search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Perisurgical observation of nociceptive thresholds during total knee arthroplasty for association with persisting postsurgical pain: an explorative study


- candidate number21576
- NTR NumberNTR4981
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2015
- Secondary IDsNL47455.091.14 2014-235 CMO Regio Arnhem-Nijmegen
- Public TitlePerisurgical observation of nociceptive thresholds during total knee arthroplasty for association with persisting postsurgical pain: an explorative study
- Scientific TitlePerisurgical observation of nociceptive thresholds during total knee arthroplasty for association with persisting postsurgical pain: an explorative study
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedTotal knee arthroplasty, Chronic pain
- Inclusion criteriaPatients scheduled for total knee arthroplasty.
- Exclusion criteria- Patientís refusal
- Preexisting neurological or psychiatric illnesses
- Chronic pain syndromes
- Alcohol or drug abuse
- Suspected possibility of delirium
- Difficulties in communication
- Rheumatoid arthritis
- Revision knee surgery or participation in another study
- Presurgicaloperative ASA score >3
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-feb-2015
- planned closingdate30-jun-2017
- Target number of participants40
- InterventionsNot applicable
- Primary outcome- Persistent postsurgical pain (PPSP)
- eQST
o Electrical pain threshold (ePT) [mA]
o Electrical pain tolerance threshold (ePTT) [mA]
- Nociceptive Perception thresholds (NPT)
o Stimulus amplitude [mA]
o Responses to stimuli (perceived/not perceived)
o Stimulation time [s]
- Secondary outcome- Pain intensity (NRS)
- McMaster Universities Osteoarthritis Index (WOMAC)
o Pain scale
o Stiffness scale
o Functional scale
- Knee Society Score (KSS)
o Functional scale
- TimepointsPreoperative: baseline measurement at -35 to -7 days
Postoperative: days 2, 42, 84, 168, and 365
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES R.J. Doll
- CONTACT for SCIENTIFIC QUERIES R.J. Doll
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
STW/NWO
- PublicationsN/A
- Brief summaryBackground of the study: Total knee arthroplasty (TKA) often produce severe persistent postsurgical pain (PPSP), and in some cases, chronic pain. While the acute pain postpones the early recovery, the chronic pain seriously restricts an individualís quality of life, and also increases costs of global health care and absenteeism at work. Central sensitization plays a major role in the development of PPSP. Sensitization is characterized by generalized hyperalgesia and can be detected by means of a decrease in (electrical) pain threshold. Recently, a pilot study showed that presurgical electrical pain tolerance thresholds (ePTT) have predictive value for PPSP in abdominal surgery patients. Other pilot studies suggest that, in addition to ePTTs, electrical nociceptive perception thresholds (eNPTs), when tracked over a short period of time (e.g. 25 minutes) can be expected to be able to observe changes in peripheral and/or central mechanisms in more detail than regular EPTs. Results after TKA show similar persisting pain incidences as after abdominal surgery. Therefore, these patients are a suitable population to study the generalizability of the results found in previous studies. Objective of the study: The main objective of this study is to investigate the predictability of persisting postsurgical pain (PPSP) after TKA using electrical quantitative sensory testing (eQST) and nociceptive perception thresholds (NPT) in combination with a presurgical conditioning pain modulation (CPM) paradigm. The secondary objectives of this study are to investigate (1) the effect of TKA on stimulus specific changes in NPT, and (2) the correlation between eQST versus NPT and PPSP. Study design: Monocentre prospective observational study
- Main changes (audit trail)
- RECORD14-jan-2015 - 17-mrt-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl