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The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain

NCT ID: NCT02969629

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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The study aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP). Patients received either apomorphine or placebo in a randomized double-blinded manner.

Detailed Description

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Although evidence suggests that dopaminergic systems are involved in pain processing, the efficacy of dopaminergic interventions in reducing pain remains questionable. This randomized, double blinded, placebo-controlled, cross-over study was aimed to explore the effect of the dopamine agonist apomorphine on spontaneous pain intensity and evoked cold clinical and experimental pain in patients with lumbar radicular neuropathic pain (NP).

Data was collected from 35 patients (18 men, mean age 56.2±13.1 years). The following five pain measures were tested before (baseline) and 30, 75 and 120 min subsequent to subcutaneous injection of 1.5 mg apomorphine or placebo in two separate sessions: spontaneous pain intensity, threshold and tolerance to cold pain in the most painful site in the affected leg and in a remote healthy site in the dominant hand.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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apomorphine

1.5 mg apomorphine, administered subcutaneously

Group Type EXPERIMENTAL

Apomorphine

Intervention Type DRUG

Normal saline

saline, administered subcutaneously

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Interventions

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Apomorphine

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Presence of radicular pain for at least 3 months;
2. Average pain level during the last week prior to enrollment \> 40 (0-100);
3. No use of a new analgesic drug within 30 days prior to entry to the study and
4. Adults who were capable of understanding the purpose and instructions of the study and signing an informed consent.

Exclusion Criteria

1. Pregnancy or breastfeeding;
2. Presence of Parkinson's disease or any other extra-pyramidal diseases;
3. History of allergy to the investigational drugs: Apomorphine or Domperidone;
4. History of polyneuropathy and
5. Respiratory depression, dementia, psychotic diseases or hepatic insufficiency
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Eisenberg Elon MD

Head of pain research unit, Institute of pain

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elon Eisenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0234-11-RMB

Identifier Type: -

Identifier Source: org_study_id