Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-02-13 @ 4:39 PM
Study NCT ID:
NCT02487368
Status:
COMPLETED
Last Update Posted:
2015-07-02
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Mechanical Needle Stimulation Pad on Chronic 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-01', 'studyFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2015-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'day 14', 'description': 'Visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Week 14', 'description': 'Visual analogue scale'}, {'measure': 'Oswestry Low Back Pain Disability Index', 'timeFrame': 'Day 14'}, {'measure': 'Oswestry Low Back Pain Disability Index', 'timeFrame': 'Week 14'}, {'measure': 'Short Form 36 Health Survey Questionnaire (SF-36)', 'timeFrame': 'Day 14'}, {'measure': 'Short Form 36 Health Survey Questionnaire (SF-36)', 'timeFrame': 'Week 14'}, {'measure': 'Fear Avoidance Beliefs Questionnaire (FABQ)', 'timeFrame': 'Day 14'}, {'measure': 'Fear Avoidance Beliefs Questionnaire (FABQ)', 'timeFrame': 'Week 14'}, {'measure': 'Experiences with the intervention', 'timeFrame': 'Day 14', 'description': 'Open question: "please indicate observed changes"'}, {'measure': 'Medication use', 'timeFrame': 'Day 14', 'description': 'Use of medication, daily log'}, {'measure': 'Number of any adverse events', 'timeFrame': 'Day 14'}, {'measure': 'Pain intensity measured immediately after the application, visual analogue scale', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain', 'Recurrent Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The needle stimulation pad is a self-care device, which has been promoted for pain control and well-being. The aim of the study was to test the efficacy of the pad for chronic/recurrent low back pain treatment.\n\nPatients with non-specific chronic or recurrent low back pain were selected from a large health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included the Oswestry disability index (ODI), health-related quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic medication consumption and safety.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic or recurrent low back pain in the past 12 months\n* average pain intensity 4 out of 10 points\n\nExclusion Criteria:\n\n* malignant back pain\n* congenital deformities of the spine\n* dystonia or other movement disorders\n* spinal surgery within 12 months prior\n* pregnancy\n* dermatological diseases in the areas treated\n* tendency for hemorrhages\n* severe mental illness\n* recent treatment with anticoagulation, corticoid medication, acupuncture'}, 'identificationModule': {'nctId': 'NCT02487368', 'acronym': 'NRM_2009', 'briefTitle': 'Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'NRM_2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Needle stimulation pad', 'description': 'a self-administered treatment with a mechanical needle stimulation pad, a mechanical device to be used for 30 minutes daily for 14 days.', 'interventionNames': ['Device: Needle stimulation pad']}], 'interventions': [{'name': 'Needle stimulation pad', 'type': 'DEVICE', 'otherNames': ['Shakti mat, Bed of nails'], 'armGroupLabels': ['Needle stimulation pad']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gustav Dobos, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Duisburg-Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siemens-Betriebskrankenkasse', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Gustav Dobos', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}