Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT03415360
Status:
UNKNOWN
Last Update Posted:
2018-09-25
First Post:
2018-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryolesion in Treatment of Phantom Limb Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010591', 'term': 'Phantom Limb'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2018-01-13', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of pain', 'timeFrame': 'T1: before cryoablation; T2: 24 hours after cryoablation; T3: 7 days after cryoablation; T4: 30 days after cryoablation; T5: 3 months after cryoablation; T6: 6 months after cryoablation.', 'description': 'Assessment of pain intensity pre- and post - cryoablation on the NRS (numeric rating scale).\n\nNumeric Rating Scale (NRS) is a unidimensional measure of pain intensity in adults. This is a 11-point numeric scale ranges from \'0\' (minimum, "no pain") to \'10\' (maximum, "pain as bad as one can imagine"). The lower the NRS value, the better clinical outcome.'}], 'secondaryOutcomes': [{'measure': 'The quality of life (SF-36)', 'timeFrame': 'A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.', 'description': 'Assessment of the quality of life pre- and post - cryoablation on SF-36. 36-Item Short Form Survey (SF-36) is a 36-item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.\n\nFor each of the eight domains that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning).'}, {'measure': 'The quality of life (AIS)', 'timeFrame': 'A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.', 'description': "Assessment of the quality of life pre- and post - cryoablation on AIS. The Acceptance of Illness Scale (AIS) consists of eight statements describing negative impact of poor health status and its consequences for patients' functioning. The scoring for each statement varies from 1 (poor adaptation to the disease) to 5 (full acceptance of the disease). The total score ranges between 8 and 40. The lower score, the poorer acceptance of disease and more severe restrictions caused by condition. A high score means acceptance of patient's own health status and lack of negative emotions related to illness."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cryoablation'], 'conditions': ['Phantom Limb Pain', 'Stump Neuralgia', 'Pain, Phantom']}, 'descriptionModule': {'briefSummary': 'Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.\n\nReassessment of pain intensity on the NRS 30 minutes after local anesthetic block.\n\nCryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.\n\nIf pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.\n\nCryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.\n\nIf pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.\n\nCryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.\n\n* 24 hours after the procedure - assessment of pain intensity and quality of life\n* 7 days after the procedure - assessment of pain intensity\n* 30 days after the procedure - assessment of pain intensity and quality of life\n* 3 months after the procedure - assessment of pain intensity\n* 6 months after the procedure - assessment of pain intensity and quality of'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Status post amputation of a lower or upper limb\n* Pain related to amputation as determined by referring physician and investigator\n* Informed consent of patient to enter the study\n* Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure\n\nExclusion Criteria:\n\n* Pregnancy\n* Active infection in the area of the planned intervention\n* Blood coagulation disorders\n* Immunosuppression\n* Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures\n* Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation\n* Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.\n* No reduction of pain after the diagnostic block of the relevant main peripheral nerves'}, 'identificationModule': {'nctId': 'NCT03415360', 'briefTitle': 'Cryolesion in Treatment of Phantom Limb Pain', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation', 'orgStudyIdInfo': {'id': '681006-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'cryoablation', 'description': 'peripheral nerve cryoablation', 'interventionNames': ['Procedure: cryoablation']}], 'interventions': [{'name': 'cryoablation', 'type': 'PROCEDURE', 'description': 'cryoablation of nerve responsible for phantom limb pain', 'armGroupLabels': ['cryoablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04141', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Jaroslaw Les, MD, PhD', 'role': 'CONTACT', 'email': 'jles@wim.mil.pl', 'phone': '+48 216816895'}], 'facility': 'Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Dariusz Tomaszewski, MD PhD', 'role': 'CONTACT', 'email': 'dtomaszewski@wim.mil.pl', 'phone': '00 48501 190 386'}, {'name': 'Jaroslaw J Les, MD PhD', 'role': 'CONTACT', 'email': 'jles@wim.mil.pl', 'phone': '00 48 695 926 026'}], 'overallOfficials': [{'name': 'Dariusz Tomaszewski', 'role': 'STUDY_CHAIR', 'affiliation': 'Military Institute of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct professor', 'investigatorFullName': 'Dariusz Tomaszewski', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}