteoarthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075527', 'term': 'Prolotherapy'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'the Assessor doing the musculoskeletal ultrasound will be masked to the radiographic grading of knee osteoarthritis, the clinical condition and the improvement following prolotgerapy.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Sixty knees with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: 1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done. 2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose. Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals. Follow up will be done at 24 weeks after the last injection both clinically and ultrasounographicly.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-31', 'studyFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2019-11-24', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain, Stiffness and Physical function', 'timeFrame': '24 weeks after last injection', 'description': 'whether prolotherapy improves physical function by Western Ontario and McMaster University (WOMAC) index and VAS in patients with primary knee osteoarthritis'}], 'secondaryOutcomes': [{'measure': 'Cartilage thickness', 'timeFrame': '24 weeks after last injection', 'description': 'whether an increase in cartilage thickness could be detected by the musculoskeletal ultrasound following prolotherapy'}, {'measure': 'Safety and Tolerability', 'timeFrame': '24 weeks after last injection', 'description': 'safety and tolerability will be assessed using patient satisfaction Likeret 5 point scale'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary knee osteoarthritis,', 'prolotherapy,', 'musculoskeletal ultrasound'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Patients with primary knee osteoarthritis will be included in the study, plain X-ray for the affected knee, followed by musculoskeletal ultrasound assessment will be done. The intervention: intra-articular injection and extra-articular injections of 25% dextrose. Follow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .\n\nAim: Determine whether prolotherapy improves pain. stiffness and function of symptomatic knee osteoarthritis and determine ultrasonographic changes before and after prolotherapy.', 'detailedDescription': 'Sixty knees with primary knee osteoarthritis will be included in the study, clinical assessment will be done, then plain X-ray for the affected knee (s), followed by musculoskeletal ultrasound assessment will be done.\n\nThe intervention:\n\n1. a single intra-articular injection of 6 mL of 25% dextrose through infero-medial or infero-lateral approach will be done.\n2. extra-articular injections will be done at major tender tendons and ligaments through 15 skin punctures using peppering technique and placing a possible total of 22.5 mL of 25% dextrose.\n\n * Both intra and extra-articular injections will be done at 1, 5, 9, and 13 weeks intervals.\n\nFollow up will be done at 24 weeks after the last injection both clinically and ultrasonographically .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate and moderate to severe primary Knee osteoarthritis (KL grade II and III)\n* consent obtained\n\nExclusion Criteria:\n\n* Early Knee osteoarthritis (KL grade I)\n* Severe Knee osteoarthritis (KL grade IV)\n* Causes of 2ry osteoarthritis: other rheumatological, metabolic and inflammatory joint diseases.\n* received oral or systemic steroids 1 year prior to the procedure\n* received intra-articular steroids or hyaluronic acid 1 year prior to the procedure\n* BMI \\>45Kg/m2\n* poorly controlled diabetes mellitus, on anticoagulation therapy, history of cancer'}, 'identificationModule': {'nctId': 'NCT04178304', 'briefTitle': 'Effect of Prolotherapy in Knee Osteoarthritis.', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Effect of Prolotherapy in Knee Osteoarthritis: Clinical and Ultrasonographic Study.', 'orgStudyIdInfo': {'id': '0201167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'G1 patients receive prolotherapy', 'description': 'Intra and extra articular dextrose 25%', 'interventionNames': ['Drug: Prolotherapy with 25% Dextrose']}], 'interventions': [{'name': 'Prolotherapy with 25% Dextrose', 'type': 'DRUG', 'otherNames': ['25% dextrose intra and extra-articilar injection'], 'description': 'Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose', 'armGroupLabels': ['G1 patients receive prolotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00123', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University, Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Yousra H Abdel-Fattah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Medicine, Rheumatology and Rehabilitation', 'investigatorFullName': 'Yousra Hisham Abdel Fattah', 'investigatorAffiliation': 'University of Alexandria'}}}}