Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-02-17 @ 3:24 PM
Study NCT ID:
NCT00125268
Status:
TERMINATED
Last Update Posted:
2012-09-05
First Post:
2005-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Near Infrared Light for the Treatment of Painful Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'butters.matthew@mayo.edu', 'phone': '480-301-7745', 'title': 'Dr. Matthew A. Butters', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was terminated early because the study was unable to enroll enough patients.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the 4 weeks of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.'}], 'timeFrame': 'baseline, 4 weeks', 'description': 'Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.'}], 'timeFrame': 'baseline, 4 weeks', 'description': 'The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.'}], 'timeFrame': 'baseline, 4 weeks', 'description': 'The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).'}, {'id': 'FG001', 'title': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).'}, {'id': 'BG001', 'title': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '17', 'groupId': 'BG000'}, {'value': '74', 'spread': '11', 'groupId': 'BG001'}, {'value': '71', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Unable to enroll enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2005-07-27', 'resultsFirstSubmitDate': '2012-08-02', 'studyFirstSubmitQcDate': '2005-07-28', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-02', 'studyFirstPostDateStruct': {'date': '2005-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects That Have a Greater Than or Equal to Forty Percent Decrease on the Visual Analog Pain Scale at the End of Four Weeks of Treatment', 'timeFrame': 'baseline, 4 weeks', 'description': 'Pain was measured by a 10 cm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. On this scale 0 means no pain and 10 cm means extreme pain. The investigator measures the mark made by the subject in cm and records this for the value of pain.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects That Have a Forty Percent Reduction of Pain Measured by the Neuropathic Pain Scale at the End of Four Weeks of Treatment', 'timeFrame': 'baseline, 4 weeks', 'description': 'The neuropathic pain scale consists of 10 questions with individual answers rated from 1 to 10, with 0 = no pain to 10 = the most intense pain imaginable. The overall score could range from 0 to 100, with 0 = no pain to 100 = the most intense pain imaginable.'}, {'measure': 'Percentage of Subjects That Have an Improvement of Two Points or More on the SF-8 at the End of Four Weeks of Treatment', 'timeFrame': 'baseline, 4 weeks', 'description': 'The SF-8 Health Survey has 8 questions, each question measuring each of the eight domains of health. Scores are calibrated so that 50 is the average score or norm. A lower score indicates poorer health, and a higher score indicates excellent health.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['painful', 'peripheral', 'neuropathy', 'light', 'therapy'], 'conditions': ['Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '9040716', 'type': 'BACKGROUND', 'citation': 'Galer BS, Jensen MP. Development and preliminary validation of a pain measure specific to neuropathic pain: the Neuropathic Pain Scale. Neurology. 1997 Feb;48(2):332-8. doi: 10.1212/wnl.48.2.332.'}, {'pmid': '9846777', 'type': 'BACKGROUND', 'citation': 'Backonja M, Beydoun A, Edwards KR, Schwartz SL, Fonseca V, Hes M, LaMoreaux L, Garofalo E. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA. 1998 Dec 2;280(21):1831-6. doi: 10.1001/jama.280.21.1831.'}, {'pmid': '2046920', 'type': 'BACKGROUND', 'citation': "Dyck PJ, Kratz KM, Lehman KA, Karnes JL, Melton LJ 3rd, O'Brien PC, Litchy WJ, Windebank AJ, Smith BE, Low PA, et al. The Rochester Diabetic Neuropathy Study: design, criteria for types of neuropathy, selection bias, and reproducibility of neuropathic tests. Neurology. 1991 Jun;41(6):799-807. doi: 10.1212/wnl.41.6.799."}, {'pmid': '19078638', 'type': 'BACKGROUND', 'citation': 'Holland NR. Idiopathic painful sensory neuropathy. J Clin Neuromuscul Dis. 2001 Jun;2(4):211-20. doi: 10.1097/00131402-200106000-00008.'}, {'pmid': '11904323', 'type': 'BACKGROUND', 'citation': 'Kochman AB, Carnegie DH, Burke TJ. Symptomatic reversal of peripheral neuropathy in patients with diabetes. J Am Podiatr Med Assoc. 2002 Mar;92(3):125-30. doi: 10.7547/87507315-92-3-125.'}, {'pmid': '14693984', 'type': 'BACKGROUND', 'citation': 'Leonard DR, Farooqi MH, Myers S. Restoration of sensation, reduced pain, and improved balance in subjects with diabetic peripheral neuropathy: a double-blind, randomized, placebo-controlled study with monochromatic near-infrared treatment. Diabetes Care. 2004 Jan;27(1):168-72. doi: 10.2337/diacare.27.1.168.'}, {'pmid': '12660389', 'type': 'BACKGROUND', 'citation': 'Mendell JR, Sahenk Z. Clinical practice. Painful sensory neuropathy. N Engl J Med. 2003 Mar 27;348(13):1243-55. doi: 10.1056/NEJMcp022282. No abstract available.'}, {'pmid': '15251618', 'type': 'BACKGROUND', 'citation': 'Prendergast JJ, Miranda G, Sanchez M. Improvement of sensory impairment in patients with peripheral neuropathy. Endocr Pract. 