Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 3:25 AM
Study NCT ID:
NCT07485192
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2026-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-07', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Baseline, 1 month, and 3 months after treatment initiation.', 'description': 'The Visual Analog Scale will be used to assess the intensity of pain reported by participants. The scale consists of a 10-cm horizontal line anchored by two extremes: 0 = no pain and 10 = worst imaginable pain. Participants will mark the point on the line that best represents their pain intensity. The score will be determined by measuring the distance (in centimeters) from the "no pain" anchor to the participant\'s mark, with higher scores indicating greater pain intensity.'}], 'secondaryOutcomes': [{'measure': 'Shoulder range of motion', 'timeFrame': 'Baseline, 1 month, and 3 months after treatment initiation.', 'description': 'Maximum passive shoulder flexion, abduction, internal rotation, and external rotation, as well as the range of motion at pain onset, were measured using a goniometer while the patient was in the supine position. Measurements were recorded in degrees, and higher values indicate greater joint range of motion.'}, {'measure': 'Presence of supraspinatus tendon tear', 'timeFrame': 'Baseline, 1 month, and 3 months after treatment initiation.', 'description': 'The presence of a supraspinatus tendon tear was evaluated using ultrasonography with a branded ultrasound device. Imaging was performed by an experienced clinician.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemiplegic Shoulder Pain']}, 'referencesModule': {'references': [{'pmid': '27446789', 'type': 'BACKGROUND', 'citation': 'Kim SH, Ha KW, Kim YH, Seol PH, Kwak HJ, Park SW, Ryu BJ. Effect of Radial Extracorporeal Shock Wave Therapy on Hemiplegic Shoulder Pain Syndrome. Ann Rehabil Med. 2016 Jun;40(3):509-19. doi: 10.5535/arm.2016.40.3.509. Epub 2016 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) with conventional treatment for hemiplegic shoulder pain. A total of 67 patients aged 45-70 years, treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were randomly assigned to three groups. The first group (n=24) received conventional treatment, the second group (n=22) received conventional treatment plus one session of ultrasound-guided suprascapular nerve block, and the third group (n=21) received conventional treatment plus ESWT applied for 2 weeks, 4 days per week at 12 Hz and 2-3 bars. All groups were evaluated clinically and ultrasonographically before treatment, at 1 month, and at 3 months. Pain intensity was assessed using the visual analog scale, upper extremity motor function with the Fugl-Meyer Motor Scale, and supraspinatus muscle tear size via ultrasound.', 'detailedDescription': 'This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and suprascapular nerve block (SSNB) when added to conventional treatment in patients with hemiplegic shoulder pain.\n\nA total of 67 patients aged 45 to 70 years who were treated at the Department of Physical Therapy and Rehabilitation at Başakşehir Çam and Sakura City Hospital between April 1, 2023, and January 1, 2024, were included in the study. Participants were randomly assigned into three groups. The first group (n = 24) received conventional treatment alone. The second group (n = 22) received conventional treatment combined with a single session of ultrasound-guided suprascapular nerve block (SSNB). The third group (n = 21) received conventional treatment combined with extracorporeal shock wave therapy (ESWT), applied for two weeks, four days per week, at a frequency of 12 Hz and an intensity of 2 to 3 bars.\n\nAll participants were evaluated clinically and ultrasonographically at baseline, at one month, and at three months. Pain intensity was assessed using the Visual Analog Scale (VAS). Upper extremity motor function was evaluated using the Fugl-Meyer Motor Scale (FMMS). Supraspinatus muscle tear size was measured using ultrasonography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with hemorrhagic or ischemic stroke at least 3 months prior to enrollment.\n\nPatients with shoulder pain of at least 5 cm on the 10-cm Visual Analog Scale (VAS) following hemiplegia.\n\nPatients aged 45-70 years.\n\nPatients with partial tear of the supraspinatus muscle/tendon confirmed by ultrasonographic evaluation.\n\nExclusion Criteria:\n\n* Patients with limited cooperation.\n\nPatients who received local anesthetic or corticosteroid injection to the shoulder region within the last 3 months.\n\nPatients with a history of surgery or radiotherapy in the shoulder region.\n\nPatients with pre-existing shoulder pain prior to the diagnosis of stroke.\n\nPatients with a cardiac pacemaker.\n\nPatients with malignancy or signs of acute inflammation in the treatment area.\n\nPatients with coagulation disorders or an INR ≥ 4.\n\nPatients with vascular conditions such as deep vein thrombosis, phlebitis, varicose veins, or arterial disease.'}, 'identificationModule': {'nctId': 'NCT07485192', 'acronym': 'ESWT-HSP', 'briefTitle': 'Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kars State Hospital'}, 'officialTitle': 'Comparison of the Efficacy of Extracorporeal Shock Wave Therapy and Suprascapular Nerve Block in Hemiplegic Shoulder Pain', 'orgStudyIdInfo': {'id': '2023.02.49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Treatment', 'description': 'Participants received conventional therapy including transcutaneous electrical nerve stimulation, hot pack therapy and joint range of motion, stretching, and progressive resistive exercises', 'interventionNames': ['Other: Conventional therapy group']}, {'type': 'EXPERIMENTAL', 'label': 'Suprascapular Nerve Block plus Conventional Treatment', 'description': 'Participants received one session of ultrasound-guided suprascapular nerve block prior to conventional therapy, followed by the same conventional treatment protocol.', 'interventionNames': ['Procedure: suprascapular nerve block']}, {'type': 'EXPERIMENTAL', 'label': 'ESWT plus Conventional Treatment', 'description': 'Participants received extracorporeal shock wave therapy in addition to the conventional treatment protocol.', 'interventionNames': ['Device: Extracorporeal Shock Wave Therapy']}], 'interventions': [{'name': 'Conventional therapy group', 'type': 'OTHER', 'description': 'Conventional treatment including transcutaneous electrical nerve stimulation, hot pack therapy for 4 weeks, and joint range of motion, stretching, and progressive resistive exercises performed 5 days per week for 12 weeks.', 'armGroupLabels': ['Conventional Treatment']}, {'name': 'suprascapular nerve block', 'type': 'PROCEDURE', 'description': 'A single session of ultrasound-guided suprascapular nerve block administered prior to the conventional therapy program.', 'armGroupLabels': ['Suprascapular Nerve Block plus Conventional Treatment']}, {'name': 'Extracorporeal Shock Wave Therapy', 'type': 'DEVICE', 'description': 'Extracorporeal shock wave therapy applied at 12 Hz frequency and 2-3 bars pressure, 4 days per week for 2 weeks, in addition to the conventional therapy program.', 'armGroupLabels': ['ESWT plus Conventional Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Başakşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Başakşehir Çam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'özge özpolat bulut', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kanuni Sultan Süleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kars State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fatih Bagcier', 'investigatorAffiliation': 'Kars State Hospital'}}}}