Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica

Phase 2UnknownNCT01914042

Rambam Health Care Campus150 enrolled

Overview

Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Neuropathic Pain

Interventions

MorphineDRUG

MilnacipranDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Rambam Health Care Campus

Haifa, Israel

RECRUITING

Outcomes

Primary Outcomes

Neuropathic pain intensity (NPS)

Time frame: 1 month

Secondary Outcomes

Heat pain intensity in a remote area (Opioid induced hyperalgesia)

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.

Time frame: 1 month

The McGill Pain Questionnaire

Will be completed before and after treatment

Time frame: At baseline and at the end of 4-week treatment period

Assessment of Adverse events

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.

Time frame: Ongoing throughout the entire study period, an expected average of 4 weeks.

Central Contacts

Elon Eisenberg, MD

CONTACT

972 4 8542880 e_eisenberg@rambam.health.gov.il

Data from ClinicalTrials.gov

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