Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502251
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2020-07-25
Brief Title:
LDN and tDCS in Fibromyalgia
Sponsor:
Centro Universitario La Salle
Organization:
Centro Universitario La Salle
Study Overview
Official Title:
Association of Low Doses of Naltrexone and Transcranial Direct Current Stimulation in Fibromyalgia Randomized Clinical Trial Blind Controlled With Placebo
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 placebosham-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 tDCSLDN n21 Sham-tDCSLDN n22 tDCSPlacebo n22 and Sham-tDCSPlacebo n21 LDN or placebo po 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None