No registrations found.
ID
Source
Health condition
Total knee arthroplasty, persisting pain, chronic pain
Sponsors and support
Intervention
Outcome measures
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
Background summary
Background 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 individual’s 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
Study design
Preoperative: baseline measurement at -35 to -7 days
Postoperative: days 2, 42, 84, 168, and 365
Intervention
Not applicable
Inclusion criteria
Patients scheduled for total knee arthroplasty.
Exclusion criteria
- Patient’s 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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4710 |
NTR-old | NTR4981 |
CCMO | NL47455.091.14 |
OMON | NL-OMON40450 |