Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-14 @ 4:53 AM
Study NCT ID:
NCT03740750
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TENS and Heat for Reducing Back Pain in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '6 different interventions will be tested in parallel on 6 equivalent groups of subjects'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-13', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of motion of the hip for flexion, extension,left and right rotation,left and right bending', 'timeFrame': 'Baseline (beginning of study before intervention)', 'description': 'range of motion in 6 degrees of freedom in the lower back'}, {'measure': 'subjective pain by marking on scale', 'timeFrame': 'Baseline (beginning of study before intervention)', 'description': 'analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst'}, {'measure': 'pressure on back that causes pain', 'timeFrame': 'Baseline (beginning of study before intervention)', 'description': 'pressure applied to lower back until pain is felt to assess inflammation'}, {'measure': 'range of motion of the hip for flexion, extension,left and right rotation,left and right bending', 'timeFrame': '4 hours after study start- at end of intervention', 'description': 'range of motion in 6 degrees of freedom in the lower back'}, {'measure': 'subjective pain by marking on scale', 'timeFrame': '4 hours after study start- at end of intervention', 'description': 'analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst'}, {'measure': 'pressure on back that causes pain', 'timeFrame': '4 hours after study start- at end of intervention', 'description': 'pressure applied to lower back until pain is felt to assess inflammation'}, {'measure': 'range of motion of the hip for flexion, extension,left and right rotation,left and right bending', 'timeFrame': '10 hours after study start( 6 hours after the modality ends)', 'description': 'range of motion in 6 degrees of freedom in the lower back'}, {'measure': 'subjective pain by marking on scale', 'timeFrame': '10 hours after study start( 6 hours after the modality ends)', 'description': 'analog visual pain scale on separate piece of paper 10cm in length- subject marks pain level with 10 the worst'}, {'measure': 'pressure on back that causes pain', 'timeFrame': '10 hours after study start( 6 hours after the modality ends)', 'description': 'pressure applied to lower back until pain is felt to assess inflammation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['heat', 'hot temperature', 'cutaneous electrostimulation'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '29381114', 'type': 'RESULT', 'citation': 'Petrofsky J, Laymon M, Khowailed I, Lee H. Synergistic Effects of Continuous Low Level Heat Wraps and Vitamins in Improving Balance and Gait in Adults. Int J Vitam Nutr Res. 2016 Jun;86(3-4):152-160. doi: 10.1024/0300-9831/a000428. Epub 2018 Jan 30.'}, {'pmid': '28282796', 'type': 'RESULT', 'citation': 'Petrofsky JS, Laymon M, Alshammari F, Khowailed IA, Lee H. Use of low level of continuous heat and Ibuprofen as an adjunct to physical therapy improves pain relief, range of motion and the compliance for home exercise in patients with nonspecific neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2017;30(4):889-896. doi: 10.3233/BMR-160577.'}, {'pmid': '25419887', 'type': 'RESULT', 'citation': 'Stark J, Petrofsky J, Berk L, Bains G, Chen S, Doyle G. Continuous low-level heatwrap therapy relieves low back pain and reduces muscle stiffness. Phys Sportsmed. 2014 Nov;42(4):39-48. doi: 10.3810/psm.2014.11.2090.'}]}, 'descriptionModule': {'briefSummary': 'Lower back pain is one of the most common and most expensive impairments costing time and expense in the work force today. With the effects on cognitive skills and addictive side effects of opioids and other prescription pain killers, there has been increasing interest in alternative medical treatments to relieve pain. Two of these that are commonly used are heat and transcutaneous electrical nerve stimulation (TENS). In the present investigation, there are two objectives 1) to determine if Tens needs to be continuous or can be intermittent and still achieve pain relief and 2) To see how long pain relief lasts after 4 hours of application of tens, heat or both. There