Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-01 @ 7:25 PM
Study NCT ID:
NCT06190366
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and treatment adherence', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence.'}, {'measure': 'Treatment adherence', 'timeFrame': '3 weeks', 'description': 'Assess treatment adherence according to attendance during 3 week intervention period.'}, {'measure': 'Treatment expectation: effectiveness of bloodletting acupuncture in reducing low back pain', 'timeFrame': 'Baseline', 'description': 'Assess treatment expectation at baseline, Likert scale (1-very good effectiveness to 5-poor effectiveness)'}], 'primaryOutcomes': [{'measure': 'Change from baseline in average pain intensity in previous week', 'timeFrame': 'Baseline, 3 weeks', 'description': 'Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in average pain intensity in previous week', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).'}, {'measure': 'Change from baseline in average pain intensity of the last 24 hours', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).'}, {'measure': 'Change from baseline for back pain specific disability', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Use of standardized Roland Morris Disability Questionnaire (RMDQ) to assess back pain specific disability. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.'}, {'measure': 'Change from baseline in pain bothersomeness in previous week', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100).'}, {'measure': 'Change from baseline for days with pain medication use', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Specific self-reported pain medication use'}, {'measure': 'Change from baseline for health related quality of life', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Use of standardized Short Form 36 Health Survey (SF-36). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.'}, {'measure': 'Change from baseline for pain self-efficacy', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Use of standardized Pain Self-Efficacy Questionnaire (PSEQ). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.'}, {'measure': 'Change from baseline for anxiety and depression', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Use of standardized Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.'}, {'measure': 'Change from baseline for work productivity', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Use standardized Work Productivity and Activity Impairment Questionnaire (WPAI) to assess employment status and productivity. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Back Pain, Low']}, 'descriptionModule': {'briefSummary': 'Evaluation of a bloodletting acupuncture at the fossa poplitea in comparison to bloodletting acupuncture at the regio glutaea and a waiting list control group in patients with subacute and chronic non-specific pain low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Specialist confirmed diagnosis of subacute or chronic non-specific low back pain for at least 6 weeks prior to inclusion\n* Average pain intensity with at least 50 mm on the VAS from 0 to 100 mm\n\nExclusion criteria:\n\n* Serious illnesses\n* Poor general condition\n* Coagulation disorder, therapy with anticoagulants\n* Thrombophlebitis, skin inflammation in the area of the lower extremities\n* Alcohol, drug or medication addiction\n* Pregnancy\n* Lack of willingness to cooperate, linguistically or mentally unable to understand the contents of the study\n* Participation in another clinical trial during the study period\n* Starting a new therapy for the treatment of low back pain in the last 2 weeks'}, 'identificationModule': {'nctId': 'NCT06190366', 'briefTitle': 'Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Mikroaderlass'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bloodletting acupuncture at the fossa poplitea', 'interventionNames': ['Procedure: Bloodletting acupuncture at the fossa poplitea']}, {'type': 'EXPERIMENTAL', 'label': 'Bloodletting acupuncture at the regio glutaea', 'interventionNames': ['Procedure: Bloodletting acupuncture at the regio glutaea']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting list control group'}], 'interventions': [{'name': 'Bloodletting acupuncture at the fossa poplitea', 'type': 'PROCEDURE', 'description': 'This group is treated with bloodletting acupuncture at the fossa poplitea. The treatment takes place twice a week from week 1 to week 3. This means that 6 treatments of approx. 20 minutes each should be carried out within the 3 weeks.', 'armGroupLabels': ['Bloodletting acupuncture at the fossa poplitea']}, {'name': 'Bloodletting acupuncture at the regio glutaea', 'type': 'PROCEDURE', 'description': 'This group is treated with bloodletting acupuncture at the regio glutaea. The treatment takes place twice a week from week 1 to week 3. This means that 6 treatments of approx. 20 minutes each should be carried out within the 3 weeks.', 'armGroupLabels': ['Bloodletting acupuncture at the regio glutaea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14163', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Miriam Rösner, Study Nurse', 'role': 'CONTACT', 'email': 'naturheilkunde.studien@immanuel.de', 'phone': '+49 (0)30 - 80505 - 682'}], 'facility': 'Charité Hochschulambulanz für Naturheilkunde, Immanuel Krankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Miriam Rösner', 'role': 'CONTACT', 'email': 'naturheilkunde.studien@immanuel.de', 'phone': '+49 30 80505 682'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}