Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04227067
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2020-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TENS for Back Pain Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-03', 'mcpReleaseN': 5, 'releaseDate': '2024-11-08'}], 'estimatedResultsFirstSubmitDate': '2024-11-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'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': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2020-01-10', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severity', 'timeFrame': '30 minutes after application of TENS unit', 'description': 'Pain severity graded on a verbal numeric pain scales from none (0) to most (10)'}], 'secondaryOutcomes': [{'measure': 'Use of rescue medications', 'timeFrame': '30 minutes after application of the TENS unit', 'description': 'The percentage of patients that were administered an additional analgesic medication after the application of TENS'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['TENS, back pain, ibuprofen'], 'conditions': ['Back Pain']}, 'referencesModule': {'references': [{'pmid': '40202296', 'type': 'DERIVED', 'citation': 'Otterness K, McMahon B, Ma M, Thode HC Jr, Singer AJ. The use of TENS for the treatment of back pain in the emergency department: A randomized controlled trial. Acad Emerg Med. 2025 Aug;32(8):828-835. doi: 10.1111/acem.70013. Epub 2025 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'In this study we will see if application of TENS for a period of 30 minutes in addition to ibuprofen reduces the pain of emergency department patients with back pain compared with ibuprofen and a sham TENS unit.', 'detailedDescription': 'Adult patients presenting to the emergency department with moderate to severe back pain of relatively short duration without neurological deficits will be eligible for inclusion in the study. After signing informed consent the patients will rate their pain severity and receive a 400 mg dose of ibuprofen and then randomly be assigned to either TENS or sham TENS for 30 minutes. At the end of the study period patients will again be asked to rate their pain severity and indicate whether their pain got better or worse. We will also ask them to try and guess which treatment they received and whether they require any medications for their pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 18 years or greater\n* Able to consent\n* Back pain of less than 2 weeks duration\n* Pain severity of at least 5/10 on a verbal numeric scale from 0 (none) to 10 (worst)\n\nExclusion Criteria:\n\n* Pregnant patients\n* Minors\n* Prisoners\n* Neurological deficits'}, 'identificationModule': {'nctId': 'NCT04227067', 'briefTitle': 'TENS for Back Pain Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'The Use of TENS for the Treatment of Back Pain in the Emergency Department', 'orgStudyIdInfo': {'id': 'IRB2019-00435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TENS', 'description': 'A TENS device consists of an electric pulse generator and pads that are attached to the skin on around the area of maximal pain. We will use the conventional mode, which provides nerve stimulation with a pulse width of 60 microseconds and a pulse rate of 60 pulses per second. The channel intensity will be gradually increased until the intensity is noticeable but not painful.', 'interventionNames': ['Device: TENS']}, {'type': 'SHAM_COMPARATOR', 'label': 'SHAM TENS', 'description': 'In the SHAM TENS group the TENS pads will be attached to the pulse generator and the patients skin around the painful area. The investigator will turn the knobs on but the batteries will be removed from the device.', 'interventionNames': ['Device: SHAM TENS']}], 'interventions': [{'name': 'TENS', 'type': 'DEVICE', 'description': 'An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.', 'armGroupLabels': ['TENS']}, {'name': 'SHAM TENS', 'type': 'DEVICE', 'description': 'A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.', 'armGroupLabels': ['SHAM TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'Adam Singer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stony Brook University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Vice Chairman for Research', 'investigatorFullName': 'Adam Singer', 'investigatorAffiliation': 'Stony Brook University'}}}}