The primary aim of the proposed multi-site study will be to determine internal and external validity of the proposed new diagnostic criteria.
ID
Source
Brief title
Condition
- Injuries by physical agents
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differnce in the Verschil occurence of signs and symptoms between boh patient
groups.
Secondary outcome
Pain questionnaire (McGill pain questionnaire - MPQ short form), quality of
life (SF-36), thermosensory assessment (TSA).
Background summary
A gold standard for the diagnosis of Complex Regional Pain Syndrome (CRPS) is
not available and therefore the diagnosis is based on the presence of signs and
symptoms. The criteria that are most often used worldwide are those of the
International Association for the Study of Pain (IASP). The IASP criteria have
been criticized for their lack of specificity, which may result in
overtreatment and heterogeneous study populations. Previous work suggests that
signs and symptoms of CRPS group into four relatively independent factors, only
three of which are currently used in diagnosis. Revised CRPS diagnostic
criteria have been proposed based on these four factors which appear to have a
better balance of diagnostic sensitivity and specificity than existing
criteria. The proposed adoption by the IASP of these revised diagnostic
criteria necessitates their further validation. In addition, the relationship
of these four diagnostic factors to hypothesized pathophysiological mechanisms
in CRPS is unknown, as is their utility in predicting treatment response.
The current proposal involves an international multi-center study that aims to
determine the internal and external validity of the proposed new diagnostic
criteria for Complex Regional Pain Syndrome type 1 (CRPS1). The department of
neurology of the LUMC is one of the ten participants in this study. The
objective is to enroll 25 patients with CRPS and 25 patients with other
neuropathic pain syndromes. Primary outcome measures involve the (difference
in) occurrence of certain signs and symptoms. Secondary variables include pain,
quality of life, and neurophysiologic parameters (detection threshold for cold
and warmth, pain thresholds for cold and warmth). Time investment for patients
is approximately 2 hours. The study does not pose any risks to patients.
Study objective
The primary aim of the proposed multi-site study will be to determine internal
and external validity of the proposed new diagnostic criteria.
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
In total less than 2 hours. Completing 2 questionnaires by the patient (20
minutes). Administering 3 instruments by the investigator (20 minutes).
Physical examination by the asssessor (30 minutes). Neurophysiologic assessment
(not painful, 20 minutes).
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
CRPS patients of 18 years and older meeting current IASP criteria.
Patients with radicular syndrome, diabethic neuropathy, postherpetic neuralgia) of 18 years and older.
No restrictions with respect to race or gender.
Exclusion criteria
With respect to both patient groups: patients with other syndromes that could account for the degree of pain and dysfunction.
Design
Recruitment
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 | NL20105.058.07 |