AzTrials
AzTrials

Chronic PainPhase 4NCT02747940

Neurologic Signatures of Chronic Pain Disorders

A Phase 4 study testing flunarizine and/or pregabalin in people with Chronic Pain and Chronic Migraine, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

"Brain signatures" as objective measures of acute pain have been characterized with functional magnetic resonance image and machine learning technology. As compared to acute pain, chronic pain leads to greater socioeconomic burden. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Pain, Chronic Migraine, Fibromyalgia
What is being tested?
flunarizine and/or pregabalin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTaiwan
Study dates
Dec 2015to Dec 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Headache Center, Teipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

About this study

"Brain signatures" as objective measures of acute pain have been characterized with functional magnetic resonance image and machine learning technology. As compared to acute pain, chronic pain leads to greater socioeconomic burden. However, measures for chronic pain remain subjective and suboptimal, and the brain signatures for chronic pain are largely unknown. Chronic migraine and fibromyalgia are two prototypes primary chronic pain disorders with high disability and intractability with prevalence of around 2% for both diseases. These two chronic pain disorders have shared clinical presentations (abnormal pain sensitivity, mood and sleep disorders), pathophysiology (central sensitization) and medical treatment (anti-depressants), despite different body parts are involved (head vs. whole body). The present integrated project aims to characterize both common and disease-specific brain signatures of chronic pain by investigating these two chronic pain disorders. Our findings may shed some light on the key mechanisms of pain chronification, and may pave the way for the optimization of diagnosis and prognostication, as well as formulation of personalized medicine in chronic pain, so as to improve life quality of these patients and to reduce socioeconomic loss.

The present project includes three interdisciplinary sub-projects (plus one animal study, not listed here):

Read more

A: Clinical studies for chronic migraine and fibromyalgia: endophenotypes and pain chronification B: Functional neuroimaging of chronic pain: multimodal quantitative analysis of brain connectomes C. Data stream mining technology for multimodal physiological signals of chronic pain: real-time tracking and clinical correlation

The specific aims of the present projects include:

  1. Identification of common and disease-specific brain signatures for chronic pain (sub-projects A, B, C)
  2. Investigation of clinical indicators with predictive values by machine learning analysis of big data (sub-projects A, B, C)
  3. Elucidation of the specific anatomical structures or neural networks underpinning pain chronification based on clinical neuroimaging (sub-projects A, B) In this 1st-year pilot study of the 4-year longitudinal study, we will establish experimental platforms for each sub-project, start to recruit participants and perform endophenotyping, as well as have a preliminary integration for sub-projects A, B and C.
Being tested
flunarizine and/or pregabalin
Medical subject headings
Chronic Pain, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • flunarizine and/or pregabalinDrug

Study groups in NCT02747940
Study groupRoleWhat they receive
patients with chronic migraineExperimentalflunarizine for patients with chronic migraine
Receives: Drug: flunarizine and/or pregabalin
patients with fibromyalgiaExperimentalpregabalin for patients with fibromyalgia
Receives: Drug: flunarizine and/or pregabalin
patients with chronic migraine and fibromyalgiaExperimentalflunarizine and pregabalin for patients with chronic migraine and myalgia
Receives: Drug: flunarizine and/or pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical improvement after treatment (1) headache/pain intensity [NRS, numeric rating scale]

    clinical improvement (headache/pain intensity) after treatment unit: NRS (numeric rating scale, 0-10) analysis: comparing the mean headache/pain intensity in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)

    Measured: 4 months

  2. clinical improvement after treatment (2) headache/pain frequency [attacks per month]

    clinical improvement (headache/pain frequency) after treatment unit: attacks per month analysis: comparing the mean headache/pain frequency in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)

    Measured: 4 months

  3. clinical improvement after treatment (3) headache/pain duration [hours per day]

    clinical improvement (headache/pain duration) after treatment unit: hours/day analysis: comparing the mean headache/pain duration (hours/day) in each month after treatment (M1/M2/M3/M4) to that before treatment (M-1)

    Measured: 4 months

Secondary outcomes (3)

  1. EEG change after treatment

    Linear and nonlinear analysis of EEG before and after treatment

    • Three EEG session will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 2-month/4-month treatment course, respectively.
    • The EEG analyses include linear (eg: power spectrum, coherence, functional connectivity) analyses as well as non-linear (eg: entropy) analyses.

