N/A
Completed N=18
A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients
Source: ClinicalTrials.gov NCT00610155 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals Across the Whole Brain |
— | — |
| PRIMARY 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) |
-17.3; 18.6; 7.4; 8.1; 23.3; 30.8 | — |
| PRIMARY 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) |
-22.3; -3.7; 0.2; -13.5; 18.2; 20.2 | — |
| PRIMARY Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Thermal Stimulation (TH) |
102.2; 92.5; 83.3; 92.1; 103.4; 118.7 | — |
| PRIMARY Voxel-wise Blood Oxygen Level Dependent (BOLD) Using fMRI of Brain Activation Signals in Defined Brain Regions in Response to Visual Stimulation (VIS) |
— | — |
| PRIMARY Arterial Spin Labelling (ASL) Using fMRI of Brain Activation Signals Across the Whole Brain and in Defined Brain Regions |
— | — |
| SECONDARY 36-Item Short-Form Health Survey (SF-36) |
— | — |
| SECONDARY Beck Depression Inventory (BDI) |
— | — |
| SECONDARY State and Trait Anxiety Questionnaire |
— | — |
| SECONDARY Pain Catastrophising Scale (PCS) |
— | — |
| SECONDARY Neuropathic Pain Symptom Inventory (NPSI) |
— | — |
| SECONDARY Daily Pain Score |
5.57; 5.28; 6.40; 5.46; 5.10; 6.33 | — |
| SECONDARY Present Pain Intensity Score (PPIS) |
5.54; 4.13; 5.83 | — |
| SECONDARY Doleur Neuropathic 4 (DN4) Score |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00610155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.