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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02747940 |
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Date of registration:
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01/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neurologic Signatures of Chronic Pain Disorders
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Scientific title:
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Neurologic Signatures of Chronic Pain Disorders |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02747940 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Shuu-Jiun Wang, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neurological Institute, Taipei Veterans General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Control: devoid of any systemic or neurological diseases
- Chronic migraine: by ICHD-III (International Classification of Headache Disorder)
criteria
- Fibromyalgia: by ACR (American College of Rheumatology) 2010 criteria
Exclusion Criteria:
- history of major systemic illness, including uncontrolled hypertension, diabetes,
chronic renal insufficiency, autoimmune diseases or malignancies
- history of neurological disorders which might affect sensation such as previous stroke
or peripheral neuropathy
- history of substance abuse (except painkillers)
- heavy smokers (with a daily consumption >20 cigarettes)
- pregnancy or lactation
- any contraindication for magnetic resonance imaging (MRI)
- and any obvious infection or inflammation over a period of at least 1 month before the
study.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Migraine
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Chronic Pain
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Fibromyalgia
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Intervention(s)
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Drug: flunarizine and/or pregabalin
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Primary Outcome(s)
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clinical improvement after treatment (2) headache/pain frequency [attacks per month]
[Time Frame: 4 months]
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clinical improvement after treatment (1) headache/pain intensity [NRS, numeric rating scale]
[Time Frame: 4 months]
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clinical improvement after treatment (3) headache/pain duration [hours per day]
[Time Frame: 4 months]
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Secondary Outcome(s)
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EEG change after treatment
[Time Frame: 4 months]
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sensory and pain threshold change after treatment
[Time Frame: 2 months]
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Autonomic function change after treatment
[Time Frame: 2 months]
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Secondary ID(s)
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2015-10-001BC2015-11-001AC002B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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