Chronic Low Back PainPhase 4NCT02969629
The Effects of Apomorphine on Experimental and Clinical Pain in Patients With Chronic Radicular Pain
A Phase 4 study testing Apomorphine and Normal Saline in people with Chronic Low Back Pain, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Apomorphine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Apomorphine, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApomorphineDrug
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| apomorphine | Experimental | 1.5 mg apomorphine, administered subcutaneously Receives: Drug: Apomorphine |
| Normal saline | Placebo comparator | saline, administered subcutaneously Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experimental and clinical cold pain tolerance measured in seconds
Measured: Up to 120 minutes after drug administration
Secondary outcomes (2)
Experimental and clinical cold pain threshold measured in seconds
Measured: Up to 120 minutes after drug administration
Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)
Measured: Up to 120 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eisenberg Elon MD, Rambam Health Care Campus
- Investigators
- Elon Eisenberg, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969629
- Sponsor's protocol ID
- 0234-11-RMB
- Status last verified
- Nov 2016
- First submitted
- 14 Sep 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02969629
- Acronym / sponsor ID
- 0234-11-RMB
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apomorphine | Experimental | Drug: Apomorphine1.5 mg apomorphine, administered subcutaneously |
| Normal saline | Placebo comparator | Drug: Normal Salinesaline, administered subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apomorphine | Drug | apomorphine |
| Normal Saline | Drug | Normal saline |
Primary outcome
Experimental and clinical cold pain tolerance measured in seconds
Time frame: Up to 120 minutes after drug administration
2 secondary outcomes
Experimental and clinical cold pain threshold measured in seconds
Time frame: Up to 120 minutes after drug administration
Spontaneous clinical pain intensity measured on a numeric pain scale (NPS, 0-100)
Time frame: Up to 120 minutes after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elon Eisenberg, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apomorphine and Normal Saline in people with Chronic Low Back Pain, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experimental and clinical cold pain tolerance measured in seconds (time frame: Up to 120 minutes after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.