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Completed

NCT Number: NCT02969629

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rambam Health Care Campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apomorphine

Drug

normal saline

Drug

Primary outcomes

  1. Experimental and clinical cold pain tolerance measured in seconds

    Time frame: Up to 120 minutes after drug administration

Secondary outcomes

  1. Experimental and clinical cold pain threshold measured in seconds

    Time frame: Up to 120 minutes after drug administration

  2. Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)

    Time frame: Up to 120 minutes after drug administration

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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