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Remote ischemic preconditioning and pain


- candidate number18021
- NTR NumberNTR4625
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2014
- Secondary IDsNL47776.091.14 CMO regio Arnhem-Nijmegen (Nijmegen)
- Public TitleRemote ischemic preconditioning and pain
- Scientific TitlePilot study to investigate the effect of remote ischemic preconditioning on pain measured using Quantitative Sensory Testing
- ACRONYM
- hypothesisPain is an unpleasant experience with a multifactorial aetiology. It is feared by most people undergoing surgery. In the postoperative period pain is controlled using many different drugs. All of these drugs have their own adverse events. Ideally pain is controlled by a non-invasive method whereby no adverse events occur. A possible non-invasive method to reduce pain is remote ischaemic preconditioning (RIPC). Current practice could change on a large scale if the link between RIPC and lower pain scores can be confirmed. If we are able to demonstrate this, in future less analgesics will be needed. Complications and adverse events of analgesics can be overcome that way.
- Healt Condition(s) or Problem(s) studiedPain, Remote ischemic preconditioning
- Inclusion criteriaHealthy
18 65 years old
- Exclusion criteria Cognitive malfunction
Not being able to abstain from analgesics 1 day before examination or taking analgesics regularly
Body mass index (BMI) of > 35 kg/m2
Post-traumatic lengthy hand reconstruction on both upper extremities
Severe crushing injuries on both upper extremities
Skin grafts on both upper extremities
Pregnancy or nursing
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 2-jun-2014
- planned closingdate30-jun-2015
- Target number of participants12
- InterventionsAn observational study of a double session per subject; QST will be measured before application of the pneumatic tourniquet and after 10 minutes of pneumatic tourniquet pressure. In one session the tourniquet will be inflated 50 mmHg above volunteers systolic blood pressure. In the other session the tourniquet will be inflated at 20 mmHg. The sequence of the sessions will be randomized with drawing envelopes.
- Primary outcomeDoes ischemic preconditioning alters pain perception in healthy individuals measured with QST?
- Secondary outcome Has ischemic preconditioning a different effect on pressure pain thresholds and electrical pain thresholds measured with pressure pain thresholds (PPT), electrical pain detection threshold test (EPT) and cold pain thresholds (CPT)?
How painful are 10 minutes of ischemic preconditioning using a pneumatic tourniquet 50 mmHg above volunteers SBP measured with VAS?
Is there a correlation between the score of an individual on the Pain Catastrophe Scale and pain thresholds?
- TimepointsQST measurements containt:
- Cold pain thresholds will be measured using the ice water bucket.
- Pressure Pain Thresholds (PPT) are tested by use of a pressure algometer. PPT is measured on the left and right body side once at the thenar (middle part).
- Electric pain thresholds (EPT) are tested by use of the QST-3 device (JNI Biomedical ApS, Klarup, Denmark) on the left and right body side. Measurement location is the musculus rectus femoris (20 cm above patella).

The Pain Catastophe Scale (PCS) can be completed and scored in less than 5 minutes. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thought or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time.

Volunteers are asked to fill in a standardized questionnaire for depression and anxiety. The questionnaire used is the DASS - Depression Anxiety Stress Scales
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. V.D. Linssen
- CONTACT for SCIENTIFIC QUERIESDrs. V.D. Linssen
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- Publications
- Brief summaryBackground of the study:
Pain is an unpleasant experience with a multifactorial aetiology. It is feared by most people undergoing surgery. In the postoperative period pain is controlled using many different drugs. All of these drugs have their own adverse events. Ideally pain is controlled by a non-invasive method whereby no adverse events occur. A possible non-invasive method to reduce pain is remote ischaemic preconditioning (RIPC). Current practice could change on a large scale if the link between RIPC and lower pain scores can be confirmed. If we are able to demonstrate this, in future less analgesics will be needed. Complications and adverse events of analgesics can be overcome that way.
Objective of the study:
The effect of 10 minutes of ischemic preconditioning produced with a pneumatic tourniquet on pain perception.
Study design:
An observational study of a double session per subject; QST will be measured before application of the pneumatic tourniquet and after 10 minutes of pneumatic tourniquet pressure
Study population:
Healthy human volunteers, 18-65 years old
Primary study parameters/outcome of the study: Does ischemic preconditioning alters pain perception in healthy individuals measured with QST?
Secundary study parameters/outcome of the study (if applicable):
Has ischemic preconditioning a different effect on pressure pain thresholds and electrical pain thresholds measured with pressure pain thresholds (PPT), electrical pain detection threshold test (EPT) and cold pain thresholds (CPT)?
How painful are 10 minutes of ischemic preconditioning using a pneumatic tourniquet 50 mmHg above volunteers SBP measured with VAS?
Is there a correlation between the score of an individual on the Pain Catastrophe Scale and pain thresholds?
Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):
Participation involves two sessions of at most six hours, including Quantitative Sensory Testing, Depression Anxiety Stress Scales and Pain Catastrophe Scale, as well as application of 10 minutes of pneumatic tourniquet pressure 50 mmHg above the volunteers systolic blood pressure. The anticipated risks for the study subjects are well defined and of short duration. Therefore, participation in this study does not represent an undue risk for subjects.
- Main changes (audit trail)
- RECORD3-jun-2014 - 1-jul-2014


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