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

NCT ID: NCT03890315

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-26

Study Completion Date

2020-04-07

Brief Summary

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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.

Detailed Description

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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

Conditions

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Neuropathic Pain Radiculopathy, Cervical

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Neuropathic pain

Adult patients with upper extremity neuropathic pain due to radiculopathy Duration of \>1 month Unilateral extremity pain will be recruited

Functional MRI

Intervention Type DIAGNOSTIC_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.

Control

Age and gender matched control patients will also be recruited to show whether differences exist in outcome measures.

Functional MRI

Intervention Type DIAGNOSTIC_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.

Interventions

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Functional MRI

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Göksel Tanıgör M.D.

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege university school of medicine

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22019149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20965658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28595241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27007067 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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QST-FMRI

Identifier Type: -

Identifier Source: org_study_id

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