Neuropathic Pain
Conditions
Keywords
Opioid induced hyperalgesia, Neuropathic pain, Opioids, Sciatica, Serotonin-norepinephrine reuptake inhibitor (SNRI)
Brief summary
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.
Interventions
DRUGMorphine
DRUGMilnacipran
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age. 2. Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician. 3. Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (\< 30 mg of oral morphine-equivalents per day). 4. Ability to understand the purpose and instructions of the study and to sign an informed consent. \-
Exclusion criteria
1.Diabetic Neuropathy 2.Pain in upper limbs 3.Receiving anti- depressants and/or anticonvulsants 4.Pregnant women 5.Inability to comply with study protocol. 6.Allergy to Opioids 7.A diagnosis of Raynaud's Syndrome 8.History of substance abuse \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathic pain intensity (NPS) | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heat pain intensity in a remote area (Opioid induced hyperalgesia) | 1 month | Heat pain sensitivity will be determined by the use of VAS units (0-100). We'll measure the intensity of pain in response to application of brief experimental heat pain. |
| The McGill Pain Questionnaire | At baseline and at the end of 4-week treatment period | Will be completed before and after treatment |
| Assessment of Adverse events | Ongoing throughout the entire study period, an expected average of 4 weeks. | A list of possible side effects from the administered drugs has been prepared and will be completed at all scheduled visits. In addition, patients will record AEs on daily basis. If needed patients can call and report adverse events by phone. |
Countries
Israel
Contacts
Primary ContactElon Eisenberg, MD
Outcome results
None listed