Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT04185194
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2019-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'sealed envelopes'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2019-11-15', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interleukin 6', 'timeFrame': 'three months', 'description': 'measurement of interleukin 6 cncentration in blood plasma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myofascial pain syndrome, pain quality'], 'conditions': ['Treatment Side Effects']}, 'descriptionModule': {'briefSummary': 'A topical anesthetic gel lidocaine has been widely used as a local anesthetic to reduce the pain and discomfort. It provides local analgesia by blocking the initiation and transmission of impulses. Lidocaine topical anesthetic gel allows the use of high concentrations of the anesthetic bases without concern about local irritation, uneven absorption or systemic toxicity (Argoff, 2000 ). So, the aim of this study is to compare between the effect of lidocaine phonophoresis and pulsed ultrasound in myofascial pain syndrome in swimmers children.', 'detailedDescription': 'Fourty five children (athletic swimmers) participated in this study, and were classified into three groups ; First control group A : this group consisted of fifteen children were receiving traditional physical therapy program. Second study group B: this group consisted of fifteen children were receiving pulsed ultrasound in addition to traditional physical therapy program as the same as in group A. Third study group C: this group consisted of fifteen children were receiving lidocaine phonophoresis in addition to traditional physical therapy program as the same as in group A. Treatment program in the three groups applied three times a week for three successive months. The study was done in the outpatient clinic of Ismailiy Sporting Club, Ismailia, Egypt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age range from 10 to 14 years.\n\n * All children have regional neck pain complaint.\n * Tenderness in cervical trigger points in the midpoint of the upper border of trapezius muscle, from grade II to grade IV according to tenderness grading scheme (Hubbard and Berkoff, 1993) (Appendix I ) ● The diagnosis of an active MTrP in the upper trapezius according to (Ardiçet al . , 2002 and Bruno, 2005)\n\nExclusion Criteria:\n\n* • Neurological disorders.\n\n * Dermatological disorders.\n * Acute trauma prior to the study.\n * Fibromyalgia, systemic disease and drug allergy history were excluded from the study.\n * Having myofascial trigger points injection.\n * Chronic pain in both sides of the body.'}, 'identificationModule': {'nctId': 'NCT04185194', 'acronym': 'PH', 'briefTitle': 'Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children', 'orgStudyIdInfo': {'id': 'P.T.REC/012/001708'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'received especially designed physical therapy program', 'interventionNames': ['Other: especially designed physical therapy program']}, {'type': 'EXPERIMENTAL', 'label': 'group b', 'description': 'received pulsed ultrasound in addition to physical therapy program', 'interventionNames': ['Drug: Lidocaine', 'Device: pulsed ultrasound', 'Other: especially designed physical therapy program']}, {'type': 'EXPERIMENTAL', 'label': 'group c', 'description': 'received lidocaine phonophoresis in addition to physical therapy program', 'interventionNames': ['Drug: Lidocaine', 'Device: pulsed ultrasound', 'Other: especially designed physical therapy program']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['lidocaine topical'], 'description': 'transmission of the drug molecules to the underlying muscles', 'armGroupLabels': ['group b', 'group c']}, {'name': 'pulsed ultrasound', 'type': 'DEVICE', 'description': 'using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain', 'armGroupLabels': ['group b', 'group c']}, {'name': 'especially designed physical therapy program', 'type': 'OTHER', 'description': 'by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius', 'armGroupLabels': ['group A', 'group b', 'group c']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12612', 'city': 'Giza', 'country': 'Egypt', 'facility': 'faculty of physical therapy,Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Asser Sallam, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Suez Canal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'results of the study design, abstract, conclusion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pediatric physical therapy specialist (master degree)', 'investigatorFullName': 'Mohamed abdel Moneim Abo El Roos', 'investigatorAffiliation': 'Cairo University'}}}}