Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 8:00 PM
Study NCT ID:
NCT06825832
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2025-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency Of High Power Laser Versus Pulsed Electromagnetic Therapy On Hemiplegic Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-02-08', 'studyFirstSubmitQcDate': '2025-02-08', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder range of motion', 'timeFrame': '4 weeks', 'description': 'BY DIGITAL GONIOMETER'}, {'measure': 'shoulder pain by visual analogue scale (VAS)', 'timeFrame': '4 weeks', 'description': 'It will be used to measure pain intensity for each participant in 3 groups (A, B and C). The VAS is usually presented as a 10 cm horizontal line on which the participants\' pain intensity is represented by a point between the extremes of "no pain at all "and "worst pain imaginable . zero means no pain ,ten means worst pain.'}, {'measure': 'shoulder pain and disability', 'timeFrame': '4 weeks', 'description': 'by Shoulder Pain and Disability Index (SPADI)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemiplegic Shoulder Pain', 'Laser Therapy', 'Pulsed Electromagnetic Therapy']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to determine the effectiveness of high-power laser and pulsed electromagnetic field on hemiplegic shoulder pain', 'detailedDescription': "One common problem that often manifests two weeks to two months following a stroke is shoulder pain. It adversely impacts patients' quality of life and hinders their ability to regain motor and sensory function. Psychological alterations and sleep problems, such as depression, anxiety, hypervigilance, fear avoidance, pain catastrophizing, trouble falling asleep, and early awakening, can also occure.\n\nThe majority of HSP develop in the first 2 weeks up to 6 months and about 65% of those will continue to experience the problem several months after that .\n\nThe actual cause of HSP is uncertain and frequently complex. So far, numerous pathogenic processes have been found that are likely to be associated to HSP: Joint subluxation, adhesive capsulitis, complex regional pain syndrome, rotator cuff injury, spasticity, and other conditions .\n\nIn the last few decades, an enormous number of treatment options have been developed due to the multiple etiology of HSP, But there is still a great deal of uncertainty regarding their efficacy because several etiologies probably lead to the same problem .\n\nHigh power laser therapy is one suggested therapeutic option for shoulder pain HPLT has long been used to treat conditions that low power laser therapy (LPLT) cannot, such as increased microcirculation, accelerated tissue regeneration, decreased swelling, inflammation, and pain, because of its photomechanical, thermal, electrical and bio stimulating effects on deep tissues. Benefits of HPLT over LPLT include higher power, deeper tissue penetration, shorter emission durations, and longer rest intervals that avoid heat buildup.\n\nIt is hypothesized that compared to single-wavelength low-level laser therapy (LLLT), Multiwave Locked System (MLS) allows for better penetration and therapeutic efficacy .\n\nMagnetic field therapy enhances local cellular activity, organizes collagen fibers, enhances oxygen use in tissues, and speeds up circulation by enhancing blood vessel vasodilation without raising local temperatures but There is insufficient evidence supporting its efficacy and superiority to physical therapy agents .\n\nTo our knowledge this is the first study to determine the efficiency of high-power laser and pulsed electromagnetic field on hemiplegic shoulder pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. HSP patients aged 40-65 years.\n2. unilateral hemiplegia for the first time.\n3. duration of stroke of more than 6 months.\n4. Visual Analogue Scale (VAS) of more than 4.\n5. patients with 1-3 degrees of spasticity according to Modified Ashworth Scale (MAS).\n\nExclusion Criteria:\n\n1. Patients with a history of inflammation-related rheumatic disease\n2. cervical radiculopathy\n3. cardiovascular disease or cardiac pacemakers\n4. uncontrolled siezures or sever arrthymia\n5. shoulder operations, or shoulder injection during the previous three months were excluded.'