Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-03-04 @ 7:57 PM
Study NCT ID:
NCT02467556
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2015-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-28', 'releaseDate': '2021-04-03'}, {'resetDate': '2024-02-02', 'releaseDate': '2023-05-30'}], 'estimatedResultsFirstSubmitDate': '2021-04-03'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D008559', 'term': 'Memantine'}, {'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2015-06-08', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Direction of change in patient reported CRPS symptom discriptors', 'timeFrame': 'Three months', 'description': 'Reports of CRPS symptoms'}], 'secondaryOutcomes': [{'measure': 'Direction of change in motor parameters', 'timeFrame': 'Three months', 'description': 'Measurements of strength of the hand, the active range of motion in the hand/arm, 9HPT, DASH questionnaire'}, {'measure': 'Direction of change in psychological parameters', 'timeFrame': 'Three months', 'description': 'Patient scores in BDI, PASS-20, CPAQ'}, {'measure': 'Direction of change in quality of life', 'timeFrame': 'Three months', 'description': 'Patient scores in 15D'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CRPS', 'intervention', 'multimodal'], 'conditions': ['CRPS']}, 'referencesModule': {'references': [{'pmid': '24530407', 'type': 'BACKGROUND', 'citation': 'Bean DJ, Johnson MH, Kydd RR. The outcome of complex regional pain syndrome type 1: a systematic review. J Pain. 2014 Jul;15(7):677-90. doi: 10.1016/j.jpain.2014.01.500. Epub 2014 Feb 12.'}, {'pmid': '20630656', 'type': 'BACKGROUND', 'citation': 'Gustin SM, Schwarz A, Birbaumer N, Sines N, Schmidt AC, Veit R, Larbig W, Flor H, Lotze M. NMDA-receptor antagonist and morphine decrease CRPS-pain and cerebral pain representation. Pain. 2010 Oct;151(1):69-76. doi: 10.1016/j.pain.2010.06.022. Epub 2010 Jul 13.'}, {'pmid': '30789827', 'type': 'DERIVED', 'citation': 'Elomaa M, Hotta J, de C Williams AC, Forss N, Ayrapaa A, Kalso E, Harno H. Symptom reduction and improved function in chronic CRPS type 1 after 12-week integrated, interdisciplinary therapy. Scand J Pain. 2019 Apr 24;19(2):257-270. doi: 10.1515/sjpain-2018-0098.'}]}, 'descriptionModule': {'briefSummary': 'A ten week open label study intervention to evaluate the outcome for a psychological intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS patients.', 'detailedDescription': 'Ten CRPS I patients attended an intervention for 10 weeks. First, the medication was started with morphine 10mg adding gradually to 30 mg per day. Then, in addition to morphine, memantine 5 mg was started adding the dose gradually up to 40 mg per day if tolerated. Physiotherapy and psychological intervention were mostly carried out in a weekly group gathering with home exercises that were recorded to a diary. Psychological and physiotherapy interventions lasted for eight weeks. A neurological examination was done before and after the intervention as well as a separate physiotherapist examination of the hands. Patients filled out questionnaires of mood, quality of life, pain, and CRPS descriptions before and after the intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CRPS type 1 for at least 6 months,\n* pain NRS 4 or more\n\nExclusion Criteria:\n\n* major psychiatric or neurological disease'}, 'identificationModule': {'nctId': 'NCT02467556', 'acronym': 'MultiModCRPS', 'briefTitle': 'Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome', 'orgStudyIdInfo': {'id': 'Helsinki University Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'intervention', 'description': 'Open label study with psychological intervention and physiotherapy intervention with medication of morphine, memantine for ten weeks (morphine 30mg tbl per day and memantine up to 40mg tbl per day if tolerated).', 'interventionNames': ['Drug: Morphine, memantine', 'Behavioral: Psychological intervention', 'Other: Physiotherapy intervention']}], 'interventions': [{'name': 'Morphine, memantine', 'type': 'DRUG', 'otherNames': ['Depolan (morphine), Ebixa (memantine)'], 'description': 'Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.', 'armGroupLabels': ['intervention']}, {'name': 'Psychological intervention', 'type': 'BEHAVIORAL', 'description': 'To help patients shift perspective from pain and CRPS-symptoms, to increase body awareness, to create vivid imagenary, to increase the use of a CRPS hand with mindfulness exposure exercises, to increase flexibility in behavioral repertoire, to explore the fusion of emotions, automatic cognitions and learned responses and to help patients to integrate new skills in their lives.', 'armGroupLabels': ['intervention']}, {'name': 'Physiotherapy intervention', 'type': 'OTHER', 'description': 'Graded motor imagenary with group and individual weekly sessions with daily practices at home.', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'HUS', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Eija Kalso, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Hanna Harno', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-04-03', 'type': 'RELEASE'}, {'date': '2021-04-28', 'type': 'RESET'}, {'date': '2023-05-30', 'type': 'RELEASE'}, {'date': '2024-02-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hanna Harno, MD, PhD, Helsinki University Central Hospital'}}}}