Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-03 @ 5:14 PM
Study NCT ID:
NCT01073956
Status:
UNKNOWN
Last Update Posted:
2011-07-07
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Electrotherapy in Subacromial Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}], 'ancestors': [{'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-06', 'studyFirstSubmitDate': '2010-02-22', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of pain intensity', 'timeFrame': '12 sessions (1 month)', 'description': 'Evaluation after 12 sessions of intervention (1 month)'}], 'secondaryOutcomes': [{'measure': 'Variation at pain intensity', 'timeFrame': '18 sessions (1.5 months)', 'description': 'Evaluation at 1.5 months'}, {'measure': 'Variation at pain intensity', 'timeFrame': '6 months after intervention', 'description': 'Follow-up evaluation'}]}, 'conditionsModule': {'keywords': ['Subacromial Impingement Syndrome', 'Shoulder Pain', 'Physical therapy', 'Electrotherapy', 'Ultrasonic therapy', 'Medium-wave 448 kHz therapy'], 'conditions': ['Shoulder Impingement Syndrome']}, 'referencesModule': {'references': [{'pmid': '12804509', 'type': 'BACKGROUND', 'citation': 'Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of electrotherapy as a coadjuvant in mobility and exercise treatment in the reduction of pain intensity in subacromial impingement syndrome.', 'detailedDescription': "Among the different diagnoses covered by the concept of shoulder pain, the most common is subacromial impingement syndrome, which represents 44%-60% of the total.Specific supervised exercises obtain improvements in the range of movement and muscular function by restoring the shoulder's mobility and stability. Physiotherapeutic options include several electrotherapy techniques.\n\nUltrasound is no more beneficial than exercise alone. Likewise, the results of some more recent studies evaluating the application of ultrasound alone versus placebo, showed that ultrasound alone in physiotherapy treatment of shoulder pain is only effective in patients with calcific tendonitis of the shoulder. All the authors, however, suggest that effectiveness can vary, depending on application conditions, dosage and timing.\n\nThe primary objective of the trial is to analyze the efficacy of electrotherapy treatment (monopolar radiofrequency or ultrasound) coadjuvant to mobility and exercise therapy in the reduction of pain intensity in subacromial impingement syndrome.\n\nThe secondary objectives of this study are to determine the differences between three intervention groups: monopolar radiofrequency, ultrasound and inactive radiofrequency, in improvement of performance status, quality of life and global impression of improvement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women over 18 years of age\n* Shoulder pain secondary to subacromial impingement syndrome\n* Pain at rest and/or with free movement and/or with movement against resistance with a score on the visual analogue scale of 3 or higher.\n* Documented X-ray (XR), ultrasound (US) and/or magnetic resonance imaging (MRI) evidence of cuff injury involving oedema, tendonitis, fibrosis or torn tendon.\n* Potentially available for the next six months.\n\nExclusion Criteria:\n\n* Documented US and/or MRI evidence of complete tearing of the cuff and clinical inability to lift the arm (drop arm sign)\n* Radiological findings of tumour lesions, avascular necrosis, glenoid development defects, acromial bone, severe degenerative signs affecting inter-articular space and fractures\n* Limited range of passive movement with capsular pattern\n* Recent history of trauma (contusion, falls or sudden jarring)\n* Ischaemic cardiopathy in subacute phase\n* History of more than five infiltrations and/or shoulder surgery\n* History of rehabilitation treatment for the same reason in the last 12 months\n* Cognitive deficit, psychiatric alterations or behavioural disorders that might compromise the patient's collaboration\n* Unsuitable for electrotherapy: pregnancy, epilepsy, pacemaker, osteosynthesis, undergoing treatment with Sintrom\n* Patients in litigation or in the process of making work-related claims\n* Failure to understand Spanish"}, 'identificationModule': {'nctId': 'NCT01073956', 'briefTitle': 'Efficacy of Electrotherapy in Subacromial Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Fundacio Espai Salut'}, 'officialTitle': 'Efficacy of Electrotherapy in Subacromial Impingement Syndrome: Randomised Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'FES-2009-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Inactive electrotherapy', 'description': 'Inactive electrotherapy is applied to the painful points', 'interventionNames': ['Procedure: Inactive electrotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound', 'description': 'Ultrasound electrotherapy is applied to the painful points', 'interventionNames': ['Procedure: Ultrasonic therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monopolar radiofrequency', 'description': 'Monopolar radiofrequency electrotherapy is applied to the painful points', 'interventionNames': ['Procedure: Medium-wave 448 kHz therapy']}], 'interventions': [{'name': 'Medium-wave 448 kHz therapy', 'type': 'PROCEDURE', 'otherNames': ['Monopolar radiofrequency'], 'description': '0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove', 'armGroupLabels': ['Monopolar radiofrequency']}, {'name': 'Ultrasonic therapy', 'type': 'PROCEDURE', 'otherNames': ['Ultrasound electrotherapy'], 'description': 'Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove', 'armGroupLabels': ['Ultrasound']}, {'name': 'Inactive electrotherapy', 'type': 'PROCEDURE', 'description': 'Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.', 'armGroupLabels': ['Inactive electrotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto de Rehabilitación Tres Torres -IR3T', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08037', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Centro de Recuperación Funcional (CRF)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Conxita Closa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporación Fisiogestión S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacio Espai Salut', 'class': 'OTHER'}, 'collaborators': [{'name': 'Corporación Fisiogestión S.A.', 'class': 'UNKNOWN'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': "Agència d'Avaluació de Tecnologia i Recerca Mèdiques", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Conxita Closa Rusinés', 'oldOrganization': 'Corporación Fisiogestión'}}}}