AzTrials
AzTrials

Neuropathic PainNCT03890315

Evaluation of Neuropathic Pain in the Context of Clinical Symptoms, Quantitative Sensory Tests and Imaging With FMRI

An observational study of Neuropathic Pain and Radiculopathy, Cervical, run by Ege University at 1 site in Turkey (Türkiye).

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

This study is planned to evaluate patients with upper extremity neuropathic pain due to cervical radiculopathy with clinical symptoms, Quantitative Sensory Testing(QST) and Functional Magnetic Resonance Imaging(fMRI). Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Neuropathic Pain, Radiculopathy, Cervical
What is being tested?
Functional MRI
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 Apr 2019to 7 Apr 2020
Phase
Observational
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult patients with upper extremity neuropathic pain due to radiculopathy Duration of >1 month Unilateral extremity pain will be included in the study. Patients will then be stratified according to their total Scores in PainDetect, and neuropathic pain probable or not probable patients will be compared in analyses.

Who may be able to join

  • Adult patients with upper extremity neuropathic pain due to radiculopathy Duration of >1 month Unilateral extremity pain

Who cannot join

  • Severe cognitive impairment
  • Unstable systemic comorbidity
  • Presence of pacemaker or deep brain stimulation
  • Implants that aren't compatible with MRI
  • Claustrophobia
  • Complete or near complete loss of sensation
  • Brain injury or presence intracranial lesions

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ege university school of medicine

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Patients With Neuropathic Pain in the Context of Clinical Symptoms, Quantitative Sensory Tests and Imaging With FMRI

This study is planned to evaluate patients with upper extremity neuropathic pain due to cervical radiculopathy with clinical symptoms, Quantitative Sensory Testing(QST) and Functional Magnetic Resonance Imaging(fMRI). Patients with similar charactheristics will be grouped and comparisons will be conducted in fMRI results, as well as QST.

Read the detailed description

Neuropathic pain is a type of pain which usually accompanies injuries or conduction defects in the central or peripheral nervous system, as well as receptors. Unlike the other types of pain, neuropathic ones are more resistant to therapy and prone to be chronic.

In recent years, there are many novel techiques to assess the neurological status and create standardized test protocols. One of these techiques is QST(Quantitative Sensory Testing). QST is a specific type of sensory examination, usually done through computerized stimuli of heat, cold or vibration, or specific test equipment. There are many types of QST protocols around the world, and their results can also be expressed as phenotypes through statistics. While there are 3 types of pain phenotypes with the 13 item QST protocol suggested by German Neuropathic Pain Research group(DFNS), all patient groups can be classified differently as well, according to the common findings they express. These different phenotypes are also shown to have different responses to the different pain treatments. Such differences are usually attributed to the different mechanisms and fibers underlying the pathogenesis.

While patients show differences in QST results, evidence for the correlation between these variables and clinical symptoms of the patients are still scarce. Moreover, it is still yet to be known if these differences have a central origin as well as the peripheral mechanisms.

Functional Magnetic Resonance Imaging(fMRI) is a method to evaluate cerebral functions. It is mainly based on the blood flow changes that occur locally in regions that are in function[5]. As a result of the increased blood flow, the oxygen concentration also increases, creating a signal response called BOLD(Blood Oxygen Level Dependent) response. Since different types of pain are conducted through different fibers and pathways, it is also probable that they might show changes in cortical response as well.

In this study, the aim is to find whether QST results are correlated to clinical symptoms and pain properties of the patients, and these changes are related to the changes in the central nervous system

Being tested
Functional MRI
Medical subject headings
Neuralgia, Radiculopathy

What participants receive

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

  • Functional MRIDiagnostic test

    In fMRI, patients will first be taking a resting state phase in case of activations. In the block design phase, they will be given tactile stimuli in affected extremity, and then healthy extremity in 3 blocks, followed by pauses.

    Primary and secondary sensorial cortex, insular cortex, anterior cingulate cortex, preforntal cortex and amygdala activation will be chosen as regions of interest, and their activation will be recorded for analyses.

Study groups in NCT03890315
Study groupRoleWhat they receive
Neuropathic painAdult patients with upper extremity neuropathic pain due to radiculopathy Duration of >1 month Unilateral extremity pain will be recruited
Receives: Diagnostic Test: Functional MRI
ControlAge and gender matched control patients will also be recruited to show whether differences exist in outcome measures.
Receives: Diagnostic Test: Functional MRI

What is being measured

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

  1. Functional MRI BOLD responses

    In fMRI, patients will first be taking a resting state phase in case of activations. In the block design phase, they will be given tactile stimuli in affected extremity, and then healthy extremity in 3 blocks, followed by pauses in 10 second blocks.

