Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-01-26 @ 11:56 PM
Study NCT ID:
NCT02697968
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2016-02-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture for Relieving Pain in Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, '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': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-02-28', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients withdraw and the corresponding reasons', 'timeFrame': '18 weeks'}, {'measure': 'Number of subjects with and corresponding types of adverse events', 'timeFrame': '18 weeks'}, {'measure': 'Treatment Credibility by the Credibility of Treatment Rating Scale (CTRS)', 'timeFrame': 'Week 0,6 and 10'}], 'primaryOutcomes': [{'measure': 'Change in Pain Severity Numerical Rating Scale (NRS)', 'timeFrame': 'week 0 and 6'}], 'secondaryOutcomes': [{'measure': 'Types and dosage of drug(s) intake', 'timeFrame': 'week 0, 2, 4, 6, 8, 10, 12, 14 and 18'}, {'measure': 'Bath Ankylosing Spondylitis Functional Index (BASFI)', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Bath Ankylosing Spondylitis Global Index (BASGI)', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Quality of life of patients as evaluated by SF-36', 'timeFrame': 'week 0, 6, 10 and 18', 'description': 'Quality of life of patients will be measured.'}, {'measure': 'Bath Ankylosing spondylitis Metrology Index (BASMI)', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Joints count', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'timeFrame': 'week 0, 6, 10 and 18'}, {'measure': 'Change in Pain Severity Numerical Rating Scale (NRS)', 'timeFrame': 'week 0, 2, 4, 8, 10, 12, 14, and 18'}]}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Previous studies demonstrated acupuncture has significant therapeutic effects for AS in diminishing joint pain, enhancing functional disorders and modifying spinal deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence is very limited due to methodological flaws.\n\nDesign This study will be a single-arm pilot study in patients with AS. Eligible subjects will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in total) if participants request a prolonged treatment. The acupuncturist, who is a registered Chinese medicine practitioner, of this trial will not participate in data collection and data entry.\n\nObjective: To explore the treatment effect of electroacupuncture for relieving pain in ankylosing spondylitis.\n\nSetting: Hong Kong\n\nParticipants: 20 subjects with a diagnosis of ankylosing spondylitis\n\nMain Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events\n\nData analysis All data will be double-entered and checked for consistency before conducting the analysis. Binomial test will be used to analyze the percentage of responders to treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the values of all continuous variables between baseline and post treatment. The population for safety analyses will include all subjects who receive at least one acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special attention will be given to those subjects who have discontinued treatment due to adverse events or who experience serious adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. with a diagnosis of AS and fulfilled either ASAS criteria or Modified New York criteria,\n2. Bath Ankylosing Spondylitis Disease Activity Index, BASDAI ≥4,\n3. currently taking analgesic or NSAIDs for pain control,\n4. spinal pain assessment score≥4 on a numerical rating scale (NRS; 0-10 scale)\n\nExclusion Criteria:\n\n1. having active skin lesion or open wound over the needle placement areas;\n2. having heart disease, bleeding disorder or taking anticoagulant drugs\n3. have previous acupuncture experience 12 months before the baseline,\n4. are pregnant, breast-feeding or of childbearing potential but not using adequate contraception;\n5. having psoriasis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis or reactive arthritis;\n6. having unstable medical condition such as liver and/or kidney failure or cancers.;\n7. concurrently taking or injecting steroid.'}, 'identificationModule': {'nctId': 'NCT02697968', 'briefTitle': 'Electroacupuncture for Relieving Pain in Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study', 'orgStudyIdInfo': {'id': 'UW 15-458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture', 'interventionNames': ['Device: Electroacupuncture']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'DEVICE', 'armGroupLabels': ['Electroacupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Lixing LAO, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, School of Chinese Medicine', 'investigatorFullName': 'Professor LAO Lixing', 'investigatorAffiliation': 'The University of Hong Kong'}}}}