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The development of shoulder pain after stroke.


- candidate number5556
- NTR NumberNTR1746
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2009
- Secondary IDsP09-05 MEC Twente
- Public TitleThe development of shoulder pain after stroke.
- Scientific TitleThe relation between somatosensation, nociception and the development of shoulder pain after stroke.
- ACRONYMThe development of shoulder pain after stroke
- hypothesisShoulder pain is related to somatosensory and nociceptive changes in the acute phase after stroke. These changes may indicate the involvement of specific mechanisms (nociceptive, neuropathic) of post-stroke shoulder pain. Changes may either precede or follow the development of shoulder pain.
- Healt Condition(s) or Problem(s) studiedStroke, Post-stroke shoulder pain
- Inclusion criteria1. Older than 18 years;
2. Legally competent;
3. Able to communicate;
4. First-ever unilateral CVA (ischemic or hemorrhagic) of the middle cerebral artery (if possible confirmation by CT or MRI scan);
5. Somatosensory and motor loss during baseline measurement (0-2 weeks after stroke);
6. Sign informed consent.
- Exclusion criteria1. Pregnancy;
2. HIV/AIDS;
3. Any other brain disease (trauma, tumor, parkinson, multiple sclerosis);
4. Any peripheral neurological disease (amputation, neuropathy);
5. Pre-existent psychiatric disorders;
6. Pre-existent use of psychotropic substances or medication;
7. Chronic pain complaint (> 3 subsequent months) in the 6 months prior to stroke.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2009
- planned closingdate31-mei-2010
- Target number of participants100
- InterventionsN/A
- Primary outcomeBaseline assessment consists of a questionnaire that assesses pain complaints (current, past), clinical neurological tests (touch, temperature, sharpness) and tests for motor function. Moreover, general neurologic status and emotional status are assessed. Follow-up measurements consist of the assessment of pain complaints (quality, quantity) and the assessment of somatosensory and nociceptive changes using quantitative sensory testing and cold pressor testing.
- Secondary outcome1. Motor function;
2. Depression.
- Timepoints1. Baseline: 0-2 weeks post-stroke;
2. Follow up 1: 3 months post-stroke;
3. Follow up 2: 6 months post-stroke.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M. Roosink
- CONTACT for SCIENTIFIC QUERIESDrs. M. Roosink
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
University of Twente, Roessingh Rehabilitation Center
- PublicationsN/A
- Brief summaryShoulder pain is a common complication after stroke and in some cases difficult to treat. Better prevention in the acute stroke phase and appropriate treatment in of shoulder pain may be accomplished when more is known about the neurophysiological mechanisms underlying the development and chronification of shoulder pain after stroke. The objective of the study is to identify somatosensory and nociceptive changes in the acute phase after stroke in relation to the development of shoulder pain.
- Main changes (audit trail)
- RECORD6-apr-2009 - 23-sep-2009


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