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van CCT (UK)

Validation of the PDQ & DN4.

- candidate number10256
- NTR NumberNTR3030
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-aug-2011
- Secondary IDsABR 25343/Dossier NL25343.091.08 CCMO
- Public TitleValidation of the PDQ & DN4.
- Scientific TitlePainDETECT-Questionnaire and DN4: A Dutch validation study in patients with low back pain, neck shoulder pain or with a neuropathic pain syndrome.
- hypothesisThe aim of this study is to validate the Dutch versions of the PainDETECT questionnaire PD-Q and the ‘Douleur neuropathique en 4 questions’ (DN4) for use in primary and specialist medical care settings for patients with LBP and NSP and patients with neuropathic pain syndromes (NPS). The second objective is to assess the prevalence of neuropathy in patients with LBP and NSP in the Netherlands. Furthermore, this study aims to assess the general health status, mental health status, functioning, pain attribution and quality of life of patients with LBP, NSP and NPS.
- Healt Condition(s) or Problem(s) studiedNeuropathic pain , Validation, Questionnaires, Translation
- Inclusion criteria1. Men & Women;
2. At least 18 years old;
3. More than 3 months pain complaints of low back pain, neck shoulder pain radiating into respectively leg(s) or arm(s) or a neuropathic pain syndrome.
- Exclusion criteria1. Patients diagnosed with malignancy, compression fractures, ankylosing spondylitis or fibromyalgia;
2. Patients with painful syndromes of unknown origin or associated with diffuse pains, severe mental illness, chronic alcoholism or substance abuse;
3. Inability to fill in the questionnaire adequately;
4. Not capable to understand the Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 23-feb-2009
- planned closingdate1-jul-2013
- Target number of participants438
- InterventionsCross-sectional research design to study the psychometric quality of the PD-Q and the DN4 as compared to a gold standard (Diagnosis by two independant physiciqans), QST (20% of the study population) and the Grading System by Treede et al. (Neurology, 2008) with 2 weeks follow-up for test-retest reliability and 3 months follow-up for monitoring and prognosis.
- Primary outcome1. Outcome of the gold standard: The clinical examination serves as the goldstandard. Based on the grading system of Treede et al (2008), The gold standard is based on a standardized assessment performed by two independant working physicians;
2. Outcome of PDQ & DN4;
3. Outcome of Quantitative Sensory testing (QST) in 20% of the study population.
- Secondary outcome1. Medical comorbidity: Questionnaire with the most prevalent and relevant medical;
2. Mental health status: Hospital Anxiety Depression Scale (HADS) (Spinhoven et al. 1997);
3. Functioning: Disability Rating Index (DRI) (Salen et al. 1994);
4. Health related quality of life: Short form-36 (SF-36);
5. Pain Attribution Scale (Kraaimaat 200?). 6. prevalence of neuropathic pain in this patient groups.
- Timepoints1. Medical history, standardized gold standard, Questionnaires PDQ, DN4, DRI, HADS. SF-36, PAS + QST in 20% of the study population;
2. 2 weeks follow-up (test-retest reliability): PGIC, PDQ, DN4;
3. 3 months follow-up: PGIC, PDQ, DN4 (sensitivity for change, prognostic value).
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD18-aug-2011 - 12-sep-2012

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