To identify somatosensory and nociceptive changes in the acute phase after stroke in relation to the development of shoulder pain.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline assessment consists of the assessment of pain complaints (current,
past) and assessment of neurological function. 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 outcome
x
Background summary
Shoulder 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.
Study objective
To identify somatosensory and nociceptive changes in the acute phase after
stroke in relation to the development of shoulder pain.
Study design
Prospective study. Patients are assessed from the acute phase (within 2 weeks)
after stroke up to 6 months post-stroke. Follow-up takes place at 3 and 6
months post-stroke.
Study burden and risks
The burden and risks of participation are low. Previous research in the acute
phase after stroke shows that baseline assessment of 45 minutes at the hospital
bed-side does not impose much burden upon the patient. Follow-up measurements
maximally take 1.5 hour per follow-up. All methods are non-invasive. The burden
of participation is low. There are no physical and mental risks of
participation. Participation does not interfere with treatment.
Postbus 217
7500 AE
Nederland
Postbus 217
7500 AE
Nederland
Listed location countries
Age
Inclusion criteria
Older than 18 years, legally competent, able to communicate, first-ever unilateral CVA (ischemic or hemorrhagic) of the middle cerebral artery (if possible confirmation by CT or MRI scan), somatosensory and motor loss during baseline measurement (0-2 weeks after stroke), sign informed consent
Exclusion criteria
Pregnancy, HIV/AIDS, any other brain disease (trauma, tumor, parkinson, multiple sclerosis), any peripheral neurological disease (amputation, neuropathy), pre-existent psychiatric disorders, pre-existent use of psychotropic substances or medication, chronic pain complaint (> 3 subsequent months) in the 6 months prior to stroke
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 | NL26665.044.09 |
| Other | voorlopig nummer: TCNR = 5556 |