Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 7:08 PM
Study NCT ID:
NCT02047851
Status:
TERMINATED
Last Update Posted:
2019-10-16
First Post:
2014-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D018771', 'term': 'Arthralgia'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Not enough study participants, difficulties in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-14', 'studyFirstSubmitDate': '2014-01-26', 'studyFirstSubmitQcDate': '2014-01-26', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measured on the VAS', 'timeFrame': 'From day 0 to day 60 of the trial', 'description': 'Patients will record their level of pain in a journal each day, ranging from 0 to 10 where 0 is no pain and 10 is worst possible pain.'}, {'measure': 'Improvement in life quality measured with the DLQI (Dermatology Life Quality Index)', 'timeFrame': 'From day 0 to day 60 of the study period', 'description': 'On day 0, 30 and 60 the patients will fill out a simple questionnaire with 10 questions concerning their life quality'}], 'secondaryOutcomes': [{'measure': 'Approvement in skin lesions', 'timeFrame': 'From day 0 to day 60 of the study period', 'description': 'At each of the 3 control visits the patients will be asked if their psoriatic skin lesions have become better from the acupuncture, and if they say yes, how much better? Minimal improvement, moderate improvement og big improvement?'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Psoriasis', 'Arthralgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether acupuncture is helpful for patients with joint pain associated with psoriasis', 'detailedDescription': 'In this study, patients with psoriasis and joint pain will receive either real acupuncture or sham acupuncture to see if acupuncture can be an effective treatment of joint pain in patients with psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Plaque psoriasis\n* Pain from at least two peripheral joints and/or inflammatory back pain\n* No or stabile treatment of the psoriasis the last 3 months\n* No or stabile pain treatment the last 3 months\n* Oral and written information given\n* Written consent signed\n\nExclusion Criteria:\n\n* Arthritis with Ultrasound verified intra articular fluid og clinical verified joint swelling\n* Pregnancy og breastfeeding\n* Previous treatments with acupuncture\n* Treatment with anticoagulants (vitamin K-antagonists, low molecular weight heparin, unfractionated heparin, direct thrombin inhibitors, direct factor Xa inhibitors)\n* Unwilling to follow protocol'}, 'identificationModule': {'nctId': 'NCT02047851', 'briefTitle': 'Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Randomized, Blinded, Sham-controlled Trial of Acupuncture for the Management of Joint Pain in Patients With Psoriasis', 'orgStudyIdInfo': {'id': 'H-1-2013-122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acupuncture in active points', 'description': 'Patients in this group will receive real acupuncture', 'interventionNames': ['Other: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Acupuncture in non-active points', 'description': 'Patients in this group will receive acupuncture, but in non-active points', 'interventionNames': ['Other: Acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment, just observation', 'description': 'Patients in this group will receive no treatment and will only be observed.'}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group', 'armGroupLabels': ['Acupuncture in active points', 'Acupuncture in non-active points']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Gentofte University hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'The departement of allergy and dermatology, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aage Bangs Fond', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Annesofie Faurschou', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}