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

NCT03890315 | Completed

• 1 other identifier: QST-FMRI
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). Patients with similar charactheristics will be grouped and comparisons will be conducted in fMRI results, as well as QST.

Conditions

Neuropathic Pain; Radiculopathy, Cervical

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (2)

• QST(Quantitative Sensory Testing) parameters

  Baseline

• PainDETECT Questionnaire scores

  Baseline

Study Arms (2)

Neuropathic pain

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

Diagnostic Test: Functional MRI

Control

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

Diagnostic Test: Functional MRI

Interventions

Functional MRI 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; Neuropathic pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege university school of medicine

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 22019149 BACKGROUND

• 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.

  PMID: 20965658 BACKGROUND

• 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.

  PMID: 28595241 BACKGROUND

• 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.

  PMID: 27007067 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Neuralgia; Radiculopathy

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 26, 2019
• Study Start: April 26, 2019
• Primary Completion: April 7, 2020
• Study Completion: April 7, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

TU (1)