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

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT02969629

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Drug: Apomorphine Drug: Normal Saline	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effects of the Dopamine Agonist (Apomorphine) on Experimental and Clinical Pain in Patients With Chronic Radicular Pain: a Randomized, Double-blind, Placebo-controlled, Cross-over Study

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: apomorphine 1.5 mg apomorphine, administered subcutaneously	Drug: Apomorphine
Placebo Comparator: Normal saline saline, administered subcutaneously	Drug: Normal Saline

Arm

Intervention/Treatment

Experimental: apomorphine

1.5 mg apomorphine, administered subcutaneously

Drug: Apomorphine

Placebo Comparator: Normal saline

saline, administered subcutaneously

Drug: Normal Saline

Outcome Measures

Primary Outcome Measures

Experimental and clinical cold pain tolerance measured in seconds [Up to 120 minutes after drug administration]

Secondary Outcome Measures

Experimental and clinical cold pain threshold measured in seconds [Up to 120 minutes after drug administration]
Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100) [Up to 120 minutes after drug administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy or breastfeeding;
Presence of Parkinson's disease or any other extra-pyramidal diseases;
History of allergy to the investigational drugs: Apomorphine or Domperidone;
History of polyneuropathy and
Respiratory depression, dementia, psychotic diseases or hepatic insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator: Elon Eisenberg, MD, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eisenberg Elon MD, Head of pain research unit, Institute of pain, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT02969629

Other Study ID Numbers:

0234-11-RMB

First Posted:

Nov 21, 2016

Last Update Posted:

Nov 22, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Low Back Pain

Apomorphine

Study Results

No Results Posted as of Nov 22, 2016