Our primary objective is to determine the prevalence of neuropathic pain within one-year ICU survivors. A secondary objective is to compare patient and disease characteristics between patients reporting neuropathic versus other pain, in order to…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the prevalence of neuropathic pain in the study
population as measured with the Douleur Neuropathique 4 (DN4) questionnaire.
Besides 7 questions, this questionnaires contains also 3 items of short
physical examination of the painful area.
Secondary outcome
Not applicable.
Background summary
In critically-ill patients who have survived an intensive care unit (ICU)
admission, the reported prevalence of chronic pain is substantially higher than
in the general population. However, its etiology has not been studied.
Furthermore, it is unknown whether this pain has primarily nociceptive or
neuropathic characteristics. Discriminating between neuropathic pain and other
pain will provide clues regarding underlying pathophysiological mechanisms and
may guide improved treatment and preventive measures.
Study objective
Our primary objective is to determine the prevalence of neuropathic pain within
one-year ICU survivors. A secondary objective is to compare patient and disease
characteristics between patients reporting neuropathic versus other pain, in
order to gain insight in possible risk factors for the development of
neuropathic pain.
Study design
Given the (almost complete) lack of prior knowledge about the topic, our study
is designed as an observational pilot study. In a subgroup of patients
reporting pain one year after ICU discharge according to a standard written
survey that is already routinely distributed among ICU survivors in the
University Medical Center Utrecht (UMCU), we will identify individuals with
(possible) neuropathic symptoms using an additional questionnaire and simple
physical examination.
Study burden and risks
The presence of pain in one-year ICU survivors is determined by analysis of the
routine follow-up questionnaire used at the ICU of the UMCU (METC protocol
number 10-006). Patients with pain one year after ICU stay will be contacted by
telephone and asked if they want to participate in a study investigating the
nature of their pain. After obtaining spoken informed consent, patients will be
visited at home. After obtaining written informed consent, the DN4
questionnaire will then be used to determine presence or absence of neuropathic
pain. Patients are also asked to rate the intensity of their pain on the
numeric rating scale (NRS) and visual analogue scale (VAS). To determine
physical, and especially muscle, function, hand grip strength will be measured
using a grip strength dynamo meter. Furthermore, some other questionnaires will
be filled out during this visit; the EuroQol 5D-3L (EQ5D) investigating
health-related quality of life (HRQoL), the hospital anxiety and depression
scale (HADS), and the impact of event scale (revised) (IES-R) investigating
symptoms of post-traumatic stress. These questionnaire and measurements will
take approximately 30-45 minutes and are completely non-invasive.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Patient was 18 years or older at the time of ICU admission.
2. Length of stay in the ICU > 48 hours.
3. Recent address and vital (survivorship) status confirmed by follow-up survey.
4. Spoken informed consent from the patient is obtained during a telephone call
Subsequent written informed consent from patient will be obtained during the home visit (before performing measurements).
Exclusion criteria
Patients who are not competent to provide informed consent (i.e. patients with severe cognitive 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 | NL60310.041.16 |