Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT06977932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-11', 'studyFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2025-05-11', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Visual Analog Scale (VAS) scores from baseline to the end of the 4th week of treatment', 'timeFrame': 'Baseline, 4 weeks after treatment.', 'description': 'VAS was evaluated using a standardized 10-cm horizontal scale. The scale was anchored by "0" (indicating "no pain") and "10" (indicating "unbearable pain"), with higher scores reflecting greater pain intensity. Patients self-assessed their pain level by marking the scale, and investigators quantitatively recorded the position.'}], 'secondaryOutcomes': [{'measure': 'Changes in Visual Analog Scale (VAS) scores', 'timeFrame': 'Baseline, 2 weeks after treatment, at 4-week follow-up.', 'description': 'Visual Analog Scale (VAS) scores were assessed at baseline, the end of the 2nd week of treatment, and the end of the 4th week post-treatment (follow-up), to observe changes from baseline at the 2nd week of treatment and the 4th week post-treatment respectively.'}, {'measure': 'Pain Diary Card', 'timeFrame': 'Daily from enrollment through four weeks after treatment completion', 'description': 'Daily records of carbamazepine (CBZ)/CBZ-placebo medication adherence, pain episode frequency, and adverse reactions in both groups will be maintained until the end of follow-up. The recorded data will be used for intergroup comparisons (experimental vs. control groups) and intra-group comparisons (pre-treatment vs. post-treatment) to evaluate the degree of pain status changes between groups and within individuals.'}, {'measure': 'Changes in the Patient global impression of change （PGIC）', 'timeFrame': 'Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.', 'description': "The Patient Global Impression of Change (PGIC) scale is a patient-reported outcome measure used to dynamically monitor the trajectory of health status. This scale employs a seven-point Likert scale (1=very much worse to 7=very much better) to assess the impact of therapeutic interventions on an individual's functional status. Treatment efficacy is categorized into three levels: ① disease progression (scores 0-3) indicates a worsening of symptoms; ② functional stability (score 4) suggests no significant change in symptoms; and ③ clinical improvement (scores 5-7) represents a marked reduction in symptoms. This subjective assessment tool, through longitudinal comparison with baseline data, provides a direct reflection of the patient's perceived treatment benefit."}, {'measure': 'Changes in the Brief pain inventory-facial scale （BPI-Facial）', 'timeFrame': 'Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.', 'description': 'The Brief Pain Inventory-Facial Scale (BPI-Facial) is designed to establish a three-dimensional assessment system: ① Pain intensity dimension (4 items) quantifies the frequency and severity of pain; ② Daily function dimension (7 items) assesses the impact of pain on basic life activities (including specific emotional states); ③ Facial function dimension (7 items) detects the degree of limitation in specific facial activities. Eighteen standardized items, measured from multiple perspectives, can systematically evaluate pain-related physiological, psychological, and social functional changes, providing multidimensional data support for efficacy determination.'}, {'measure': 'Changes in the Short-Form McGill Pain Questionnaire （SF-MPQ）', 'timeFrame': 'Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.', 'description': 'The Short-Form McGill Pain Questionnaire (SF-MPQ) innovatively integrates qualitative and quantitative analyses of neuropathic pain. This involves: (1) Pain quality assessment: Utilizing 11 sensory descriptors (e.g., pricking, burning) and 4 affective descriptors (e.g., annoying, fearful), a 0-3 intensity rating system is established, synthesizing a Pain Rating Index (PRI = sensory score + affective score); (2) Pain intensity assessment: Employing a Visual Analog Scale (VAS) and the Present Pain Intensity index (PPI) for supplementary quantification. This scale significantly enhances clinical applicability while maintaining assessment validity, and has become a gold standard for neuropathic pain assessment.'}, {'measure': 'Changes in the The Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS)', 'timeFrame': 'Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.', 'description': 'The Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) are widely utilized in research to differentiate between anxiety and mood disorders. After completing each scale, the raw total score (X) is obtained by summing all item scores. This raw score is then multiplied by 1.25, with the decimal portion discarded (without rounding), to derive the standardized score (Y). According to Chinese normative data, the SAS cut-off value for clinical significance is a standardized score of 50, with severity classifications as follows: 50-59 indicates mild anxiety, 60-69 moderate anxiety, and scores above 69 severe anxiety. Similarly, the SDS employs a cut-off standardized score of 53, where 53-62 corresponds to mild depression, 63-72 moderate depression, and scores exceeding 72 severe depression.'}, {'measure': 'Changes in the Short-form 36（ SF-36）', 'timeFrame': 'Baseline, 2 weeks after treatment, 4 weeks after treatment, at 4-week follow-up.', 'description': "The scale, developed by the Boston Health Institute in the United States, is characterized by multidimensional measurement properties. It systematically assesses nine core dimensions of an individual's health status: 1) physical activity; 2) role functioning; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) social functioning; 7) emotional role functioning; and 8) mental health. Furthermore, a ninth dimension is specifically designed to track changes in health status, enabling longitudinal tracking of subjects' health evolution over the past year."