A Methodology Study Of Brain Imaging Of Pain-Killers In Post-Traumatic Neuropathic Pain Patients
Status
Completed
Conditions
Pain
Treatments
Drug: Pregabalin
Drug: Tramadol SR
Drug: Placebo
Details and patient eligibility
About
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.
Enrollment
18 patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Triple Blind
18 participants in 3 patient groups, including a placebo group
1
Placebo Comparator group
Treatment:
Drug: Placebo
2
Experimental group
Treatment:
Drug: Pregabalin
3
Experimental group
Treatment:
Drug: Tramadol SR
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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