Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04502251
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LDN and tDCS in Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D009271', 'term': 'Naltrexone'}, {'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-13', 'size': 292498, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2020-08-03T12:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double-blinded study, in which the participants and the outcomes assessor, who is the same as the investigator and the care provider, are blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized, double-blinded, parallel, controlled with placebo and sham stimulation, clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2020-07-25', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain in VAS', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'Visual Analogue Scale (VAS) that goes from 0 cm (without pain) to 10cm (worst pain).'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'Beck Depression Inventory (BDI-II) that goes from 0 (without depressive symptoms) to 63 (worst depressive symptoms)'}, {'measure': 'Anxiety levels', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'State-Trait Anxiety Inventory (STAI) divided into state anxiety (from 0 to 52, the higher the worse) and trait anxiety (from 0 to 48, the higher the worse)'}, {'measure': 'Pain Catastrophizing Thought', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'Pain Catastrophizing Scale (PCS): divided into rumination (from 0 to 16, the higher the worse), magnification (from 0 to 12, the higher the worse) and hopelessness (from 0 to 24, the higher the worse). Total goes from 0 to 52, the higher the worse'}, {'measure': 'Profile of Chronic Pain', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'Profile of Chronic Pain Scale (PCP:S): divided into Frequency and Intensity of Pain (from 0 to 30, the higher the worse), Pain Effect in Activities (from 0 to 36, the higher the worse) and Pain Effect in Emotions (from 0 to 25, the higher the worse)'}, {'measure': 'Pain Pressure Threshold', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'Pain Pressure Threshold (PPT) measured using an electronic algometer applied in the right forearm; and patients need to report the first pain sensation (minimum pain) and maximum pain. Threshold goes from 0 to the maximum value the patient can hold, the higher the value, better is the result'}, {'measure': 'Conditioned Pain Modulation', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': 'Conditioned Pain Modulation (CPM) with an algometer (PPT task), the patient informed when felt a pain equal to 6 in the VAS. This pain level was applied in the right forearm for 30 seconds, while the left forearm (non-dominant hand) was submerged in water from 0˚C to 1.5˚C; after 30s, patients reported their pain in each of the arms. CPM = left forearm VAS - 6. (from -4 to 6, the value must be as closest to -4 as possible, meaning the higher the worse)'}, {'measure': 'Serum BDNF', 'timeFrame': 'Change between baseline and after association (26 days from baseline)', 'description': "Blood sample collected and centrifuged, the supernatant aliquoted for BDNF analysis using ELISA technique, according to manufacturer's instructions (values start in 0, patients with fibromyalgia usually have higher levels of serum BDNF, therefore the higher the worse)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS', 'LDN', 'Transcranial Direct Current Stimulation', 'Low Dose Naltrexone'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '24737367', 'type': 'BACKGROUND', 'citation': 'Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.'}, {'pmid': '23794640', 'type': 'BACKGROUND', 'citation': 'van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.'}, {'pmid': '10600241', 'type': 'BACKGROUND', 'citation': 'Chapman CR, Nakamura Y. A passion of the soul: an introduction to pain for consciousness researchers. Conscious Cogn. 1999 Dec;8(4):391-422. doi: 10.1006/ccog.1999.0411.'}, {'pmid': '17350675', 'type': 'BACKGROUND', 'citation': 'Yunus MB. Fibromyalgia and overlapping disorders: the unifying concept of central sensitivity syndromes. Semin Arthritis Rheum. 2007 Jun;36(6):339-56. doi: 10.1016/j.semarthrit.2006.12.009. Epub 2007 Mar 13.'