Primary: to develop and validate a clinical prediction rule to predict a favourable or unfavourable disease course for NP patients, therewith enabling tailor made treatments for NP patients.Secondary: determine prevalence of clinical signs of NP in…
ID
Source
Brief title
Condition
- Other condition
- Peripheral neuropathies
Synonym
Health condition
laesie of ziekte van het somatosensorische systeem, aandoening van het centrale of perifere zenuwstelsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters:
severeness of pain, measured using the Numeric Rating Scale (NRS)
severeness of neuropathic pain, measured using the Neuropathic Pain Scale (NPS)
Secondary outcome
Secondary study parameters:
Signs of NP (hyper/hypoalgesia, deep pressure pain, hyper/hypoesthesia,
allodynia, vibration sense, joint position sense, two point discrimination),
measured using bedside-QST
Signs of sensory dysregulation, measured using diffuse noxious inhibitory
control (DNIC) and summation
Patient Global Impression of Change (PGIC)
Self Efficacy Scale
Disability Rating Index (DRI)
Impact on Participation and Autonomy (IPA)
Quality of Life, measured using SF-36 and Euroqol
Physical co-morbidity, measured using Cumulative Illness Rating Scale-Geriatric
(CIRS-G)
Depression / Trait anxiety, measured using Hospital Anxiety Depression Scales
(HADS)
Pain coping, measured using Pain Coping Inventory (PCI)
Catastrophizing, measured using Pain Catastrophizing Scale (PCS)
Fear of movement, measured using Tampa Scale for Kinesiophobia (TSK)
Age
Gender
Education
Treatment
Medical consumption
Work status
Social support
Background summary
Neuropathic Pain is a disorder that is difficult to define. Consequently,
described incidence rates vary and patient populations are heterogenous.
Because of this, getting uniformity on the prognosis and best medical treatment
of this disease is difficult. However, it is generally accepted that NP forms a
substantial problem in patient care, and consequences for the patients quality
of life, daily functioning and participation are severe.
Early evaluation of prognostic factors and uniformity in diagnosis and
treatment for patients with NP are necessary to improve medical care for these
patients. Development of a clinical prediction rule for NP may contribute to
identification of patients at risk for chronification, and enable tailor made
treatments for NP patients, therewith reduce patient and societal burden
associated with this disease.
Study objective
Primary: to develop and validate a clinical prediction rule to predict a
favourable or unfavourable disease course for NP patients, therewith enabling
tailor made treatments for NP patients.
Secondary: determine prevalence of clinical signs of NP in a general population
of pain patients of regional medical care centers; determine the relationship
between pain related variables at different levels of observation for NP
(cross-sectional and longitudinal).
Tertiary: implementation of the bedside-QST and the prediction rule that has
been developed to other treatments (mono- and multidisciplinary).
Study design
Longitudinal observational research in three hospitals. One cohort will be used
for the development of the prediction rule (VUMC), two cohorts will be used to
validate the prediction rule (UMCM and OLVG).
Patients will be asked to fill in questionnaires and to undergo simple
non-invasive measurements. Measurements will be performed at inclusion and
after 3, 6 and 12 months. Predictive models will be made for 3 and 6 months.
The best working model (concerning prediction and validity) will be
implemented. The 12-months measurement will be used to assess the long term
disease course for these NP patients.
Validated measurement instruments, applicable for the Dutch language, will be
used. Measurement values will be collected in a CRF or a diary.
Physical measurements / examinations are non-invasive. Signs of NP will be
measured according to the bedsite-QST with the Semmes Weinstein Monofilaments
test, the pressure algometer, the modified INCAT sensory scale (pinprick,
vibration, light touch, joint position sense). DNIC and summation will be used
to measure signs of sensory dysregulation. Measurements will be performed at
the most affected area of the most affected bodypart.
Study burden and risks
Burden on the patients:
4x 1 hour filling out questionnaires
4x 1 hour non-invasive simple physical tests at the VUmc
Risk associated with participation: none
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
A for neuropathic pain plausible anatomical distribution of the pain and/or a clinical record that indicates a lesion or disease of the central or peripheral nervous system.;At least 2 positive signs from a bedsite-QST-protocol;Able to speak Dutch adequately;Signed informed consent
Exclusion criteria
terminally ill patients
patients who don't speak Dutch adequately
no informed consent
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 | NL30114.029.09 |