Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-27 @ 1:09 AM
Study NCT ID:
NCT01658735
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2012-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Electrotherapies for Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthew.hughes@hsc.utah.edu', 'phone': '8015814800', 'title': 'Matthew A Hughes, MD, MPH', 'organization': 'University of Utah School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Participant enrollment was based on chronic pain VAS score of \\>= 5.0 (0-10 scale). High baseline VAS scores did not translate to a priori hypothesized high ODI scores, resulting in study being underpowered to detect differences in primary outcomes.'}}, 'adverseEventsModule': {'timeFrame': 'Within 12 weeks the participant was enrolled', 'eventGroups': [{'id': 'EG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.', 'otherNumAtRisk': 39, 'otherNumAffected': 2, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.', 'otherNumAtRisk': 36, 'otherNumAffected': 2, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.', 'otherNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in Lower Extremity Tingling/Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain/Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Oswestry Disability Index at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.507', 'groupId': 'OG000', 'lowerLimit': '-4.56', 'upperLimit': '-0.45'}, {'value': '-4.725', 'groupId': 'OG001', 'lowerLimit': '-6.94', 'upperLimit': '-2.51'}, {'value': '-4.752', 'groupId': 'OG002', 'lowerLimit': '-6.94', 'upperLimit': '-2.56'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Oswestry Disability Index at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.002', 'groupId': 'OG000', 'lowerLimit': '-7.51', 'upperLimit': '-2.5'}, {'value': '-5.135', 'groupId': 'OG001', 'lowerLimit': '-7.88', 'upperLimit': '-2.39'}, {'value': '-4.581', 'groupId': 'OG002', 'lowerLimit': '-7.25', 'upperLimit': '-1.91'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Oswestry Disability Index at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.299', 'groupId': 'OG000', 'lowerLimit': '-8.19', 'upperLimit': '-2.41'}, {'value': '-5.135', 'groupId': 'OG001', 'lowerLimit': '-7.88', 'upperLimit': '-2.39'}, {'value': '-4.679', 'groupId': 'OG002', 'lowerLimit': '-7.41', 'upperLimit': '-1.89'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Oswestry Disability Index at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.388', 'groupId': 'OG000', 'lowerLimit': '-8.47', 'upperLimit': '-2.3'}, {'value': '-6.907', 'groupId': 'OG001', 'lowerLimit': '-10.32', 'upperLimit': '-3.49'}, {'value': '-5.612', 'groupId': 'OG002', 'lowerLimit': '-8.82', 'upperLimit': '-2.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VAS Pain Score at 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.458', 'groupId': 'OG000', 'lowerLimit': '-2.21', 'upperLimit': '-0.93'}, {'value': '-1.929', 'groupId': 'OG001', 'lowerLimit': '-2.75', 'upperLimit': '-1.11'}, {'value': '-2.042', 'groupId': 'OG002', 'lowerLimit': '-2.84', 'upperLimit': '-1.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VAS Pain Score at 4 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.017', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-1.13'}, {'value': '-1.691', 'groupId': 'OG001', 'lowerLimit': '-2.66', 'upperLimit': '-0.72'}, {'value': '-1.843', 'groupId': 'OG002', 'lowerLimit': '-2.79', 'upperLimit': '-0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VAS Pain Score at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.510', 'groupId': 'OG000', 'lowerLimit': '-3.53', 'upperLimit': '-1.49'}, {'value': '-2.147', 'groupId': 'OG001', 'lowerLimit': '-3.28', 'upperLimit': '-1.02'}, {'value': '-2.467', 'groupId': 'OG002', 'lowerLimit': '-3.41', 'upperLimit': '-1.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VAS Pain Score at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'OG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'OG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.624', 'groupId': 'OG000', 'lowerLimit': '-3.53', 'upperLimit': '-1.72'}, {'value': '-1.922', 'groupId': 'OG001', 'lowerLimit': '-2.91', 'upperLimit': '-0.93'}, {'value': '-2.467', 'groupId': 'OG002', 'lowerLimit': '-3.41', 'upperLimit': '-1.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'FG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'FG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care\n\nH-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.'}, {'id': 'BG001', 'title': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care\n\nTranscutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.'}, {'id': 'BG002', 'title': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.\n\nSham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '47.6', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants currently working at enrollment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants who have ever seen a Chiropractor for LBP', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants who have seen a Physician for their current LBP', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants who have been to a chronic pain clinic for their current LBP', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Participants of participants who have ever had a MRI for their current LBP', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants that have ever smoked greater than 100 cigarettes - lifetime', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of participants who have ever seen a physical therapist for LBP', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'NO', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2012-07-30', 'resultsFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-24', 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Oswestry Disability Index at 1 Week', 'timeFrame': '1 week', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.'}, {'measure': 'Change From Baseline in Oswestry Disability Index at 4 Weeks', 'timeFrame': 'Week 4', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.'