Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-20 @ 10:11 PM
Study NCT ID:
NCT02203994
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2014-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2014-07-28', 'studyFirstSubmitQcDate': '2014-07-29', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of spasticity', 'timeFrame': 'time 0, time 2h', 'description': 'Ashworth Scale'}], 'secondaryOutcomes': [{'measure': 'personal goal attainment', 'timeFrame': 'at day 0, 1, 3 and 5', 'description': 'Goal Attainment Scale'}, {'measure': 'walking speed', 'timeFrame': 'difference between pre- and post-intervention', 'description': '10 Meters Walking Test'}, {'measure': 'walking distance', 'timeFrame': 'difference between pre- and post-intervention', 'description': '6 Minutes Walking Test'}, {'measure': 'thickness of the treated muscle', 'timeFrame': 'difference between pre- and post-intervention', 'description': 'thickness measurement of the treated muscle using ultrasound'}, {'measure': 'severity of spasticity', 'timeFrame': 'time 0, time 2h', 'description': 'Adductor Tone Rating Scale'}, {'measure': 'severity of spasticity', 'timeFrame': 'time 0, time 2h', 'description': 'Penn Spasm Frequency Scale'}, {'measure': 'severity of spasticity', 'timeFrame': 'time 0, time 2h', 'description': 'Clonus Scale'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['extracorporal shock wave therapy (ESWT)', 'spasticity', 'spinal cord injury'], 'conditions': ['Spinal Cord Injury', 'Spasticity']}, 'descriptionModule': {'briefSummary': 'Spasticity is the most problematic self-reported secondary medical problem in patients with spinal cord injury. It has the potential to negatively influence quality of life through restricting activities of daily living. Problematic spasticity can cause pain and fatigue, disturb sleep, contribute to the developement of contractures and pressure ulcers, and has a negative effect on patients morbidity. For this reason there is enormous interest in therapeutic interventions addressing to decrease spasticity in persons with spinal cord injury. Recently, studies reported positive effects of extracorporeal shock wave therapy on spasticity in patients with stroke, focal limb dystonia and cerebral palsy. To date, no studies are published, assessing the effect of extracorporeal shock wave therapy on focal spasticity in patients with spinal cord injury.\n\nThe purpose of this study is to investigate the effect of a one-time ESWT on lower limb spasticity in patients with an incomplete spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic or non traumatic spinal cord injury\n* Minimum age: 18 years\n* Minimum time since spinal cord injury: two years\n* Lesion: C3-Th10\n* American Association of Spinal Cord Injury Impairment Score C and D\n* Focal spasticity in the adductor muscles and/ or triceps surae\n* Ability to walk 14 meters\n* Spasticity/clonus/spasms disturbing the activities of daily living or participation\n\nExclusion Criteria:\n\n* Changes in spasticity medication during the last 3 months\n* Treatment with botulinum toxin during the last 6 months\n* Anticoagulant medication\n* Thrombosis\n* Malignant tumors\n* Pregnancy\n* Inflammations or skin lesions in the treated area\n* Acute urinary tract infection\n* Intended change in spasticity medication within 5 days after intervention'}, 'identificationModule': {'nctId': 'NCT02203994', 'acronym': 'ESWT', 'briefTitle': 'Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Spasticity in Persons With Spinal Cord Injury', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'The Effect of Extracorporeal Shock Wave Therapy (ESWT) on Lower Limb Spasticity in Persons With an Incomplete Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2014-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'extracorporeal shock wave therapy (ESWT)', 'description': 'one-time treatment of the spastic muscle/ spastic muscles (adductor muscles and/ or M. triceps surae) with extracorporeal shock wave therapy (device: Duolith® SD 1 "T-Top" (Storz Medical AG, Tägerwilen, Switzerland))', 'interventionNames': ['Device: Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)']}], 'interventions': [{'name': 'Duolith® SD 1 "T-Top" (Storz Medical AG, Switzerland)', 'type': 'DEVICE', 'description': '2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz', 'armGroupLabels': ['extracorporeal shock wave therapy (ESWT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6207', 'city': 'Nottwil', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'Swiss Paraplegic Centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Michael Baumberger, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}