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van CCT (UK)

van CCT (UK)

Pain perception of the skin in healthy volunteers and neuropathic pain patients

- candidate number14958
- NTR NumberNTR4023
- ISRCTNISRCT wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jun-2013
- Secondary IDsP12.044 
- Public TitlePain perception of the skin in healthy volunteers and neuropathic pain patients
- Scientific TitleSensory testing of the skin using heat stimulation in healthy volunteers and neuropathic pain patients
- hypothesisThe 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) studiedchronic neuropathic pain, Fibromyalgia, Diabetic neuropathy, Sarcoidosis, Complex Regionaal Pain Syndrome (CRPS)
- Inclusion criteria1. 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 criteria1. Unable to give written informed consent;
2. Medical disease such as renal, liver, cardiac, vascular (incl. hypertension) infectious disease;
3. Increased intracranial pressure;
4. Epilepsy;
5. Psychosis;
6. Glaucoma;
7. A history of cerebro-vascular accident < 1 year;
8. Pregnancy;
9. Obesity (BMI > 30).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2013
- planned closingdate1-jan-2014
- Target number of participants60
- InterventionsPain 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 outcomeResponse to different kind of pain stimuli
- Secondary outcomeN/A
- TimepointsAll the pain test will be performed on a single occasion on each subject participating in the study.
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryIn 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)
- RECORD5-jun-2013 - 15-jun-2013

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