Chronic Pain Syndrome
Conditions
Brief 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. 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.
Interventions
DRUGopiate with bolus
Sponsors
Swiss Paraplegic Research, Nottwil
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* chronic pain syndrome * intrathecal opiate pump * signed informed consent
Exclusion criteria
* younger than 18 years * other (than opiate) intrathecal drug administration * discontent with intrathecal opiate therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in pain intensity | day 0. day 14, day 28 | numeric rating scale from 0 to10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in satisfaction with treatment outcome | day 0, day 14, day 28 | numeric rating scale from 0 to 10 |
| side effects | from day 0 to day 28 | occurrence rate of side effects |
Outcome results
None listed