will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. The intervention will be either TENS alone, Heat alone or Tens plus heat or a control group.', 'detailedDescription': 'There will be seventy-five subjects with chronic back pain divided into 6 groups randomly; 15 subjects per group. They are between the ages of 24 and 60 years old. They will not be taking pain medications for at least 48 hours prior to the study. The groups were as follows;\n\n1. Control\n2. heat only\n3. Tens only\n4. Tens and heat\n5. Tens for the last 15 minutes each hour plus heat\n6. Tens for the last 15 minutes each hour Tens is at threshold intensity (12 ma) at a frequency of 20 Hz either ramped continuously or for the last 15 minutes of each hour. The stimulation is 3 seconds increase to threshold, 3 seconds hold and 3 seconds ramped down followed by a 9 second rest period. Pain is assessed by an analog visual pain scale and an algometer placing pressure on the back to assess the pressure that causes pain, a measure of inflammation. In addition, the Oswestry lower back pain index and Roland Morris questionnaire are used. Range of motion in the trunk where first pain is felt is also measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. pain for at least 3 months in the lower back\n2. age range 24-60\n\nExclusion Criteria:\n\n1. Those with back pain caused by fractures or spinal damage\n2. those who had undergone low back surgery within the last year\n3. those with diagnosed diabetes\n4. no use of opiod pain meds for at least 10 days'}, 'identificationModule': {'nctId': 'NCT03740750', 'briefTitle': 'TENS and Heat for Reducing Back Pain in Humans', 'organization': {'class': 'INDUSTRY', 'fullName': 'Future Sciene Technology'}, 'officialTitle': 'The Effect of 4 Hours of Tens and Heat on Pain and Range of Motion in the Lower Back and the Duration of Pain Relief After Tens and Heat Are Removed', 'orgStudyIdInfo': {'id': 'jand m18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'sham heat and sham TENS', 'interventionNames': ['Device: sham heat', 'Device: sham Tens']}, {'type': 'EXPERIMENTAL', 'label': 'heat only', 'description': 'heat applied to the back for 4 hours with sham TENS', 'interventionNames': ['Device: Thermacare heat wraps', 'Device: sham Tens']}, {'type': 'EXPERIMENTAL', 'label': 'Tens only', 'description': 'Tens applied for 4 hours with sham heat', 'interventionNames': ['Device: TENS', 'Device: sham heat']}, {'type': 'EXPERIMENTAL', 'label': 'Heat and Tens continuous', 'description': 'Heat and Tens applied together for 4 hours', 'interventionNames': ['Device: Thermacare heat wraps', 'Device: TENS']}, {'type': 'EXPERIMENTAL', 'label': 'Tens 15', 'description': 'Tens applied only 15 minutes each hour for 4 hours, sham heat', 'interventionNames': ['Device: TENS', 'Device: sham heat']}, {'type': 'EXPERIMENTAL', 'label': 'Heat and Tens 15', 'description': 'Heat applied for 4 hours with tens only applied the last 15 minutes of each hour', 'interventionNames': ['Device: Thermacare heat wraps', 'Device: TENS']}], 'interventions': [{'name': 'Thermacare heat wraps', 'type': 'DEVICE', 'description': 'low level continuous heat wrap', 'armGroupLabels': ['Heat and Tens 15', 'Heat and Tens continuous', 'heat only']}, {'name': 'TENS', 'type': 'DEVICE', 'description': 'electrical stimulation', 'armGroupLabels': ['Heat and Tens 15', 'Heat and Tens continuous', 'Tens 15', 'Tens only']}, {'name': 'sham heat', 'type': 'DEVICE', 'description': 'expended heat wrap', 'armGroupLabels': ['Tens 15', 'Tens only', 'control']}, {'name': 'sham Tens', 'type': 'DEVICE', 'description': 'tens applied but unit not turned on', 'armGroupLabels': ['control', 'heat only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89113', 'city': 'Henderson', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'jerrold petrofsky, ph d', 'role': 'CONTACT'}], 'facility': 'Future Sciecne Technology', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}], 'centralContacts': [{'name': 'jerrold S petrofsky, Ph D', 'role': 'CONTACT', 'email': 'jpetrofsky@outlook.com', 'phone': '7143215424'}], 'overallOfficials': [{'name': 'Mike Laymon, PT, DSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Future Science Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future Sciene Technology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}