}, {'measure': 'Change From Baseline in Oswestry Disability Index at 8 Weeks', 'timeFrame': 'Week 8', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.'}, {'measure': 'Change From Baseline in Oswestry Disability Index at 12 Weeks', 'timeFrame': 'Week 12', 'description': 'Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.\n\nThe ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in VAS Pain Score at 1 Week', 'timeFrame': 'Week 1', 'description': 'Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.'}, {'measure': 'Change From Baseline in VAS Pain Score at 4 Weeks', 'timeFrame': 'Week 4', 'description': 'Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.'}, {'measure': 'Change From Baseline in VAS Pain Score at 8 Weeks', 'timeFrame': 'Week 8', 'description': 'Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.'}, {'measure': 'Change From Baseline in VAS Pain Score at 12 Weeks', 'timeFrame': 'Week 12', 'description': 'Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.\n\nThe VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Higher scores represent higher reported pain.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic low back pain', 'Electrotherapy', 'H-Wave', 'H wave', 'TENS', 'Trial'], 'conditions': ['Non-specific Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '23537462', 'type': 'BACKGROUND', 'citation': 'Thiese MS, Hughes M, Biggs J. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Mar 28;14:117. doi: 10.1186/1471-2474-14-117.'}]}, 'descriptionModule': {'briefSummary': 'The intent of this project is to execute a high-quality double-blinded randomized controlled clinical trial that compares the H-Wave® device with a commonly used TENS device with a sub-therapeutic electrocurrent device. This study will provide a definable level of evidence for treatment efficacy, and provide a basis for evidence-based recommendation for or against utilization for these two modalities. The results for H-Wave® device, if positive, could significantly impact morbidity by providing a non-invasive, non-pharmacologic treatment for symptomatic relief, and reduce overall disability and health care costs associated with chronic low back pain.', 'detailedDescription': 'H-Wave® Device Stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical participants enrolled (n=38 per arm) of with the same number of visits and investigator contact time.\n\nEligible participants will be allocated through computerized randomization utilizing a stratified permuted-block randomization employing random block sizes. Allocation is concealed. Participants and assessors will be blinded. Participants will not be told what types of electrotherapy devices are being studied, only that there are different types, and that they may be randomized to receive a sham device.\n\nPatients will be instructed on the use of the device they received to perform daily home therapy. Subjects will be assessed at week 1, 4, 8 and 12 for the primary and secondary outcomes measures. Compliance to treatment will be measured through an electronic meter on each of the devices, as well as by patient diary. Patients will be allowed to receive usual care from their own health care provider, with the exception of invasive procedures or surgery. Results will be analyzed by intention to treat methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic Low Back Pain of at least 3 months duration\n* ages 18-65\n* Current VAS Pain Rating of 5 on 10 point scale\n* No pain below the knee\n* 75% of pain located in low back or buttock pain rather than lower extremity pain\n* Proficient in English\n* Able to complete and tolerate treatment for the study period.\n\nExclusion Criteria:\n\n* Prior home use of H-Wave Device or TENS.\n* Prior history of spinal fusion or failed spinal surgery syndrome.\n* Laminectomy, laminotomy or discectomy within 12 months of enrollment.\n* Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency, neuroablation within 6 months of enrollment.\n* Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, or other implanted electronic devices.\n* Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia, uncontrolled depression or anxiety disorder).\n* Patients currently or who become pregnant will be excluded.'}, 'identificationModule': {'nctId': 'NCT01658735', 'briefTitle': 'Comparison of Electrotherapies for Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Electrical Stimulation for Chronic Non-specific Low Back Pain in a Working-Age Population: A 12-Week Double Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB_00052918'}, 'secondaryIdInfos': [{'id': 'IRB_00052918'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'H-Wave Device', 'description': 'H-Wave Device with Usual Care', 'interventionNames': ['Device: H-Wave']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TENS', 'description': 'Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation (TENS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Electrotherapy', 'description': 'Sham Device plus Usual Care.', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'H-Wave', 'type': 'DEVICE', 'otherNames': ['H-Wave is the proprietary name of the device. There is only one model currently.'], 'description': 'Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.', 'armGroupLabels': ['H-Wave Device']}, {'name': 'Transcutaneous Electrical Nerve Stimulation (TENS)', 'type': 'DEVICE', 'otherNames': ['Chattanooga Intellect TENS Device'], 'description': 'Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.', 'armGroupLabels': ['TENS']}, {'name': 'Sham', 'type': 'DEVICE', 'description': 'The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.', 'armGroupLabels': ['Sham Electrotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthew A Hughes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DFPM-ADMINISTRATION'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Electronic Waveform Lab, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor (clinical)', 'investigatorFullName': 'Matt Hughes, MD, MPH', 'investigatorAffiliation': 'University of Utah'}}}}