Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT02930551
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2016-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromas as the Cause of Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D009463', 'term': 'Neuroma'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2016-09-23', 'studyFirstSubmitQcDate': '2016-10-10', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spontaneous pain on numerical rating scale (NRS 0-10)', 'timeFrame': '15 minutes after injection', 'description': 'The participant will be asked about spontaneous pain'}, {'measure': 'Evoked pain on numerical rating scale (NRS 0-10)', 'timeFrame': '15 minutes after injection'}], 'secondaryOutcomes': [{'measure': 'Brush allodynia', 'timeFrame': '15 minutes after injection', 'description': 'Assesment of area (cm\\^2) using a SOMEDIC brush'}, {'measure': 'Pinprick hyperalgesia', 'timeFrame': '15 minutes after injection', 'description': 'Assesment of area (cm\\^2) using a von Frey filament (60 g)'}, {'measure': 'Cold allodynia', 'timeFrame': '15 minutes after injection', 'description': 'Assesment of area (cm\\^2) using a roll (20 degrees celcius)'}, {'measure': 'Heat allodynia', 'timeFrame': '15 minutes after injection', 'description': 'Assesment of area (cm\\^2) using a roll (40 degrees celcius)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neuropathic Pain', 'Neuroma']}, 'descriptionModule': {'briefSummary': 'Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with peripheral nerve injury 3 months prior to participation\n\nExclusion Criteria:\n\n* Severe somatic or psychiatric diseases\n* Other peripheral neuropathy\n* Lack of ability to cooperate to the clinical examination\n* Allergy to Lidocaine or similar analgetics'}, 'identificationModule': {'nctId': 'NCT02930551', 'briefTitle': 'Neuromas as the Cause of Pain', 'organization': {'class': 'OTHER', 'fullName': 'Danish Pain Research Center'}, 'officialTitle': 'Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study', 'orgStudyIdInfo': {'id': 'Neurom2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Lidocaine 2 ml injection with 2% Adrenaline', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Isotonic Saline', 'description': 'Isotonic Saline 2 ml Injection', 'interventionNames': ['Drug: Isotonic Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine']}, {'name': 'Isotonic Saline', 'type': 'DRUG', 'armGroupLabels': ['Isotonic Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Danish Pain Research Center, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Pain Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}