Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-06-04 @ 6:55 PM
Study NCT ID:
NCT03251703
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2017-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Suprascapular Pulsed Radiofrequency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2017-08-13', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency', 'timeFrame': '1 years', 'description': 'Retroscopic study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PAIN, INTRACTABLE, Shoulder']}, 'descriptionModule': {'briefSummary': 'Shoulder pain is the second most common musculoskeletal disease in adults, and it often becomes chronic due to treatment difficulties.\n\nPulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of chronic shoulder pain due to its long duration of action and non-destructive method.', 'detailedDescription': 'These patients lacked pain control despite systemic analgesics and conservative therapy and applied to our pain polyclinics for shoulder pain lasting at least 3 months.\n\nThe ultrasound-guided SSPRF was performed in those patients with a reduction of 50% or more VAS score and those that reported healing in the AROM in the diagnostic SNB.\n\nThe resting, motion and sleeping shoulder pain assessments of the patients were done using a visual analog scale (VAS). The shoulder joint function was assessed using the Shoulder Pain and Disability Index (SPADI) questionnaire and the active range of motion (AROM) of the joint was measured using a goniometer In this study, investigators aimed to reveal the effects of ultrasound-guided suprascapular PRF (SSPRF) therapy applied to patients with chronic shoulder pain on both shoulder pain and function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'shoulder pain lasting at least 3 months.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 18 years of age or older who were diagnosed with at least one of the following: adhesive capsulitis of the shoulder (M75.0), rotator cuff syndrome (M75.1), and impingement syndrome of shoulder (M75.4) according to the ICD-10 classifications. These patients lacked pain control despite systemic analgesics and conservative therapy (like physiotherapy) and applied to our pain polyclinics for shoulder pain lasting at least 3 months.\n\nExclusion Criteria:\n\nPatients with other diseases causing chronic pain, those with neuropathic pain, those who had undergone surgery on the same shoulder, those with an allergy history from local anesthesia, those with abnormal coagulation tests, and those with cardiac pacemakers were excluded from this study.'}, 'identificationModule': {'nctId': 'NCT03251703', 'acronym': 'PRF', 'briefTitle': 'Ultrasound-Guided Suprascapular Pulsed Radiofrequency', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Effects of Ultrasound-Guided Suprascapular Pulsed Radiofrequency Therapy on Chronic Shoulder Pain', 'orgStudyIdInfo': {'id': 'Sakaray University'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound-Guided Suprascapular Pulsed Radiofrequency .', 'type': 'PROCEDURE', 'description': 'The ultrasound-Guided Suprascapular Pulsed Radiofrequency was administered under operating room conditions while the patient was monitored in a sitting position.An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) was pushed forward towards the suprascapular notch until it passed the transverse scapular ligament using an in-plane approach.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Serbülent Gökhan BEYAZ', 'investigatorAffiliation': 'Sakarya University'}}}}