2004 Jan-Feb;10(1):24-30. doi: 10.4158/EP.10.1.24.'}, {'pmid': '9848001', 'type': 'BACKGROUND', 'citation': 'Koltzenburg M. Painful neuropathies. Curr Opin Neurol. 1998 Oct;11(5):515-21. doi: 10.1097/00019052-199810000-00014.'}, {'pmid': '15221874', 'type': 'BACKGROUND', 'citation': 'Wolfe GI, Trivedi JR. Painful peripheral neuropathy and its nonsurgical treatment. Muscle Nerve. 2004 Jul;30(1):3-19. doi: 10.1002/mus.20057.'}], 'seeAlsoLinks': [{'url': 'http://www.anodynetherapy.com', 'label': 'website of company that provided device to be studied'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy. The hypothesis of the study was that the percentage of subjects with at least 40% improvement in visual analog scale score for pain after 4 weeks of treatment is higher for Monochromatic Near-infrared Photoenergy (MIRE) treatment than for sham treatment.', 'detailedDescription': 'Pain is a very common symptom, between 65-80%, in patients with peripheral neuropathy. This study is designed to evaluate the effectiveness of monochromatic near infrared photoenergy therapy (MIRE) in the treatment of pain in axonal peripheral neuropathy. This will be compared with a placebo (sham) device.\n\nThe MIRE is a FDA approved, drug-free, non-invasive, medical therapeutic device that uses near-infrared light emitting diodes to deliver monochromatic near infrared photoenergy (MIRE) through contact with the skin. The effect of MIRE is believed to increase local blood circulation by dilating vessels and to reduce pain by decreasing local swelling and inflammation. MIRE is also thought to increase local levels of nitric oxide (NO) which may decrease pain levels.\n\nStudy subjects will receive treatment with the device or the placebo device 3 times per week for 4 weeks. Response will be measured during and after the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ages 18-85; able to give informed consent\n* Documented painful, distal peripheral neuropathy of idiopathic cause, or related to impaired glucose tolerance or diabetes mellitus.\n* Neuropathy documented by one of the following studies: nerve conduction studies and needle electromyography (EMG); quantitative sensory testing of the foot with Computer Aided Sensory Evaluator (CASE IV); quantitative sudomotor axon reflex test (Quantitative Sweat MeasurementSystem \\[Q-Sweat\\]); neurology specialty examination; and neuropathy impairment score (NIS) of less than 25.\n* Stable pharmacotherapy for neuropathic pain for at least two weeks.\n* Optimal pharmacotherapy has been achieved.\n* Subjects cannot be on Cyclooxygenase-2 (COX 2) inhibitors\n* Pain Visual Analog Scale (VAS) of greater than or equal to 4/10\n* Subject has provided written informed consent\n* Not currently using transcutaneous electrical nerve stimulation (TENS)\n* Not currently receiving acupuncture\n\nExclusion Criteria:\n\n* Pregnant or likely to become pregnant\n* Current diagnosis of cancer\n* Neuropathy impairment score (NIS) of greater than 25.\n* Diagnosis of severe neuropathy of known etiology for which specific treatment is available (i.e., acute and chronic inflammatory polyradiculoneuropathies, vasculitis, B 12 deficiency).\n* Unstable diabetes mellitus defined as a hemoglobin A1c (HbA1c) greater than 9%, and/or 10% of fasting blood sugars greater than 300 mg/dl for the week prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT00125268', 'briefTitle': 'Near Infrared Light for the Treatment of Painful Peripheral Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Phase III, Double Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Adjunct Monochromatic Near-infrared Photoenergy (MIRE) in Patients With Painful Axonal Peripheral Neuropathy', 'orgStudyIdInfo': {'id': '927-05 00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MIRE', 'description': 'Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).', 'interventionNames': ['Device: MIRE']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.', 'interventionNames': ['Device: Sham Device']}], 'interventions': [{'name': 'MIRE', 'type': 'DEVICE', 'otherNames': ['Anodyne Therapy System'], 'description': 'Monochromatic near infrared photo energy (MIRE). A 30-minute application of MIRE results in a radiant exposure of 43.2 joules per square centimeter (J/cm\\^2). The design of the flexible pads allows the infrared energy to be delivered perpendicular to and in contact with the involved site. MIRE applied to the skin facilitates the release of a small molecule of the free radical nitric oxide from hemoglobin and other proteins in surrounding tissue. Increased levels of nitric oxide improve the circulation of blood enhancing wound healing and reducing pain.', 'armGroupLabels': ['MIRE']}, {'name': 'Sham Device', 'type': 'DEVICE', 'description': 'The sham device is non-active but otherwise identical to the study device.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85254', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Matthew A Butters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anodyne Therapy, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Matthew Butters, M.D. Principal Investigator', 'oldOrganization': 'Mayo Clinic'}}}}