Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients
Recruitment status was Recruiting
The purpose of this study is to identify, prior to prescribing, which neuropathic pain patients will benefit from duloxetine more specific the investigators aims are to:
- Verify whether presence of chronic pain alters the pain modulation mechanisms, such as DNIC (diffuse noxious inhibitory control) and TS (temporal summation).
- Investigate whether anti-neuropathic medications such as duloxetine indeed change the pain modulation profile, and whether this profile change is associated with a reduction of clinical pain.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients Based on Assessment of Endogenous Analgesia Capabilities|
- Prediction of duloxetine pain relief efficacy by pre-treatment extent of the CPM response [ Time Frame: 2 year ] [ Designated as safety issue: No ]Regression model will assess predictive value of baseline pre-treatment extent of the CPM response and pain relief efficacy of duloxetine treatment.
- Treatment-related increase in CPM response [ Time Frame: 2 years ] [ Designated as safety issue: No ]We propose that treatment-related increase in CPM response will be correlated with duloxetine pain relief efficacy
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
The first week of the treatment is the placebo treatment. The effect of placebo will be taken into consideration for further evaluation the duloxetine effect on clinical pain and descending pain inhibition capabilities.
First week of placebo. then, initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks
Other Name: SSNRI
There is no accepted practice for selecting among recommended medications for the individual neuropathic pain patient. Guidelines published to date provided the evidence for their efficacy, however, data is not available on how to choose the right medication for the right patient in order to avoid long 'trial and error's. We hypothesize that medications affecting specific process of pain modulation will be more efficacious in patients expressing dysfunction of that specific process. Therefore, medications that enhance descending inhibition such as SSNRI will be more efficacious in patients with less-efficient pain inhibition. The latter is assessed by the conditioned pain modulation (CPM) paradigm. Accordingly, the aim of this study is to examine this hypothesis in painful diabetic neuropathy patients, using duloxetine, an SSNRI agent assumed to augment descending pain inhibition by reuptake inhibition of noradrenalin and serotonin in the spinal cord dorsal horn synapses. We expect to find better effect of duloxetine in those patients whose pain inhibition capability is less efficient, as expressed by their baseline CPM. Further, we aim to evaluate whether pro-nocieptive pattern of pain modulation indeed reverses in response to treatment. This will be explored by comparing the CPM responses before and after treatment, and by correlating pain alleviation with the possible changes in CPM.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363284
|Contact: David Yarnitsky,, Prof.||+972-4-8542605|
|Rambam Medical center||Recruiting|
|Contact: David Yarnitsky, Prof. +972-4-8542605|
|Principal Investigator: David Yarnitsky, Prof.|
|Principal Investigator:||David Yarnitsky, PhD||Rambam Health Care Campus|