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Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty- The DOA study


- candidate number19304
- NTR NumberNTR4744
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-aug-2014
- Secondary IDsMETc nummer: 2014/087 
- Public TitleEffect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty- The DOA study
- Scientific TitleEffect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty- The DOA study
- ACRONYMDOA
- hypothesisPreoperative pain treatment by means of duloxetine will improve postoperative outcome after total hip or knee arthroplasty by reducing residual pain
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Total Hip Arthroplasty, Total knee arthroplasty, Residual pain
- Inclusion criteriaPrimary hip or knee osteoarthitis, age above 18 years and a neuropathic pain profile
- Exclusion criteriaSurgical 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-mei-2016
- Target number of participants118
- InterventionsPreoperative treatment with Duloxetine for a period of 10 weeks
- Primary outcomeDegree of pain relief 6 months after total hip or knee arthroplasty
- Secondary outcomeDegree of pain relief at other timepoints, specific neuropathic pain symptoms, functional improvement, physical activity, anxiety and depressive symptoms, quality of life and pain catastrophizing
- TimepointsBaseline, 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
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. M. Stevens
- CONTACT for SCIENTIFIC QUERIESDr. M. Stevens
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department Orthopaedic Surgery
- Funding
(Source(s) of Monetary or Material Support)
Reumafonds
- Publications
- Brief summaryTotal 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.
- Main changes (audit trail)
- RECORD15-aug-2014 - 10-okt-2014


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