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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969629
• Other study ID #: 0234-11-RMB
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2016
• Last updated: November 20, 2016
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2016
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Apomorphine

• Normal Saline

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experimental and clinical cold pain tolerance measured in seconds		Up to 120 minutes after drug administration	No
Secondary	Experimental and clinical cold pain threshold measured in seconds		Up to 120 minutes after drug administration	No
Secondary	Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)		Up to 120 minutes after drug administration	No