Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-01 @ 8:30 AM
Study NCT ID:
NCT04731350
Status:
COMPLETED
Last Update Posted:
2023-03-07
First Post:
2021-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shock Wave Versus Iontophoresis in Treatment of Subjects With 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': 'D007478', 'term': 'Iontophoresis'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004586', 'term': 'Electrophoresis'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-05', 'studyFirstSubmitDate': '2021-01-16', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale (VAS)', 'timeFrame': 'change from baseline to immediately pre treatment and from pre treatment to immediately post treatment', 'description': 'pain intensity will be assessed by using visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'knee range of motion (ROM)', 'timeFrame': 'change from baseline to immediately pre treatment and from pre treatment to immediately post treatment', 'description': 'electronic geniometer'}, {'measure': 'knee injury and osteoarthritis outcome score physical function short (KOOS-PS)', 'timeFrame': 'change from baseline to immediately pre treatment and from pre treatment to immediately post treatment', 'description': 'knee function by using KOOS-PS questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this study was to investigate and compare between the effect of shock wave and iontophoresis in treatment of knee osteoarthritis . it was hypothesized that there will be no difference between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.', 'detailedDescription': '60 subjects with grade II knee osteoarthritis will be recruited from outpatient clinic of faculty of physical therapy and then they will be assigned randomly by sealed envelope into three groups ;group A (shock wave group) will received radial extracorporeal shock wave ,group B (Iontophoresis group ) will receive deaxamthasone iontophoresis and group c (control group) will receive traditional tratment ( stregnthening exerciseces) all treatment will be once session per week for four weeks .pain intensity ,knee ROM and knee injury and osteoarthritis outcome score physical function short (KOOS-PS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic knee OA for at least 3 months according to clinical criteria of American College of Rheumatology\n2. Radiologic findings had to be compatible with knee OA, with kelgren and Lawrence (K-L) grade 2 in a simple X ray .\n3. Tenderness on medial tibial plateau\n4. Intensity of pain: visual analogue scale equal to 5 or greater\n5. Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others)\n\nExclusion Criteria:\n\n1. Neuorological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months\n2. Any contraindication to magnetic resonance imaging or radiography, or trauma history on knee\n3. history of previous knee surgery -'}, 'identificationModule': {'nctId': 'NCT04731350', 'acronym': 'Shockwave', 'briefTitle': 'Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Extra Corporeal Shock Wave Versus Dexamethasone Iontophoresis in Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'REC/012/002633'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shock wave(A)', 'description': 'subjects will recive radial extracorporeal shock wave (2000 shock/session, 10Hz and EFD 0.178 mJ/mm²) on knee joints once per week for four weeks in addition to strengthening exercise', 'interventionNames': ['Device: radial extracorporeal shock wave', 'Other: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Iontophoresis (B)', 'description': 'subjects will recive dexamethasone iontophoresis on knee joints once per week for four weeks in addition to strengthening exercise', 'interventionNames': ['Device: iontophoresis', 'Other: Exercise']}, {'type': 'OTHER', 'label': 'Control (C)', 'description': 'stregnthening exercise;straight leg raising exercisein which the patients were positioned in the crook lying position with the unexercised limb was the flexed one then the patients were asked to contract the quadriceps muscle and elevate the limb to 45º and hold for 6 seconds, slowly lower the limb and then relax for 6 seconds, three sets of 10 repetitions were don ,Isometric quadriceps contraction (quadriceps drill) in full knee extension maintained for 5 seconds, followed by a 5-second rest; the exercise was performed for 20 repetitions per session .treatment once per week for four weeks', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'radial extracorporeal shock wave', 'type': 'DEVICE', 'description': 'Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)', 'armGroupLabels': ['Shock wave(A)']}, {'name': 'iontophoresis', 'type': 'DEVICE', 'description': 'Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):', 'armGroupLabels': ['Iontophoresis (B)']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'strengthening exercise', 'armGroupLabels': ['Control (C)', 'Iontophoresis (B)', 'Shock wave(A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of physical therapy ,Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Shimaa Taha Abu El Kasem', 'investigatorAffiliation': 'Cairo University'}}}}