}, {'pmid': '18848998', 'type': 'BACKGROUND', 'citation': 'Burgmer M, Pogatzki-Zahn E, Gaubitz M, Wessoleck E, Heuft G, Pfleiderer B. Altered brain activity during pain processing in fibromyalgia. Neuroimage. 2009 Jan 15;44(2):502-8. doi: 10.1016/j.neuroimage.2008.09.008. Epub 2008 Sep 24.'}, {'pmid': '16814691', 'type': 'BACKGROUND', 'citation': 'Harris RE, Gracely RH, McLean SA, Williams DA, Giesecke T, Petzke F, Sen A, Clauw DJ. Comparison of clinical and evoked pain measures in fibromyalgia. J Pain. 2006 Jul;7(7):521-7. doi: 10.1016/j.jpain.2006.01.455.'}, {'pmid': '27291641', 'type': 'BACKGROUND', 'citation': 'Sluka KA, Clauw DJ. Neurobiology of fibromyalgia and chronic widespread pain. Neuroscience. 2016 Dec 3;338:114-129. doi: 10.1016/j.neuroscience.2016.06.006. Epub 2016 Jun 9.'}, {'pmid': '18191990', 'type': 'BACKGROUND', 'citation': 'Yunus MB. Central sensitivity syndromes: a new paradigm and group nosology for fibromyalgia and overlapping conditions, and the related issue of disease versus illness. Semin Arthritis Rheum. 2008 Jun;37(6):339-52. doi: 10.1016/j.semarthrit.2007.09.003. Epub 2008 Jan 14.'}, {'pmid': '25667809', 'type': 'BACKGROUND', 'citation': 'Lobo CP, Pfalzgraf AR, Giannetti V, Kanyongo G. Impact of invalidation and trust in physicians on health outcomes in fibromyalgia patients. Prim Care Companion CNS Disord. 2014 Oct 9;16(5):10.4088/PCC.14m01664. doi: 10.4088/PCC.14m01664. eCollection 2014.'}, {'pmid': '25479148', 'type': 'BACKGROUND', 'citation': 'Fitzcharles MA, Ste-Marie PA, Mailis A, Shir Y. Adjudication of fibromyalgia syndrome: challenges in the medicolegal arena. Pain Res Manag. 2014 Nov-Dec;19(6):287-92. doi: 10.1155/2014/742830.'}, {'pmid': '2306288', 'type': 'BACKGROUND', 'citation': 'Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. 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Epub 2005 Jul 6.'}, {'pmid': '22631436', 'type': 'BACKGROUND', 'citation': 'Marlow NM, Bonilha HS, Short EB. Efficacy of transcranial direct current stimulation and repetitive transcranial magnetic stimulation for treating fibromyalgia syndrome: a systematic review. Pain Pract. 2013 Feb;13(2):131-45. doi: 10.1111/j.1533-2500.2012.00562.x. Epub 2012 May 28.'}, {'pmid': '27983739', 'type': 'BACKGROUND', 'citation': 'Zhu CE, Yu B, Zhang W, Chen WH, Qi Q, Miao Y. Effiectiveness and safety of transcranial direct current stimulation in fibromyalgia: A systematic review and meta-analysis. J Rehabil Med. 2017 Jan 19;49(1):2-9. doi: 10.2340/16501977-2179.'}, {'pmid': '18312584', 'type': 'BACKGROUND', 'citation': 'Boros K, Poreisz C, Munchau A, Paulus W, Nitsche MA. Premotor transcranial direct current stimulation (tDCS) affects primary motor excitability in humans. Eur J Neurosci. 2008 Mar;27(5):1292-300. doi: 10.1111/j.1460-9568.2008.06090.x. 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Prevalence of rheumatic diseases in adult population in Spain (EPISER 2016 study): Aims and methodology. Reumatol Clin (Engl Ed). 2019 Mar-Apr;15(2):90-96. doi: 10.1016/j.reuma.2017.06.009. Epub 2017 Jul 31. English, Spanish.'}, {'pmid': '24018611', 'type': 'BACKGROUND', 'citation': 'Bernardy K, Klose P, Busch AJ, Choy EH, Hauser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2.'}, {'pmid': '19453963', 'type': 'BACKGROUND', 'citation': 'Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Med. 2009 May-Jun;10(4):663-72. doi: 10.1111/j.1526-4637.2009.00613.x. Epub 2009 Apr 22.'}, {'pmid': '28684258', 'type': 'BACKGROUND', 'citation': 'Khedr EM, Omran EAH, Ismail NM, El-Hammady DH, Goma SH, Kotb H, Galal H, Osman AM, Farghaly HSM, Karim AA, Ahmed GA. Effects of transcranial direct current stimulation on pain, mood and serum endorphin level in the treatment of fibromyalgia: A double blinded, randomized clinical trial. Brain Stimul. 2017 Sep-Oct;10(5):893-901. doi: 10.1016/j.brs.2017.06.006. Epub 2017 Jun 23.'