Actively Recruiting
SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Led by University of Rochester · Updated on 2026-04-23
190
Participants Needed
7
Research Sites
122 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
B
Beth Israel Deaconess Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy. The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC). This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks. Participants will: * Undergo a quantitative sensory testing (QST) exam. * Provide a blood sample. * Complete questionnaires on the computer. * Take the study drug as instructed.
CONDITIONS
Official Title
SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years old (inclusive).
- Diagnosis of peripheral neuropathic pain in both feet from generalized distal sensory polyneuropathy.
- Neuropathic pain present in feet for at least 6 months.
- At least one sensory sign on clinical exam: abnormal pinprick perception, allodynia, hyperalgesia, abnormal light touch, vibratory perception, or proprioception.
- Average worst daily foot pain intensity of 4 or greater and less than 10 on a 0-10 scale during screening.
- Able to understand and read English.
- Stable dosages of all pain medications or consistent use of non-pharmacologic treatments for at least 1 month and willing to maintain during study, except acetaminophen rescue.
- Stable cannabinoid product dosages for at least 1 month prior and willing to maintain dosage during study.
- Willing and able to complete electronic patient-reported outcomes at home using REDCap.
You will not qualify if you...
- Taking opioid medication with daily mean morphine equivalent over 30.
- Different foot pain diagnosis worse than neuropathic pain or that prevents accurate neuropathic pain rating.
- Central cause of neuropathic pain (e.g., demyelinating disease, spinal cord injury, Parkinson's disease).
- History of traumatic or surgical cause related to peripheral neuropathy features.
- Bilateral polyradiculopathy with distal symptoms.
- Acute polyneuropathy within 6 months prior to Visit 1.
- Autoimmune-mediated neuropathy unless stable and controlled.
- Charcot-Marie-Tooth disease causing nociceptive pain that confounds neuropathic pain assessment.
- Exposure to neurotoxic chemotherapy or certain HIV therapies less than 6 months before Visit 1.
- Duloxetine use at or above 60mg/day in past 6 months or within 1 week before screening.
- Pregabalin (≥300mg/day) or gabapentin (≥1200mg/day) use in past 6 months or within 1 week before screening.
- Previous use of both pregabalin (or gabapentin) and duloxetine at sufficient doses and durations without pain relief.
- Taking venlafaxine, buproprion, tramadol, or St. John's Wort, except allowed SSRIs or TCAs at specified dosages.
- Taking monoamine oxidase inhibitors.
- Taking CYP1A2 inhibitors or thioridazine.
- Having a spinal cord stimulator.
- Uncontrolled or unstable medical or psychiatric conditions making participation unsafe.
- Significant illness or surgery within 4 weeks of screening.
- Known hypersensitivity to pregabalin or duloxetine.
- Chronic kidney or liver disease deemed unsafe for participation.
- Excessive alcohol consumption.
- Illicit drug use in past year or planned use during study (except cannabinoids).
- Significant suicide risk or danger to self or others.
- Cognitive impairment or psychiatric conditions interfering with assessments.
- Amputation of lower limbs (except isolated toe amputations).
- Pregnant, planning pregnancy, or breastfeeding.
- Enrolled in another investigational medication or pain trial.
- Unable or unwilling to provide informed consent.
- Any other condition deemed unsafe or detrimental to study participation by investigator.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Beth Israel Deaconess Medical Center for Autonomic and Peripheral Nerve Disorders
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Not Yet Recruiting
3
University of Rochester
Rochester, New York, United States, 14618
Actively Recruiting
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Not Yet Recruiting
5
University of Utah
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
6
University of Vermont
Burlington, Vermont, United States, 05401
Actively Recruiting
7
VCU Medical Center
Richmond, Virginia, United States, 23298
Not Yet Recruiting
Research Team
R
Rachel De Guzman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
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