Back to resultsThe Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Apomorphine
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
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
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
apomorphine
Normal saline
Arm Description
1.5 mg apomorphine, administered subcutaneously
saline, administered subcutaneously
Outcomes
Primary Outcome Measures
Experimental and clinical cold pain tolerance measured in seconds
Secondary Outcome Measures
Experimental and clinical cold pain threshold measured in seconds
Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)
Full Information
NCT ID
NCT02969629
First Posted
September 14, 2016
Last Updated
November 20, 2016
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02969629
Brief Title
The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
apomorphine
Arm Type
Experimental
Arm Description
1.5 mg apomorphine, administered subcutaneously
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
saline, administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Apomorphine
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
Experimental and clinical cold pain tolerance measured in seconds
Time Frame
Up to 120 minutes after drug administration
Secondary Outcome Measure Information:
Title
Experimental and clinical cold pain threshold measured in seconds
Time Frame
Up to 120 minutes after drug administration
Title
Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)
Time Frame
Up to 120 minutes after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elon Eisenberg, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
Learn more about this trial
The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain
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