The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT
ID
Source
Brief title
Condition
- Therapeutic and nontherapeutic effects (excl toxicity)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between active and placebo cream pain score on Numerical Rating
Scale
Secondary outcome
Feasibility of a randomised, doubleblind, placebo-controlled, cross-over study
with the folowing questions: effectiveness on the other rating scales,
percentage patients responding and will be included after the testing phase;
comprehensibility and completeness of questionnaires, percentage drop-outs,
side effects, logistics and randomization process, tolerance and safety of the
creams
.
Background summary
Neuropathic pain influences qualtiy of live, work, sleep and can lead towards
depression. Compliance of oral neuropathic painkillers after one year of
therapy is low (45%) probably due to less or low effectiveness and side effects
such as drowsiness and lack of concentration. Therefore new therapy strategies
to reduce neuropathic pain and negative impact of quality of life and society.
Poical analgetics are a interesting field to investigate, mainly due to local
influence on damaged nerve. The peripheral effect and if used as prescribed
without entering bloodstream as an active component central side effects are
rare.
Study objective
The purpose of this study is to investigate the effect size in order to perform
a power calculation for calculating a sample size for a powered RCT
Study design
Randomised, double blinded, placebo controlled cross over multicentre pilot
study
2 parts:
- double blinded placebo controlled cross over study with amitriptyline 10%
/placebo cream (1 week cream A, 1 week wash out,
1 week cream B)
- double blinded placebo controlled cross over study with ketamine 10% /
placebo cream (1 week cream A, 1 week wash out,
1 week cream B)
Intervention
local treatment with either ketamine 10% or amitriptyline 10% cream or placebo
Study burden and risks
Patients need to fill in some study forms (BPI, EQ5DL PGIC and specific cream
related questions).
There will be 1 or 2 extra visits for our patients in our pain clinic
Low risk during this study, local skin irritation is mentioned in <1% of active
cream users and the risk of hematoma as the result of blood collection
Maelsonstraat 3
Hoorn 1624NP
NL
Maelsonstraat 3
Hoorn 1624NP
NL
Listed location countries
Age
Inclusion criteria
- peripheral neuropathic pain (DOT: 130)
- >= 18 years old, competent
- >= 5 and <10 on the Visual Analogue Scale (VAS)
- max. 10% of the bodysurface
Exclusion criteria
- pregnancy or planned pregnancy during study period
- open wounds on the place of the neuropatic pain
- current use of topical analgetic
- presence of other painsyndromes, like the widespread painsyndrome
- presence of serious psychological or psyciatric morbidity
- addiction on intoxicans
- insufficient control of the Dutch language
- use of ketamine and amitriptyline
- known allergy of the studymedication (active substance en additives)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-005656-26-NL |
| CCMO | NL51748.094.15 |