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Trial record 1 of 119 for:    "Neuromuscular Disease" | "Lidocaine"
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Lidocaine for Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT02363803
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
simon.haroutounian, Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Peripheral Neuropathy Pain Drug: lidocaine Drug: Placebo Not Applicable

Detailed Description:

Diabetic peripheral neuropathy [DPN] is caused by diabetes-related metabolic damage to the sensory nervous system. It affects more than 3 million Americans and is leading cause of nerve damage-associated pain worldwide. Currently approved drugs such as gabapentin, pregabalin, and duloxetine provide pain relief only in 1 out of 4 or 5 people with DPN, pointing to a great need to identify effective therapy for these patients. Recent literature suggests that certain methods of assessing sensory nerve function in neuropathic pain patients may provide prediction to individual analgesic response; however, no placebo-controlled studies have been performed with the primary goal of identifying treatment response predictors in DPN.

We propose in this study to examine whether sensory testing to determine mechanical pain threshold [MPT] or heat pain threshold [HPT] will predict the subject's response to IV lidocaine analgesic therapy. We hypothesize that people with painful DPN who have high MPT or HPT are more likely to respond to lidocaine treatment. This is a prospective, double blind, placebo-controlled study with the primary objective of determining whether the results from the sensory testing predict the response to systemic lidocaine in patients with painful DPN.

Consented subjects will attend a screening visit and two intervention visits, during which they will undergo sensory testing and receive intravenous lidocaine or placebo infusion in a cross-over design. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine the sequence of interventions: lidocaine and then placebo, or vice versa. An unblinded research nurse coordinator will be assigned to match the study number with randomized treatment sequence, and this person will prepare the study medications, which will look identical. This research nurse coordinator will not be involved at any stage at patient assessment or data analysis. The participants and all other study personnel will be blinded to the treatment allocation.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Predicting Individual Response to Analgesic Treatment in Painful Diabetic Neuropathy
Actual Study Start Date : February 2015
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Normal saline infusion
Intravenous infusion of normal saline over a 40 minute period.
Drug: Placebo
Normal saline, approved for hypovolemia, and homeostasis.

Active Comparator: Lidocaine infusion
Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.
Drug: lidocaine
lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.




Primary Outcome Measures :
  1. Change in spontaneous pain at 60-120 minutes after lidocaine infusion initiated (assessed on 0-10 NRS) [ Time Frame: Baseline compared to 60-120 minutes after starting the infusion ]
    Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.


Secondary Outcome Measures :
  1. Change in evoked mechanical and thermal sensation. [ Time Frame: - 60 minutes and + 60 minutes of initiating infusion ]
    Thermal and mechanical responses will be assessed before and after infusions. After infusion, this assessment will be performed every 10 minutes for 60 minutes.

  2. Change in NPSI (Neuropathic Pain Symptom Inventory) descriptors of pain from baseline to 60 min [ Time Frame: Baselline to 60 minutes of initiating infusion ]
    NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine and again at 60 minutes post-infusion. Change from baseline in total NPSI (Neuropathic Pain Symptom Inventory) score. The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.

  3. Change in Spontaneous Pain Intensity as a Function of Baseline MPT [ Time Frame: baseline to 60-120 minutes after starting the infusion ]
    Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.

  4. Change in Spontaneous Pain Intensity as a Function of Baseline HPT [ Time Frame: Baseline to 60-120 minutes after starting the infusion ]
    Correlation between Heat Pain Threshold (HPT in degrees Celcius) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18;
  2. Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose > 126 mg/dL and/or HbA1C >6.5%);
  3. Distal symmetric pain in lower extremities with duration of more than 3 months;
  4. Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.
  5. Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Exclusion Criteria:

  1. Not giving consent to participate in the study;
  2. Unable to complete self-report pain questionnaire;
  3. History of moderate to severe renal or liver failure;
  4. History of other central or peripheral neurologic disorders;
  5. History of cardiac arrhythmias;
  6. Contraindication to intravenous lidocaine;
  7. Pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363803


Locations
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United States, Missouri
Washington University School of Medicine/Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Simon Haroutounian, PhD Department of Anesthesiology, WUSTL

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Responsible Party: simon.haroutounian, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02363803     History of Changes
Other Study ID Numbers: 201412073
First Posted: February 16, 2015    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Peripheral Nervous System Diseases
Nervous System Diseases
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action