Clinical trial NCT00610155: A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients
Official title: A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
First posted: 2008-02-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fMRI and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol SR in a cross-over clinical study design.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes.
* Brush allodynia score of ≥4 and calculated average pain score of ≥3 on an 11-point numerical rating scale by the completion of down-titration of existing medications.
* Right-handed

Exclusion Criteria:

* Subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery).
* Phantom limb pain, painful diabetic neuropathy.
* Subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from NeP of peripheral origin.
* Subjects with diabetes mellitus and with an HbA1C value of \>10% upon measurement at screening.

Primary outcomes:
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain
timeFrame: Day 8, 22, 36
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Affected Side (DMAa)
timeFrame: Day 8, 22, 36
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Dynamic Mechanical Allodynia of the Control Side (DMAc)
timeFrame: Day 8, 22, 36
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH)
timeFrame: Day 8, 22, 36
measure: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS)
timeFrame: Day 8, 22, 36
measure: Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions
timeFrame: Day 8, 22, 36
Secondary outcomes:
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: Day 8, 22, 36
measure: Beck Depression Inventory (BDI)
timeFrame: Day 8, 22, 36
measure: State and Trait Anxiety Questionnaire
timeFrame: Day 8, 22, 36
measure: Pain Catastrophising Scale (PCS)
timeFrame: Day 8, 22, 36
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Baseline (Day -7), Day 8, 22, 36
measure: Daily Pain Score
timeFrame: Day -35 through Day 36
measure: Present Pain Intensity Score (PPIS)
timeFrame: Day 8, 22, 36
measure: Doleur Neuropathic 4 (DN4) Score
timeFrame: Day -35
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Solihull
country: United Kingdom
facility: Pfizer Investigational Site
state: West Midlands
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: