No registrations found.
ID
Source
Brief title
Health condition
osteoarthritis; central sensitization; peripheral sensitization; residual pain
Dutch: artrose; centrale sensitisatie; perifere sensitisatie; residuele pijn
Sponsors and support
Intervention
Outcome measures
Primary outcome
Degree of pain relief 6 months after total hip or knee arthroplasty
Secondary outcome
Degree of pain relief at other timepoints, specific neuropathic pain symptoms, functional improvement, physical activity, anxiety and depressive symptoms, quality of life and pain catastrophizing
Background summary
Total Joint Replacement is considered a successful treatment for end stage osteoarthritis. However, residual pain after Total Joint Replacement forms a substantial problem affecting up to 23% - 34% of patients after Total Hip or Knee Replacement (THR/TKR). There is a growing amount of evidence in literature that pain in osteoarthritis can be amplified by sensitization of the central nervous system. Moreover, preoperative characteristics of central sensitization are associated with poorer postoperative outcomes, like residual pain. Therefore preoperative treatment of central sensitization may reduce residual pain after THR/TKR. Duloxetine, a serotonin and norepinephrine reuptake inhibitor, has proven to be effective in several chronic pain syndromes in which central sensitization is believed to be involved. This trial assesses the postoperative effects on pain and function of a preoperative duloxetine treatment to a group of patients scheduled for THR/TKR and who likely suffer from a degree of central sensitization, compared to usual care.
Study objective
Preoperative pain treatment by means of duloxetine will improve postoperative outcome after total hip or knee arthroplasty by reducing residual pain
Study design
Baseline, after two weeks, 8 weeks and 10 weeks of duloxetine treatment, 1 day before surgery, 48 hours after surgery, 6 weeks, 6 months and 12 months after surgery
Intervention
Preoperative treatment with Duloxetine for a period of 10 weeks
Department of Orthopaedic Surgery
P.O. Box 30.001
M. Stevens
Groningen 9700 RB
The Netherlands
+31 (0)50 3613271
m.stevens@umcg.nl
Department of Orthopaedic Surgery
P.O. Box 30.001
M. Stevens
Groningen 9700 RB
The Netherlands
+31 (0)50 3613271
m.stevens@umcg.nl
Inclusion criteria
Primary hip or knee osteoarthitis, age above 18 years and a neuropathic pain profile
Exclusion criteria
Surgical hip or knee procedure in previous year, hip or knee arthroscopy or injection past 3 months, unstable other medical condition, cognitive of neurological disorder or peripheral nerve injury, previous exposure to duloxetine
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4576 |
NTR-old | NTR4744 |
Other | : METc nummer: 2014/087 |