The primary aim of the proposed multi-site study is to determine if the CRPS Severity Score can be used as a clinical bedside tool to monitor CRPS change in symptoms over time, specifically progression or regression. Various interventions will occur…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The CRPS severity score is the primary study variable. The objective is to
evaluate the test-retest reliablity and the responsiveness of this score.
Secondary outcome
Correlation of the change in the CRPS severity score with those of the changes
in other instruments, such as pain intensity, other pain measures and the
SF-36.
Background summary
The current proposal involves an international multi-center study that aims to
develop a Complex Regional Pain Syndrome (CRPS) Severity Score as a clinical
tool to monitor disease progression. The department of neurology of the LUMC is
one of the 14 participants in this study. The recent pilot paper of our group
suggests the need for a CRPS severity score (CSS) to compliment the dichotomous
diagnosis. This should be designed to be simple and practical for any
practitioner in any setting with minimal and readily available equipment and
common *bedside technique*. The design we propose for empirical testing is
pragmatic in that it uses the same signs and symptoms used in the diagnosis of
the syndrome with a score for each item (coded 0 = absent, 1 = present) simply
added to form the CSS (0-16 range). Preliminary validation techniques were used
for the pilot/feasibility study which showed associations with pain intensity,
emotional distress, impaired functioning, objective sensory and physical
changes using the signs and symptoms CRPS database checklist and the Rand-36
Health Survey. On the basis of a post hoc analysis of the data used for
developing and re-validating the diagnostic criteria, and a 10 subject
prospective feasibility study, a slightly different formulation of the CSS
checklist will be used for this work, based on a balanced approach: a yes/no of
2 signs and 2 symptoms in each of the 4 CRPS factors for a total score of 16
possible points (highest score = worst severity of syndrome).
Study objective
The primary aim of the proposed multi-site study is to determine if the CRPS
Severity Score can be used as a clinical bedside tool to monitor CRPS change in
symptoms over time, specifically progression or regression. Various
interventions will occur between the two time points (separated by 3 months) to
assess the sensitivity of the evolving instrument to change.
Study design
The proposed study will use elements of both a prospective correlational design
and a case comparison design, and will use a coordinated multi-site data
collection system.
Study burden and risks
Taking part in this study involves only negigible risks and burden mainly
involves the investment of time.
There are 2 study moments of 75 minutes each for acute patients and patients
whose treatment is about to change (baseline, 12 weeks) and 3 study moments of
75 minutes for patients on stable management (baseline, 2 weeks, 12 weeks).
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Subjects who are 18 years or older, who have the cognitive abilities to understand the demands of the study, who have sufficient command of Dutch and who meet the provisional 2011 IASP CRPS Clinical Diagnostic Criteria (Revised) are included in the study. .
Exclusion criteria
Patients who do not meet the inclusion criteria, do not give informed consent and who have other conditions that may explain their signs and symptoms.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| CCMO | NL37789.058.11 |