}, 'identificationModule': {'nctId': 'NCT06825832', 'briefTitle': 'Efficiency Of High Power Laser Versus Pulsed Electromagnetic Therapy On Hemiplegic Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficiency of High Power Laser Versus Pulsed Electromagnetic Therapy on Hemiplegic Shoulder Pain', 'orgStudyIdInfo': {'id': 'laser + electromagnetic field'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'INTERVENTION 1 LASER', 'description': 'The MLS® Laser Therapy device used in this study is M6 (ASA srl -Arcugnano, Italy), equipped with both a robotized multidiode head (up to 3,3W), able to perform automatic scanning treatments, and an MLS® handpiece (up to 1,1W), aimed to perform manual point to point or scanning treatments. Each treatment includes two stages: the scanning of the frontal and dorsal shoulder area of 93 cm2 each with a robotized multidiode head and a point-by-point process with the manual handpiece with 7 points of 3,14 cm2 area. 3 sessions per week for 4 weeks', 'interventionNames': ['Device: high power laser therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INTERVENTION 2 PEMFT', 'description': "the PEMF application, with application of low intensity and frequency pulsed electromagnetic fields (PEMF), the portable device PMT QS (ASA Srl, Arcugnano) is used, equipped with Flexa applicators (36 x 21 x 2 cm (L x P x H) - 1.2 kg), programmable frequency from 0.5 to 100 Hz and variable magnetic field intensity from 5% to 100% (from \\~2.5 to \\~40 Gauss)), two solenoid applicators are placed at the anterior and posterior positions in the patient's shoulders and applied for 25 min at 25 G intensity at a frequency of 50 Hz.3 sessions per week for 4 weeks", 'interventionNames': ['Device: pulsed electromagnetic field therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INTERVENTION 3 EXERCISE', 'description': 'The conventional exercise program for hemiplegic shoulder pain (HSP) is stretching exercise therapy, joint stabilization exercise therapy.3 sessions per week for 4 weeks', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'high power laser therapy', 'type': 'DEVICE', 'description': 'The MLS® Laser Therapy device used in this study is M6 (ASA srl -Arcugnano, Italy), equipped with both a robotized multidiode head (up to 3,3W), able to perform automatic scanning treatments, and an MLS® handpiece (up to 1,1W), aimed to perform manual point to point or scanning treatments. Each treatment includes two stages: the scanning of the frontal and dorsal shoulder area of 93 cm2 each with a robotized multidiode head and a point-by-point process with the manual handpiece with 7 points of 3,14 cm2 area.', 'armGroupLabels': ['INTERVENTION 1 LASER']}, {'name': 'pulsed electromagnetic field therapy', 'type': 'DEVICE', 'description': "the PEMF application, with application of low intensity and frequency pulsed electromagnetic fields (PEMF), the portable device PMT QS (ASA Srl, Arcugnano) is used, equipped with Flexa applicators (36 x 21 x 2 cm (L x P x H) - 1.2 kg), programmable frequency from 0.5 to 100 Hz and variable magnetic field intensity from 5% to 100% (from \\~2.5 to \\~40 Gauss)), two solenoid applicators are placed at the anterior and posterior positions in the patient's shoulders and applied for 25 min at 25 G intensity at a frequency of 50 Hz.", 'armGroupLabels': ['INTERVENTION 2 PEMFT']}, {'name': 'Exercise', 'type': 'OTHER', 'description': 'The conventional exercise program for hemiplegic shoulder pain (HSP) is stretching exercise therapy, joint stabilization exercise therapy.', 'armGroupLabels': ['INTERVENTION 3 EXERCISE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Giza', 'state': 'Ad Doqi', 'country': 'Egypt', 'facility': 'Cairo Uni', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Eman Samir Fayez, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'faculty of physical therapy cairo uni'}, {'name': 'Ahmed Karmallaah Mohamed, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of medicine cairo uni'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PRINCIPLE INVESTIGATOR', 'investigatorFullName': 'Ahmed Mohamed Elsayed', 'investigatorAffiliation': 'Cairo University'}}}}