    Measured: 4 months

  2. sensory and pain threshold change after treatment

    Using quantitative sensory testing (QST) to evaluate the sensory and pain threshold before and after treatment

    • Three QST session will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 2-month/4-month treatment course, respectively.
    • Equipment: electric von Fray filaments
    • unit: gram

    Measured: 2 months

  3. Autonomic function change after treatment

    Using heart rate variability (HRV) to evaluate autonomic function before and after treatment

    • Three HRV session will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 2-month/4-month treatment course, respectively.
    • The HRV analyses include time-domain (eg: mean heart rate and its variation, mean R-R interval and its variation), and also frequency domain analysis (eg: power spectrum)

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747940
Sponsor's protocol ID
2015-10-001BC2015-11-001AC002B
Status last verified
Oct 2020
First submitted
1 Apr 2016
Last updated
2 Nov 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Wang YF, Tzeng YS, Pan LH, Ling YH, Chen SP, Chen WT, Lai KL, Liu HY, Wang SJ. Higher Circulating IL-6 levels as a predictor for poor outcome after migraine preventive treatment: a prospective study. J Headache Pain. 2025 Nov 10;26(1):245. doi: 10.1186/s10194-025-02200-2.

    PubMed 41214533

  • Chuang CH, Li JY, King JT, Chen WT, Chen SP, Wang YF, Liu HY, Hsiao FJ, Pan LH, Wang SJ, Lai KL. Abnormal heart rate variability and its application in predicting treatment efficacy in patients with chronic migraine: An exploratory study. Cephalalgia. 2023 Oct;43(10):3331024231206781. doi: 10.1177/03331024231206781.

    PubMed 37851663

  • Pan LH, Chen WT, Wang YF, Chen SP, Lai KL, Liu HY, Hsiao FJ, Wang SJ. Resting-state occipital alpha power is associated with treatment outcome in patients with chronic migraine. Pain. 2022 Jul 1;163(7):1324-1334. doi: 10.1097/j.pain.0000000000002516. Epub 2021 Oct 13.

    PubMed 35708466

  • Pan LH, Wang YF, Ling YH, Lai KL, Chen SP, Chen WT, Treede RD, Wang SJ. Pain sensitivities predict prophylactic treatment outcomes of flunarizine in chronic migraine patients: A prospective study. Cephalalgia. 2022 Aug;42(9):899-909. doi: 10.1177/03331024221080572. Epub 2022 Apr 11.

    PubMed 35400174

  • Hsiao FJ, Chen WT, Liu HY, Wang YF, Chen SP, Lai KL, Hope Pan LL, Coppola G, Wang SJ. Migraine chronification is associated with beta-band connectivity within the pain-related cortical regions: a magnetoencephalographic study. Pain. 2021 Oct 1;162(10):2590-2598. doi: 10.1097/j.pain.0000000000002255.

    PubMed 34534180

  • Hsiao FJ, Chen WT, Ko YC, Liu HY, Wang YF, Chen SP, Lai KL, Lin HY, Coppola G, Wang SJ. Neuromagnetic Amygdala Response to Pain-Related Fear as a Brain Signature of Fibromyalgia. Pain Ther. 2020 Dec;9(2):765-781. doi: 10.1007/s40122-020-00206-z. Epub 2020 Oct 22.

    PubMed 33090368

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing flunarizine and/or pregabalin in people with Chronic Pain and Chronic Migraine, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical improvement after treatment (1) headache/pain intensity [NRS, numeric rating scale] (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02747940, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in