Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT00932360
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2009-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': 'dana-dailey@uiowa.edu', 'phone': '319-335-7149', 'title': 'Dana Dailey', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '43 subjects were enrolled to the study and completed a treatment (Active TENS, Placebo TENS or No TENS) in a randomized order with a one week washout period between treatments. Results were analyzed by comparing the groups for outcome measures.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain at Rest Difference Score Pre-intervention and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': 'Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '-0.47', 'spread': '0.26', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain With Movement Difference Score Pre-intervention and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS to No Treatment to Placebo (ANP)', 'description': 'Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.'}, {'id': 'OG001', 'title': 'Active TENS to Placebo to No Treatment (APN)', 'description': 'Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.'}, {'id': 'OG002', 'title': 'No Treatment to Active TENS to Placebo TENS (NAP)', 'description': 'Active and Placebo TENS with configured Rehabilicare Unit; No TENS with TENS worn and not turned on.r'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.26', 'spread': '0.25', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatigue at Rest Difference Score Pre-intervention and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fatigue With Movement Difference Score Pre-intervention and Post Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PPT Cervical Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'classes': [{'categories': [{'measurements': [{'value': '53.15', 'spread': '10.09', 'groupId': 'OG000'}, {'value': '26.42', 'spread': '10.02', 'groupId': 'OG001'}, {'value': '19.39', 'spread': '10.06', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Pressure pain threshold cervical region (kPa)', 'unitOfMeasure': 'pressure score (kPa)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PPT Lumbar Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'classes': [{'categories': [{'measurements': [{'value': '86.97', 'spread': '15.97', 'groupId': 'OG000'}, {'value': '34.89', 'spread': '15.91', 'groupId': 'OG001'}, {'value': '33.23', 'spread': '15.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Pressure pain threshold in lumbar region (kPa)', 'unitOfMeasure': 'pressure score (kPa)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PPT for Anterior Tibialis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'classes': [{'categories': [{'measurements': [{'value': '62.86', 'spread': '18.34', 'groupId': 'OG000'}, {'value': '38.98', 'spread': '21.85', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '15.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Pressure pain threshold in leg (kPa)', 'unitOfMeasure': 'pressure score (kPa)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '6 Minute Walk Test Average Change (Feet)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active TENS', 'description': '100 Hz, 200 μs at maximal tolerable intensity'}, {'id': 'OG001', 'title': 'Placebo TENS', 'description': 'TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame'}, {'id': 'OG002', 'title': 'No TENS', 'description': 'Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'classes': [{'categories': [{'measurements': [{'value': '41.85', 'spread': '36.7', 'groupId': 'OG000'}, {'value': '-40.48', 'spread': '36.31', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '36.01', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': '6 minute walk test average change (feet) before and after intervention', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active TENS, Placebo TENS and No TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}, {'id': 'FG001', 'title': 'Active TENS No TENS Placebo TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}, {'id': 'FG002', 'title': 'Placebo TENS Active TENS No TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}, {'id': 'FG003', 'title': 'Placebo TENS No TENS Active TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}, {'id': 'FG004', 'title': 'No TENS Active TENS Placebo TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}, {'id': 'FG005', 'title': 'No TENS Placebo TENS Active TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS:TENS at 100 Hz, 200 μs for 30 seconds and then the current ramped off over a 15 second time frame No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor'}], 'periods': [{'title': '1: Visit 1/Week1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Visit 2/Week 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout (One Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Visit 3/Week 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects (125) were screened for eligibility via telephone. 82 were excluded and 43 were consented and enrolled at the University of Iowa', 'preAssignmentDetails': '43 subjects were consented and enrolled to the cross over design study. Subjects were randomized to treatment group order after providing written consent. The three treatment groups for randomization order included: active TENS, placebo TENS and no treatment TENS.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This is a crossover study with three groups. Subjects completed each arm of the study in random order.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '2 subjects withdrew from the study after the first visit'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '2 subjects withdrew after 1 visit'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2009-06-23', 'resultsFirstSubmitDate': '2017-03-28', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-09', 'studyFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain at Rest Difference Score Pre-intervention and Post Intervention', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.'}, {'measure': 'Pain With Movement Difference Score Pre-intervention and Post Intervention', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.'}], 'secondaryOutcomes': [{'measure': 'Fatigue at Rest Difference Score Pre-intervention and Post Intervention', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.'