    Measured: Baseline

Secondary outcomes (2)

  1. QST(Quantitative Sensory Testing) parameters

    QST is planned to be conducted with Case IV system(WR medical Electronics Co. Inc, Maplewood, Minnesota). Their cold threshold, heat threshold, vibration threshold and heat pain threshold will be recorded according to 4,2,1 protocol in both upper extremities. Cold threshold and heat threshold will be expressed as the difference from the skin temperature, expressed as centigrate degrees, through stimuli that are increased or decreased stepwise. For vibration threshold, the stepwise protocol will also be applied, and the results will be recorded as the amplitude of the vibration(micrometers), keeping the frequency constant as 125 Hz. Heat pain threshold will be measured similar to heat sensitivity threshold, and the first painful stimuli and the stimuli which evoked a numeric scale of 5 will be recorded as centigrate degrees(difference from obtained skin temperature).

    Measured: Baseline

  2. PainDETECT Questionnaire scores

    Patients will be evaluated for the properties of their neuropathic pain with the "PainDetect" inventory, a screening questionnaire. It is composed of questions regarding pain intensity (three numeric rating scales, pain course pattern, a pain drawing reflecting pain radiation, and seven questions addressing somatosensory phenomena which the patient rates on a six-category Likert scale (never-very strongly). A score ranging between 0 and 38, based on the patient's answers in the questionnaire, is calculated. For diagnostic purposes, a validated algorithm has been developed. A painDETECT score ≥19 indicates that a neuropathic pain component is likely, a score of 13-18 is considered uncertain, and a score ≤12 indicates that a neuropathic pain component is unlikely; resulting in three categories of patient pain characteristics.

    Measured: Baseline

Timeline

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

  1. First posted26 Mar 2019
  2. Study start26 Apr 2019
  3. Primary completion7 Apr 2020
  4. Study completion7 Apr 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03890315
Sponsor's protocol ID
QST-FMRI
Status last verified
Apr 2020
First submitted
22 Mar 2019
Last updated
30 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.

    PubMed 22019149

  • Magerl W, Krumova EK, Baron R, Tolle T, Treede RD, Maier C. Reference data for quantitative sensory testing (QST): refined stratification for age and a novel method for statistical comparison of group data. Pain. 2010 Dec;151(3):598-605. doi: 10.1016/j.pain.2010.07.026. Epub 2010 Oct 20.

    PubMed 20965658

  • Vollert J, Maier C, Attal N, Bennett DLH, Bouhassira D, Enax-Krumova EK, Finnerup NB, Freynhagen R, Gierthmuhlen J, Haanpaa M, Hansson P, Hullemann P, Jensen TS, Magerl W, Ramirez JD, Rice ASC, Schuh-Hofer S, Segerdahl M, Serra J, Shillo PR, Sindrup S, Tesfaye S, Themistocleous AC, Tolle TR, Treede RD, Baron R. Stratifying patients with peripheral neuropathic pain based on sensory profiles: algorithm and sample size recommendations. Pain. 2017 Aug;158(8):1446-1455. doi: 10.1097/j.pain.0000000000000935.

    PubMed 28595241

  • Holbech JV, Bach FW, Finnerup NB, Jensen TS, Sindrup SH. Pain phenotype as a predictor for drug response in painful polyneuropathy-a retrospective analysis of data from controlled clinical trials. Pain. 2016 Jun;157(6):1305-1313. doi: 10.1097/j.pain.0000000000000563.

    PubMed 27007067

  • Adam A, Dixon AK, Gillard JH, Schaefer-Prokop C, Grainger RG, Allison DJ. Grainger & Allison's Diagnostic Radiology E-Book: Elsevier Health Sciences; 2014.

Questions about this trial

What is this clinical trial studying?

An observational study of Neuropathic Pain and Radiculopathy, Cervical, run by Ege University at 1 site in Turkey (Türkiye).

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 1 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 30 Apr 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 Turkey (Türkiye). 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.

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?

Functional MRI BOLD responses (time frame: Baseline). 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 NCT03890315, which also lists 5 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 30 Apr 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