Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT05871658
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2023-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-01', 'size': 338538, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-06T00:05', 'hasProtocol': True}, {'date': '2022-03-01', 'size': 203559, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-06T00:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-20', 'studyFirstSubmitDate': '2023-04-20', 'studyFirstSubmitQcDate': '2023-05-20', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-Form of McGill Pain Questionnaire(SF - MPQ)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Short-Form of McGill Pain Questionnaire(SF - MPQ)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Expanded Disability Status Scale(EDSS)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Expanded Disability Status Scale(EDSS)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'numerical rating scale(NRS)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'numerical rating scale(NRS)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Self-Rating Anxiety Scale (SAS)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Self-Rating Anxiety Scale (SAS)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Self-rating Depression Scale (SDS)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Self-rating Depression Scale (SDS)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}, {'measure': '36-item Short-Form (SF-36)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a better outcome.'}, {'measure': '36-item Short-Form (SF-36)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a better outcome.'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'tumor necrosis factor-α （TNF-α）', 'timeFrame': 'on the baseline', 'description': 'higher scores mean a worse outcome.'}, {'measure': 'tumor necrosis factor-α （TNF-α）', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromyelitis Optica Spectrum Disorders', 'Pain']}, 'descriptionModule': {'briefSummary': 'Abstract Background Neuropathic pain is a common complication in neuromyelitis optica spectrum disorder (NMOSD), which seriously affects the quality of life of NMOSD patients, with no satisfactory treatment. Through the previous literature study and clinical observation, we found that acupuncture has good curative effect in the treatment of pain, especially electric acupuncture, but thestudies on acupuncture intervention in pain of NMOSD are still scare.\n\nObjective To evaluate the clinical efficacy of electroacupuncture on NMOSD patients with pain.\n\nMaterials and Methods In this exploratory randomized controlled study, NMOSD patients with pain were recruited from March 21, 2022 to February 21, 2023. Patients meeting the inclusion and exclusion criteria were randomly assigned to the electroacupuncture group (experimental group) and the sham electroacupuncture group (control group) by simple random method (envelope method) according to the inclusion order. Totally, there are 20 patients enrolled.\n\nThe experimental group received electroacupuncture therapy and the control group received sham electroacupuncture therapy. A total of 8 sessions were given twice a week for 30 minutes each. On the baseline, demographic information, medication history, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected, the brain, cervical and thoracic MRI were perfected and collected, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SDS, EDSS. After the treatment, specimens of routine blood, blood biochemistry, liver function, IL - 6, TNF-α were collected again, patients filled in the SF - MPQ, NRS, SF - 36, SAS, SD, EDSS. The main outcome indicators were SF-MPQ, and the secondary outcome indicators were EDSS, NRS, SAS, SDS, SF-36, IL-6, and TNF-α.\n\nConclusion This is the first exploratory randomized controlled study to evaluate the efficacy of electroacupuncture on pain in patients with NMOSD. The study will provide clincial evidence of the practice of electroacupuncture on NMOSD with pain.\n\nKey Words neuromyelitis optica spectrum disorders; pain; electroacupuncture'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. people diagnosed as NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria.\\[21\\]\n2. NRS≥4.\n3. people were treated with stable doses of biological therapy and/or prednisone, with no regimen adjustment within 30 days prior to enrollment.\n4. people did not adjust any standard pain medication combinations, including antiepileptic drugs, antidepressants, and opioids, within 30 days before enrollment.\n5. people or their families provided written informed consent.\n\nExclusion Criteria:\n\n1. people enrolled in other clinical studies.\n2. people with low cognitive or mental ability.\n3. people who became pregnant during the study period, breastfed, or planned to become pregnant.\n4. people with serious diseases related to the heart, liver, kidney or hematopoietic system.\n5. people with diabetic peripheral neuropathy.'}, 'identificationModule': {'nctId': 'NCT05871658', 'briefTitle': 'Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}, 'officialTitle': 'Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol', 'orgStudyIdInfo': {'id': '20230221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the electroacupuncture group', 'description': 'electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient.', 'interventionNames': ['Behavioral: electroacupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'the sham electroacupuncture group', 'description': 'According to the previous trial,\\[19\\] sham acupoints were 1cm away from the level of the acupoints used in the EA group, which avoided the area corresponding to any of the 14 meridians of TCM. The insertion of the needle was shallower (less than 0.2cm) and had similar pain to that of normal needle insertion. The stimulation intensity was 0mA. However, the model of electroacupuncture, the frequency, and duration of treatment in the SEA group were identical in the TA group.', 'interventionNames': ['Behavioral: electroacupuncture']}], 'interventions': [{'name': 'electroacupuncture', 'type': 'BEHAVIORAL', 'description': 'electroacupuncture were inserted into bilateral Zusanli (ST36), Sanyinjiao (SP6), Hegu (LI4) and Quchi (LI11), and Yintang (EX-HN3). Electroacupuncture parameters selected the sparse wave, the frequency was 4 Hz, the stimulation intensity was tolerated by the patient.', 'armGroupLabels': ['the electroacupuncture group', 'the sham electroacupuncture group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Hospital of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zhao yuan qi, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuanqi Zhao,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Yuanqi Zhao,MD', 'investigatorAffiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}}}}