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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR3030 |
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Date of registration:
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18/08/2011 |
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Primary sponsor: |
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Public title:
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Validation of the PDQ & DN4.
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Scientific title:
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PainDETECT-Questionnaire and DN4: A Dutch validation study in patients with low back pain, neck shoulder pain or with a neuropathic pain syndrome. -
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Date of first enrolment:
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23/2/2009 |
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Target sample size:
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438 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3030 |
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Study type:
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observational |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: Parallel; Type: Single arm
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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H.
Timmerman |
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Address:
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Radboud University Nijmegen Medical centre
Department of Anesthesiology, Pain and Palliative Care
P.O.Box 9101
6500 HB
Nijmegen
The Netherlands |
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Telephone:
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+31 (0)6 53371015 |
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Email:
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h.timmerman@anes.umcn.nl |
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Affiliation:
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Name:
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H.
Timmerman |
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Address:
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Radboud University Nijmegen Medical centre
Department of Anesthesiology, Pain and Palliative Care
P.O.Box 9101
6500 HB
Nijmegen
The Netherlands |
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Telephone:
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+31 (0)6 53371015 |
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Email:
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h.timmerman@anes.umcn.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 criteria: 1. 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Neuropathic pain , Validation, Questionnaires, Translation
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Intervention(s)
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Cross-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.
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Primary Outcome(s)
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1. 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.
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Secondary Outcome(s)
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1. 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.
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Secondary ID(s)
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ABR 25343/Dossier NL25343.091.08
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Source(s) of Monetary Support
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Pfizer
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