Prediction of Inter-individual Differences in the Response to Morphine by Psychophysical Assessment of Pain Enhancing and Inhibiting Mechanisms in Patients With Chronic Neuropathic Pain
Overview
- Phase
- Phase 2
- Intervention
- Morphine
- Conditions
- Neuropathic Pain
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Neuropathic pain intensity (NPS)
- Last Updated
- 7 years ago
Overview
Brief Summary
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.
Investigators
Eisenberg Elon MD
Director, Pain Research Unit
Rambam Health Care Campus
Eligibility Criteria
Inclusion Criteria
- •Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
- •Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
- •Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (\< 30 mg of oral morphine-equivalents per day).
- •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
Arms & Interventions
Morphine
Morphine in changing dosages (range between 10-60 mg twice a day). Opioid titration proceeds as follows: starting at an oral dose of 10 mg twice per day, followed every 5 days by a dose increase of 10 mg twice per day until (1) adequate analgesia had been achieved (as determined by the patients), (2) side effects (severe sedation, nausea or vomiting, constipation, sleep disturbances) limited further titration, or (3) a total of 120 mg per day had been reached.
Intervention: Morphine
Milnacipran
Milnacipran (Ixel)- a serotonin-norepinephrine reuptake inhibitor (SNRI), will be administrated in changing dosages (range between 12.5-75 mg twice daily). SNRI titration proceeds as follows: starting at an oral dose of 12.5 mg twice per day, followed every 5 days by a dose increase of 12.5 mg twice per day until (1) adequate analgesia had been achieved (as determined by the patients), (2) side effects (severe sedation, nausea or vomiting, constipation, sleep disturbances) limited further titration, or (3) a total of 150 mg per day had been reached.
Intervention: Milnacipran
Outcomes
Primary Outcomes
Neuropathic pain intensity (NPS)
Time Frame: 1 month
Secondary Outcomes
- Heat pain intensity in a remote area (Opioid induced hyperalgesia)(1 month)
- The McGill Pain Questionnaire(At baseline and at the end of 4-week treatment period)
- Assessment of Adverse events(Ongoing throughout the entire study period, an expected average of 4 weeks.)