}, {'pmid': '17559710', 'type': 'BACKGROUND', 'citation': 'Boggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'Fibromyalgia is a complex generalized and diffuse musculoskeletal chronic pain; and pharmacological approaches are widely used to relieve pain and increase life quality. In this context, low-dose naltrexone (LDN) was able to increase nociceptive threshold in patients with fibromyalgia. Moreover, non-pharmacological techniques, like Transcranial Direct Current Stimulation (tDCS), have been shown effective for pain management. This study aims to evaluate the analgesic and neuromodulatory effect of combined LDN followed by tDCS in fibromyalgia patients. This is a randomized, double-blinded, parallel, placebo/sham-controlled trial, in which 92 (10% loss) women with fibromyalgia will be included included and signed the informed consent. Patients will be allocated into 4 groups: tDCS+LDN (n=21), Sham-tDCS+LDN (n=22), tDCS+Placebo (n=22), and Sham-tDCS+Placebo (n=21). LDN or placebo (p.o.) intervention lasts 26 days, in the last five, tDCS will be applied (sham or active, 20min, 2mA). Questionnaires assessed are: Sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Chronic Pain Profile Scale (CPP). Also, pain measures were taken: Pain Pressure Threshold (PPT) and Conditioned Pain Modulation (CPM). Blood samples will be collected to analyze Brain Derived Neurotrophic Factor (BDNF) serum levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed the consent form\n* women from 18 to 65 years\n* confirmed diagnosis of fibromyalgia according 2016 American College of Rheumatology criteria\n* read and write\n* pain higher than 6 in the Visual Analogue Scale (VAS), in the last 3 months\n* chronic stable treatment in the last 3 months.\n\nExclusion Criteria:\n\n* in use of opioid drugs;\n* pregnancy or not using anticontraceptive\n* history of alcohol or drug abuse in the last 6 months\n* history of neurological pathologies\n* history of arrhythmia\n* history of use of drugs that might change vascular response\n* history of head trauma\n* history of neurosurgery\n* decompensated systemic diseases or chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren syndrome, Reiter syndrome)\n* history of non-compensated hypothyroidism\n* personal history of cancer.'}, 'identificationModule': {'nctId': 'NCT04502251', 'briefTitle': 'LDN and tDCS in Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitario La Salle'}, 'officialTitle': 'Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia: Randomized Clinical Trial, Blind, Controlled With Placebo', 'orgStudyIdInfo': {'id': '70005317.5.0000.5307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LDN + tDCS', 'description': 'Low Dose Naltrexone and Transcranial Direct Current Stimulation', 'interventionNames': ['Drug: Low-Dose Naltrexone', 'Device: Transcranial Direct Current Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'LDN + Sham tDCS', 'description': 'Low Dose Naltrexone and Sham Transcranial Direct Current Stimulation', 'interventionNames': ['Drug: Low-Dose Naltrexone', 'Device: Sham Transcranial Direct Current Stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + tDCS', 'description': 'Placebo and Transcranial Direct Current Stimulation', 'interventionNames': ['Device: Transcranial Direct Current Stimulation', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Placebo + Sham tDCS', 'description': 'Placebo and Sham Transcranial Direct Current Stimulation', 'interventionNames': ['Drug: Placebo', 'Device: Sham Transcranial Direct Current Stimulation']}], 'interventions': [{'name': 'Low-Dose Naltrexone', 'type': 'DRUG', 'otherNames': ['LDN'], 'description': '4.5mg daily dose, orally, during 26 days', 'armGroupLabels': ['LDN + Sham tDCS', 'LDN + tDCS']}, {'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.', 'armGroupLabels': ['LDN + tDCS', 'Placebo + tDCS']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.', 'armGroupLabels': ['Placebo + Sham tDCS', 'Placebo + tDCS']}, {'name': 'Sham Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'otherNames': ['Sham tDCS'], 'description': 'Sham-tDCS stimulation consists of an active current during 30 seconds', 'armGroupLabels': ['LDN + Sham tDCS', 'Placebo + Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92010-000', 'city': 'Canoas', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Universidade La Salle', 'geoPoint': {'lat': -29.91778, 'lon': -51.18361}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitario La Salle', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andressa de Souza', 'investigatorAffiliation': 'Centro Universitario La Salle'}}}}