Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05595720
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2022-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D012783', 'term': 'Shoulder Dislocation'}, {'id': 'D004204', 'term': 'Joint Dislocations'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-23', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PAIN score', 'timeFrame': '1 MONTH', 'description': 'McGill pain questioner scale, scoring from zero to 78 zero is the best score seventy eight is the worst score'}, {'measure': 'FUNCTION', 'timeFrame': '1 MONTH', 'description': 'UCLA shoulder score from zero to 35 zero is the worst 35 is the best'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke,', 'Shoulder dysfunction', 'High intensity laser'], 'conditions': ['Stroke', 'Shoulder Dislocation or Subluxation']}, 'descriptionModule': {'briefSummary': 'Hemiplegic shoulder pain (HSP) is a common and disabling complication following a stroke, and it may affect the quality of life. It often occurs following two to three months of stroke. Upper limb impairment is seen in 90% of patients affected by stroke.\n\nNumerous causes have been implicated in developing HSP in stroke. This includes muscle flaccidity around the shoulder joint, shoulder subluxation, shoulder-hand syndrome, increased muscle tone, impingement syndrome, frozen shoulder, brachial plexus injury, and the thalamic syndrome.\n\nMuscle paresis, abnormal muscle tone and loss of proprioception following stroke may render the shoulder complex unstable and therefore prone to misalignment.\n\nIn recent years, high-intensity laser therapy (HILT) has been considered as a treatment option for shoulder pain.\n\nHILT increases microcirculation and tissue regeneration and lowers edema, inflammation, and pain with its photomechanical, thermal, electrical, and bio stimulating effects in deep tissues that cannot be reached with LILT.\n\nIt has some advantages over LILT, i.e., having higher power, greater tissue penetration capacity to deep tissues, the short emission time, and long rest periods preventing heat accumulation.\n\nIn recent studies, effectiveness of HILT has been shown in the treatment of subacromial impingement syndrome, rotator cuff tendinopathy, and frozen shoulder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DISORDER MORE THAN 6 MONTHS\n* UNILATERAL\n* FIRST TIME\n\nExclusion Criteria:\n\n* Iinflammatory rheumatic disease,\n* cervical radiculopathy,\n* diabetes mellitus,\n* thyroid disease,\n* coronary heart disease,\n* cardiac pacemaker,\n* neurological disease,\n* shoulder surgery, and\n* shoulder injection in the last 3 months'}, 'identificationModule': {'nctId': 'NCT05595720', 'briefTitle': 'Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Deraya University'}, 'officialTitle': 'Effect of High Intensity Laser on Hemiplegic Shoulder Dysfunction Double Blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'Deraya U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'interventionNames': ['Device: hight intenisty laser']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'hight intenisty laser', 'type': 'DEVICE', 'description': '7W(LAZR-207)/15W(LAZR-215\\&115)HIGH POWER LASER THERAPYUNIT WITH 2 WAVELENGTHMODES,COMBINATION(810+980 NM) AND SINGLE(1064 NM)', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05673', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Physical Therapy', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deraya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}