Chronic Pain SyndromeNCT02197741
The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
An observational study of Chronic Pain Syndrome, run by Swiss Paraplegic Research, Nottwil.
Trial summary
An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Pain Syndrome
- What is being tested?
- opiate with bolus
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jul 2014
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: individuals with chronic pain syndrome
Who may be able to join
- chronic pain syndrome
- intrathecal opiate pump
- signed informed consent
Who cannot join
- younger than 18 years
- other (than opiate) intrathecal drug administration
- discontent with intrathecal opiate therapy
About this study
An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated.
Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment.
Read more
The following hypotheses were tested:
- The application of additional opiate boli results in significantly lower pain intensity.
- The application of additional opiate boli does not result in a higher rate of adverse Events.
- Conditions
- Chronic Pain Syndrome
- Being tested
- opiate with bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opiate with bolusDrug
| Study group | Role | What they receive |
|---|---|---|
| opiate without bolus | continuous opiate administration without bolus application Receives: Drug: opiate with bolus | |
| opiate with bolus | continuous opiate administration with additional bolus application Receives: Drug: opiate with bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
numeric rating scale from 0 to10
Measured: day 0. day 14, day 28
Secondary outcomes (2)
change in satisfaction with treatment outcome
numeric rating scale from 0 to 10
Measured: day 0, day 14, day 28
side effects
occurrence rate of side effects
Measured: from day 0 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Tim Reck, MD, Principal investigator, Center for Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197741
- Sponsor's protocol ID
- 2014-15
- Status last verified
- Nov 2016
- First submitted
- 4 Jul 2014
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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 Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
- ClinicalTrials.gov ID
- NCT02197741
- Acronym / sponsor ID
- 2014-15
- Conditions
- Chronic Pain Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jul 2014 (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.
An additional, intermittent bolus application in patients with intrathecal opiate administration for chronic pain syndrome may have a positive effect on the effectiveness of the treatment. Thus, the effect of an additional, intermittent bolus application in patients with intrathecal opiate administration was therefore investigated.
Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each patient was submitted to two treatment periods in randomly chosen order (cross-over design): 1. standard treatment (continuous opiate administration) and 2. continuous opiate administration with intermittent opiate bolus application. Both treatment periods lasted 14 days. Patients were asked to record pain intensity, side effects and satisfaction with the treatment.
The following hypotheses were tested:
- The application of additional opiate boli results in significantly lower pain intensity.
- The application of additional opiate boli does not result in a higher rate of adverse Events.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opiate without bolus | – | Drug: opiate with boluscontinuous opiate administration without bolus application |
| opiate with bolus | – | Drug: opiate with boluscontinuous opiate administration with additional bolus application |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- individuals with chronic pain syndrome
Key inclusion criteria (3 listed)
- chronic pain syndrome
- intrathecal opiate pump
- signed informed consent
Key exclusion criteria (3 listed)
- younger than 18 years
- other (than opiate) intrathecal drug administration
- discontent with intrathecal opiate therapy
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 |
|---|---|---|
| opiate with bolus | Drug | opiate with bolus, opiate without bolus |
Primary outcome
change in pain intensity
Time frame: day 0. day 14, day 28
numeric rating scale from 0 to10
2 secondary outcomes
change in satisfaction with treatment outcome
Time frame: day 0, day 14, day 28
side effects
Time frame: from day 0 to day 28
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.
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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.
Tim Reck, MD principal investigator
Center for Pain Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain Syndrome, run by Swiss Paraplegic Research, Nottwil.
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 3 inclusion and 3 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
change in pain intensity (time frame: day 0. day 14, day 28). 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.