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electroacupuncture', 'Randomized Controlled Trial'], 'conditions': ['Trigeminal Neuralgia']}, 'descriptionModule': {'briefSummary': "Trigeminal neuralgia (TN), characterized by its refractory nature and recurrence, frequently leads to anxiety, depression, and insomnia, thereby significantly diminishing patients' quality of life and potentially inducing self-harm. Carbamazepine (CBZ) is the first-line medication for TN, yet it presents adverse effects such as addiction and the absence of analgesic effects upon cessation. Acupuncture, particularly electroacupuncture（EA）, has demonstrated efficacy in TN treatment, although its therapeutic outcomes are influenced by various factors. Consequently, this study aims to evaluate the clinical efficacy of EA for TN and its potential as an alternative to CBZ treatment.", 'detailedDescription': 'This study will enroll a total of 148 patients with TN who meet the inclusion criteria. Participants will be randomized in a 1:1 ratio to either the EA plus placebo group or the sham EA plus CBZ group. This study aims to investigate the clinical efficacy of EA for TN and to determine if EA offers a viable therapeutic alternative for TN management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must meet all of the following criteria to be eligible for this study\n\n 1. Met the diagnostic criteria for trigeminal neuralgia (TN) as defined in the International Classification of Headache Disorders, 3rd edition (ICHD-3) published by the International Headache Society (IHS) in 2018.\n 2. Between 18 and 75 years old (inclusive), regardless of gender;\n 3. Currently prescribed carbamazepine (100-300 mg/day) or oxcarbazepine (200-600 mg/day);\n 4. Conscious, alert, and capable of perceiving/differentiating pain, with basic communication abilities;\n 5. Signed informed consent form and voluntary participation in the study.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria were excluded\n\n 1. Patients with epilepsy, head injury, or other relevant neurological disorders;\n 2. Patients with severe cardiac, hepatic, or renal impairment;\n 3. Patients with cognitive dysfunction, aphasia, psychiatric disorders, or those unable to cooperate with treatment;\n 4. Patients with poorly controlled hypertension or hyperglycemia;\n 5. Patients with a recent diagnosis of severe anxiety or depression;\n 6. Pregnant or breastfeeding patients;'}, 'identificationModule': {'nctId': 'NCT06977932', 'briefTitle': 'The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'The Third Affiliated hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'The Alternative Effects of Electroacupuncture in the Treatment of Trigeminal Neuralgia: Protocol for a Multicentre Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'GZY-KJS-ZJ-2025-006-ALT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'sham EA +CBZ group', 'description': 'A cohort of 74 patients with TN will undergo treatment with CBZ in conjunction with a sham EA intervention.', 'interventionNames': ['Drug: Carbarmazepine', 'Procedure: Sham Electroacupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'EA+placebo group', 'description': 'A cohort of 74 patients diagnosed with TN will undergo treatment involving a combination of placebo and EA. The EA procedures will be administered by licensed acupuncturists who have received standardized training.', 'interventionNames': ['Drug: Carbarmazepine Placebo', 'Procedure: Electroacupuncture']}], 'interventions': [{'name': 'Carbarmazepine', 'type': 'DRUG', 'description': 'If patients were on carbamazepine (CBZ) prior to enrollment, the CBZ dose remained unchanged after enrollment; if patients were on oxcarbazepine (OXC) prior to enrollment, they received half of their pre-enrollment OXC dose as CBZ after enrollment. Orally administered for four consecutive weeks.', 'armGroupLabels': ['sham EA +CBZ group']}, {'name': 'Sham Electroacupuncture', 'type': 'PROCEDURE', 'description': 'In this group, superficial needling (0.5-1 mm depth) was performed at non-meridian points located 1 cm lateral to: (1) primary local acupoints ST2 (Sibai), ST7 (Xiaguan), and ST4 (Dicang) on the affected side; (2) branch-specific supplementary points GB1 (Tongziliao) for ophthalmic branch involvement, SI18 (Quanliao) for maxillary branch involvement, and ST6 (Jiache) for mandibular branch involvement; and (3) bilateral distal points LI4 (Hegu) and TE5 (Waiguan). Local acupoint pairs (ST7 adjacent + GB1 adjacent or ST7 adjacent +SI18 adjacent or ST7 adjacent + ST6 adjacent) and distal pairs (LI4 adjacent +TE5 adjacent) were connected to a modified electroacupuncture device with severed output wires (preventing current flow while maintaining indicator function), followed by 60-minute needle retention after parameter adjustment. Acupuncture was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.', 'armGroupLabels': ['sham EA +CBZ group']}, {'name': 'Carbarmazepine Placebo', 'type': 'DRUG', 'description': 'CBZ placebo is a tablet with identical packaging and appearance to CBZ but lacks therapeutic effects. If patients were receiving CBZ prior to enrollment, they were transitioned to a CBZ placebo at an equivalent daily dose post-enrollment. For patients previously treated with oxcarbazepine, the post-enrollment regimen consisted of a CBZ placebo administered at half the pre-enrollment oxcarbazepine dose. Orally administered for four consecutive weeks.', 'armGroupLabels': ['EA+placebo group']}, {'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'description': "The primary acupoints selected were the affected side's Sibai (ST2), Xiaguan (ST7), and Dicang (ST4). Based on the affected nerve branch, additional acupoints were chosen: for the ophthalmic branch, Tongziliao (GB1); for the maxillary branch, Quanliao (SI18); and for the mandibular branch, Jiache (ST6). Distal acupoints included bilateral Hegu (LI4) and Waiguan (SJ5). Electroacupuncture was applied based on the affected nerve branch. For the ophthalmic branch, the local acupoints selected were Xiaguan + Tongziliao; for the maxillary branch, Xiaguan + Quanliao; and for the mandibular branch, Xiaguan + Jiache. The distal acupoints selected were Hegu + Waiguan. A sparse-dense wave, 2/100Hz, was used, with a treatment duration of 60 minutes. The intensity of the electrical current was adjusted according to the patient's tolerance. Acupuncture was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.", 'armGroupLabels': ['EA+placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nisang Chen', 'role': 'CONTACT', 'email': '237247256@qq.com', 'phone': '+8615990031347'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuanyuan Wu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pingyang County Traditional Chinese Medicine Hospital', 'class': 'UNKNOWN'}, {'name': 'Jiaxing Traditional Chinese Medicine Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yuanyuan Wu', 'investigatorAffiliation': 'The Third Affiliated hospital of Zhejiang Chinese Medical University'}}}}