N/A
N=34
Lidocaine for Diabetic Peripheral Neuropathy
Diabetes · Peripheral Neuropathy · Pain
Bottom Line
View on ClinicalTrials.gov: NCT02363803 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS) — 33; 51 percentage of pain change from baseline — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lidocaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS) |
33; 51 | 0.03 sig |
| SECONDARY Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation. |
2; 4; 3; 3; 2; 2 | — |
| SECONDARY NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion |
3; 0; 3; 0; 2; 0 | — |
| SECONDARY Change in Spontaneous Pain Intensity as a Function of Baseline MPT |
.249; .063 | — |
| SECONDARY Change in Spontaneous Pain Intensity as a Function of Baseline HPT |
.023; -.151 | — |
Summary
Diabetic nerve pain [painful diabetic peripheral neuropathy] is a common medical problem with few reliably effective treatments. There is some evidence that sensory testing may help determine how individuals will respond to analgesic therapy. In this study, the investigators are evaluating the relationship between sensory testing and subject response to lidocaine infusion therapy.
Eligibility Criteria
Inclusion Criteria
- Age ≥18;
- Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose > 126 mg/dL and/or HbA1C >6.5%);
- Distal symmetric pain in lower extremities with duration of more than 3 months;
- Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.
- Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).
Exclusion Criteria
- Not giving consent to participate in the study;
- Unable to complete self-report pain questionnaire;
- History of moderate to severe renal or liver failure;
- History of other central or peripheral neurologic disorders;
- History of cardiac arrhythmias;
- Contraindication to intravenous lidocaine;
- Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT02363803). 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.