Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT06344403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D000700', 'term': 'Analgesics'}], 'ancestors': [{'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-03-27', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of postherpetic neuralgia using VAS score', 'timeFrame': '12 months', 'description': '12 months after the treatments, number of patients with any pain with a VAS score of higher than 0/Number of all patients，0="no pain" and 10="worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'visual analogue scale score at each time point', 'timeFrame': 'before the treatment (baseline), 30min after the intervention (for TPI group), then 1 day, 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment', 'description': "0 = 'no pain at all' to 10 = 'worst pain imaginable'"}, {'measure': 'Proportion of patients receiving repeated TPIs and block points', 'timeFrame': '12 months', 'description': 'Number of patients receiving TPI treatments more than twice/Number of all patients'}, {'measure': 'Consumption of oral drugs at each time point', 'timeFrame': 'day 1, then 2 weeks, 1 month, 3 months, 6 months and 12 months following the treatment.', 'description': 'Dose of celecoxib, pregabalin and tramadol'}, {'measure': 'The presence of PHN at month 3 and month 6 post treatment', 'timeFrame': '3 and 6 months after treatments', 'description': "Number of patients with any pain with a VAS score of higher than 0/Number of all patients (0 = 'no pain at all' to 10 = 'worst pain imaginable')"}, {'measure': 'Patient satisfaction scores on the 5-point Likert scale', 'timeFrame': 'day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment', 'description': '1: Very dissatisfied,2: Dissatisfied,3: Not sure,4: Satisfied,5: Very satisfied'}, {'measure': 'Quality of life on the Scores on the WHOQOL-BREF', 'timeFrame': 'day 1, then week 2, month 1, month 3, month 6 and month 12 following the treatment', 'description': 'Scores on the WHOQOL-BREF. The responses are given on 5-point Likert scale (1-5) and the overall score ranges from 0 to 100; a higher score corresponds to better QoL.'}, {'measure': 'Adverse reactions through study completion', 'timeFrame': 'After treatments', 'description': 'Any side effect and uncomfortable situation related to treatment through study completion，an average of 1 year'}, {'measure': 'Predictive factors for the prevention of PHN at month 12 posttreatment', 'timeFrame': 'month 12 posttreatment', 'description': "the correlation between patients' baseline characteristics and the incidence of PHN will be analyzed 12 months after treatment in TPI group."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Herpes zoster', 'Acute pain'], 'conditions': ['Herpes Zoster', 'Local Infiltration', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only.', 'detailedDescription': 'The conventional therapies for HZ infection can be seen in two phases. Those in acute phase are mainly antiviral (acyclovir, famciclovir, etc.), analgesic drugs (opioids, acetaminophen or nonsteroidal anti-inflammatory agents, gabapentin, etc.), while these conventional drug therapies could yield potential side effects, and part of patients are not fully satisfied with the analgesic effect. It is considered that supplementary and alternative local therapies may have better results with less side effects and reduce medical costs to relieve pain associated with HZ infection. These options, including nerve blockade (epidural injection, paravertebral injection, sympathetic block, intercostal nerve block, intracutaneous injection), pulsed radiofrequency16, acupuncture, fire needling acupuncture, electrical nerve stimulation19, lidocaine patch, capsaicin cream, and botulinum toxin injection have been reported to give positive therapeutic effects on acute herpes zoster neuralgia (AHN), however, evidence for the efficacy of existing local therapies is limited and risks may occur due to high invasiveness of some procedures, there is insufficient evidence and expert agreement to make recommendations for these intervention strategies as first-line treatments in guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with onset of HZ rash less than 90 days.\n2. HZ affected the spinal nerves (cervical/thoracic/lumbar nerve).\n3. Aged 18 to 75 years (inclusive).\n4. Pain intensity \\> 7 cm on a visual analogue scale (VAS 0-10 cm).\n5. Agreed to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Infection at the puncture site.\n2. Poor general situation unable to be treated.\n3. A history of abuse of narcotics.\n4. Non-compliance or inability to complete the self-evaluation questionnaires.\n5. Pregnancy or lactation.\n6. Patients using immunosuppressants and those with severe systemic diseases such as hematological malignancies, cancers, or autoimmune disorders.'}, 'identificationModule': {'nctId': 'NCT06344403', 'briefTitle': 'Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Management of Acute and Subacute Zoster Associated Pain', 'orgStudyIdInfo': {'id': 'KY2024-045-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard gorup', 'description': 'Patients will receive standard oral medicine for herpes zoster.', 'interventionNames': ['Drug: analgesic']}, {'type': 'EXPERIMENTAL', 'label': 'TPI group', 'description': 'Patients will receive standard medicine treatment and tender point infiltrations therapy.', 'interventionNames': ['Drug: analgesic', 'Behavioral: Tender point infiltration']}], 'interventions': [{'name': 'analgesic', 'type': 'DRUG', 'otherNames': ['Standard treatment'], 'description': 'Patients will receive daily 300 mg pregabalin in divided doses (150 mg/12 hours). Once the patient report mild pain (VAS ≤ 3), the trial for reducing the pregabalin dose will be done. Nonsteroidal anti-inflammatory drug celecoxib (200 mg on request, up to two times daily)27 and tramadol (100 mg on request, up to 400mg daily) will be available for as-needed analgesia.', 'armGroupLabels': ['Standard gorup', 'TPI group']}, {'name': 'Tender point infiltration', 'type': 'BEHAVIORAL', 'otherNames': ['TPI infiltration'], 'description': 'Lidocaine mixed with diprospan injected into tender points.', 'armGroupLabels': ['TPI group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Fang Luo, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Pain Managrment', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}