|- candidate number||8449|
|- NTR Number||NTR2512|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-sep-2010|
|- Secondary IDs||P10-33 METC Medisch Spectrum Twente|
|- Public Title||Relationship between self-reported disability, performance based disability and psychological factors in patients with complaints of whiplash. |
|- Scientific Title||Relationship between self-reported disability, performance based disability and psychological factors in patients with complaints of whiplash. |
|- hypothesis||In patients with WAD the strength of the relationship between self reported disability and work capacity is weak to moderate (correlation coefficient between r=0.25 and r=0.75).
Work capacity and performance can be predicted with the help of psychosocial, psychological and demographic factors.|
|- Healt Condition(s) or Problem(s) studied||Psychologic factors, Whiplash, Functional capacity evaluation, Disability|
|- Inclusion criteria||1. A WAD I-II diagnosis by a doctor;|
2. Complaints six months or longer;
3. Age between 18 and 65 years;
4. Patients are with sick leave.
|- Exclusion criteria||1. Co-morbidity with severe negative consequences for functioning;|
2. A diagnosis of psychiatric illness;
3. Insufficient knowledge of the Dutch language;
4. Severe neck problems before the trauma like arthrosis or hernias.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2010|
|- planned closingdate||30-sep-2011|
|- Target number of participants||50|
|- Primary outcome||1. The “Neck Disability Index” (self-reported disability);|
2. The Neck specific version of the Functional Capacity Evaluation for neck complaints (performance based disability).
|- Secondary outcome||1. The triaxial accelerometer to measure the actual performance;|
2. The TAMPA to measure fear of movement;
3. The 4DSQ to measure depression, anxiety and distress;
4. The UCL to measure coping styles;
5. The CIS20R to measure fatigue;
6. The Pain Self Efficacy Questionnaire to measure self efficacy;
7. The RAND to measure quality of life;
8. The VAS to measure the level of pain;
9. The demographic information consist of gender, age, height, weight, marital status, duration of complaints, present medication, education level, working status and claim status.
|- Timepoints||All patients undergo the measurements one time. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc. S. Meer, van der|
|- CONTACT for SCIENTIFIC QUERIES||MSc. S. Meer, van der|
|- Sponsor/Initiator ||Condite, Advies bij ziekteverzuim|
(Source(s) of Monetary or Material Support)
|Stichting Achmea Gezondheidszorg (SAG)|
|- Brief summary||Rationale: |
Sick leave in patients with chronic whiplash associated disorders (WAD) is an important problem for society. 15-30% Of the patients continue to experience serious symptoms after the first six months. Pain related disability is a complex multidimensional construct, influence by biological, psychological and social factors. Valid measurement of disability is challenging. Self reported disability and performance based disability are assumed to be related which each other but distinct. However, this has not been tested in patients with WAD.
To investigate the relationship between self-reported disability, performance based disability and psychological factors in patients with WAD.
Cross-sectional observational study.
Fifty patients with complaints of chronic whiplash (WAD I-II).
Main study parameters/endpoints:
The “Neck Disability Index” (self-reported disability) and the Neck Specific version of the Functional Capacity Evaluation for neck complaints (performance based disability).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risk of the study is negligible. All test are considered safe for the patients and with a low burden.
|- Main changes (audit trail)|
|- RECORD||15-sep-2010 - 26-sep-2010|