}, {'measure': 'Fatigue With Movement Difference Score Pre-intervention and Post Intervention', 'timeFrame': '3 weeks', 'description': 'Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.'}, {'measure': 'PPT Cervical Region', 'timeFrame': '3 weeks', 'description': 'Pressure pain threshold cervical region (kPa)'}, {'measure': 'PPT Lumbar Region', 'timeFrame': '3 weeks', 'description': 'Pressure pain threshold in lumbar region (kPa)'}, {'measure': 'PPT for Anterior Tibialis', 'timeFrame': '3 weeks', 'description': 'Pressure pain threshold in leg (kPa)'}, {'measure': '6 Minute Walk Test Average Change (Feet)', 'timeFrame': '3 weeks', 'description': '6 minute walk test average change (feet) before and after intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fibromyalgia', 'Transcutaneous Electrical Nerve Stimulation (TENS)'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '23900134', 'type': 'RESULT', 'citation': 'Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.'}], 'seeAlsoLinks': [{'url': 'https://www-ncbi-nlm-nih-gov.proxy.lib.uiowa.edu/pmc/articles/PMC3972497/', 'label': 'PubMed Link for full text article'}]}, 'descriptionModule': {'briefSummary': "Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue and tenderness with hyperalgesia to pressure over tender points. Pain associated with fibromyalgia can interfere with daily function, work, and social activities. Thus, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Although the etiology of fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced central inhibition, and enhanced temporal summation. Reducing pain in people with fibromyalgia would help increase the patient's ability to return to work, perform activities of daily living and thus improve the quality of life for the patient. Transcutaneous electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers electrical stimulation through the skin and is used for both acute and chronic pain. TENS works by reducing central excitability and increasing central inhibition. Thus, the investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that this decrease in pain and/or central excitability will improve function. The primary aim of the study is to test the effectiveness of TENS on pain and central excitability in a crossover design study for patients with Fibromyalgia with random assignment to three treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary aim is to test the effect of decreased pain and central excitability on function in patients with Fibromyalgia.", 'detailedDescription': 'The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Subjects will draw the order for treatments (A, B, and C) out of a bowl at the initial testing session. This will determine the order of the testing. Each subject will receive all 3 treatments in random order.\n\nThe following tools will be used to measure subject characteristics (Fibromyalgia Impact Questionnaire, Tampa Scale of Kinesiophobia), pain (McGill Pain Questionnaire and Visual Analogue Scale), central excitability (pressure pain thresholds, temporal summation and DNIC) and function (6 minute walk test, range of motion, sit to stand test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fibromyalgia diagnosis by a physician\n* History of cervical or lumbar pain\n\nExclusion Criteria:\n\n* TENS use in the last 5 years\n* Pacemaker\n* No use of opioids'}, 'identificationModule': {'nctId': 'NCT00932360', 'acronym': 'TENS&FM', 'briefTitle': 'Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)', 'nctIdAliases': ['NCT00750321'], 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Transcutaneous Electrical Nerve Stimulation (TENS) and Fibromyalgia (FM)', 'orgStudyIdInfo': {'id': '200903744'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active TENS Placebo TENS No TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor', 'interventionNames': ['Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo TENS Active TENS No TENS', 'description': 'Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Participants wore a TENS unit that was turned off for blinding of the outcome assessor', 'interventionNames': ['Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'No TENS Active TENS Placebo TENS', 'description': 'No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off', 'interventionNames': ['Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Active TENS No TENS Placebo TENS', 'description': 'Active TENS: 100 Hz, 200 μs at maximal tolerable intensity No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off', 'interventionNames': ['Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo TENS No TENS Active TENS', 'description': 'Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Participants wore a TENS unit that was turned off for blinding of the outcome assessor Active TENS: 100 Hz, 200 μs at maximal tolerable intensity', 'interventionNames': ['Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'No TENS Placebo TENS Active TENS', 'description': 'No TENS: Participants wore a TENS unit that was turned off for blinding of the outcome assessor Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramped off Active TENS: 100 Hz, 200 μs at maximal tolerable intensity', 'interventionNames': ['Device: TENS']}], 'interventions': [{'name': 'TENS', 'type': 'DEVICE', 'otherNames': ['Rehabilicare Maxima'], 'description': 'Active TENS, Placebo TENS and No Treatment TENS', 'armGroupLabels': ['Active TENS No TENS Placebo TENS', 'Active TENS Placebo TENS No TENS', 'No TENS Active TENS Placebo TENS', 'No TENS Placebo TENS Active TENS', 'Placebo TENS Active TENS No TENS', 'Placebo TENS No TENS Active TENS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa - Physical Therapy and Rehabilitation Science', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Dana L Dailey, PT,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Kathleen A Sluka, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Iowa'}, {'name': 'Barbara Rakel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'See Publication listed for data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana Dailey', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Physical Therapy Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Dana Dailey', 'investigatorAffiliation': 'University of Iowa'}}}}