|- candidate number||14958|
|- NTR Number||NTR4023|
|- ISRCTN||ISRCT wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-jun-2013|
|- Secondary IDs||P12.044 |
|- Public Title||Pain perception of the skin in healthy volunteers and neuropathic pain patients|
|- Scientific Title||Sensory testing of the skin using heat stimulation in healthy volunteers and neuropathic pain patients|
|- hypothesis||The aim of the study is:|
(1) observational, i.e., to assess and describe the responses of patients and volunteers to a variety of different stimulation paradigms;
(2) diagnostic, i.e., to assess whether specific tests are possibly diagnostic for specific pain syndromes;
(3) mechanistic, i.e., whether the results of the test may give us valuable information on the site of modulation (central or peripheral).
|- Healt Condition(s) or Problem(s) studied||chronic neuropathic pain, Fibromyalgia, Diabetic neuropathy, Sarcoidosis, Complex Regionaal Pain Syndrome (CRPS)|
|- Inclusion criteria||1. Patients diagnosed with CRPS-1, small-fiber neuropathy, central neuropathic pain or fibromyalgia, according to the guidelines of the IASP or other professional pain societies (eg., Netherlands Society of Anesthesiologists);|
2. A pain score of 5 or higher; (iii) age between 18 and 75 years; (iv) being able to give written informed consent.
Volunteer inclusion criteria. Healthy volunteers in the age range 18-75 years of either sex.
|- Exclusion criteria||1. Unable to give written informed consent;|
2. Medical disease such as renal, liver, cardiac, vascular (incl. hypertension) infectious disease;
3. Increased intracranial pressure;
7. A history of cerebro-vascular accident < 1 year;
9. Obesity (BMI > 30).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mrt-2013|
|- planned closingdate||1-jan-2014|
|- Target number of participants||60|
|- Interventions||Pain measurement. The Visual Analogue Scale (VAS) will be used to quantify pain
intensity in response to a noxious thermal stimulus. The thermal stimulus will be applied on the volar side of the forearm using the thermal probe (a 3 × 3 cm thermode) of the TSA-II NeuroSensory Analyzer (Medoc Ltd, Ramat Yishai, Israel).
We will apply different kind of pain stimuli to the arm:
1) A staircase increase in skin temperature is applied: 2 oC up, 1 oC down until
the eVAS score of 8 cm is reached.
(2) A contant increase in temperature will be applied, from 32 to 51 oC.
(3) A 3 min constant stimulus will be applied.
(4)Offset Analgesia. The temperature will be increased from baseline temperature to the individual’s test temperature (eVAS of 5 or 8). The test temperature will be constant for 5 s after which it was raised by 1°C for 5 seconds and next decreased by 1°C to the test temperature and kept constant for 20 seconds.
(5) Four 1 oC up/down tests separated by 10 s performed at an initial eVAS of 8
cm and 5 cm.
(6) An offset analgesia test followed by 1 oC step decreases at 10 s intervals.
(7) Variability testing. In order to get an indication of the effect of the position variability of the thermode on the skin we will measure the pain score to a fixed heat stimulus (a ramp from 32 to 49 oC) on 6 distinct spots on the volar side of the forearm.
|- Primary outcome||Response to different kind of pain stimuli|
|- Secondary outcome||N/A|
|- Timepoints||All the pain test will be performed on a single occasion on each subject participating in the study.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Albert Dahan|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Albert Dahan|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||In the current protocol we will perform a variety of sensory tests of the skin and measure
the pain response of patients and healthy volunteers. The variety of tests are based on the endogenous pain modulatory mechanism offset analgesia to better understand how healthy persons and patients suffering from chronic pain interpret and modulate pain.|
|- Main changes (audit trail)|
|- RECORD||5-jun-2013 - 15-jun-2013|