No registrations found.
ID
Source
Health condition
osteoarthritis; hip; knee; chronic pain; duloxetine; general practice; artrose; heup; knie; chronische pijn; huisarts
Sponsors and support
ZonMw
Intervention
Outcome measures
Primary outcome
Pain at 3 months measured with the WOMAC pain subscale
Secondary outcome
Pain at 1 year (WOMAC pain subscale), Disability (WOMAC function subscale)
Adverse reactions
Quality of life with the EQ-5D
Compliance to treatment (Brief Medication Questionnaire)
Patients’ satisfaction
OARSI-OMERACT responder criteria
Costs; including direct medical and patient costs (iMCQ) and productivity costs (iPCQ).
Background summary
Introduction Osteoarthritis (OA) is a highly prevalent painful condition of the musculoskeletal system. The effectiveness of current analgesic options has proven to be limited and improved analgesic treatment is needed.
Several randomised placebo-controlled trials have now demonstrated the efficacy of duloxetine, an antidepressant with a centrally acting effect, in the treatment of OA pain. The aim of the current study is to investigate if duloxetine is effective and cost-effective as a third-choice analgesic added to usual care for treating chronic pain compared with usual care alone in general practice.
Methods and analysis A pragmatic open, cluster randomised trial is conducted. Patients with pain due to hip or knee OA on most days of the past 3months with insufficient benefit of non-steroidal anti-inflammatory drugs or contraindications or intolerable side effects are included. General practices are randomised to either (1) duloxetine and usual care or (2) usual care only. Primary outcome is pain at 3 months measured on the Western
Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes at 3 months and 1 year are pain (WOMAC, at 1 year), function (WOMAC), adverse reactions, quality of life and modification of the response to treatment by the presence of centrally sensitised pain (modified PainDETECT). At 1 year, medical and productivity costs will be assessed. Analyses will be performed following the intention-to-treat principle taking the cluster design into account.
Ethics and dissemination The study is approved by the local Medical Ethics Committee (2015–293). Results will be published in a scientific peer-reviewed journal and will be communicated at conferences.
Trial registration number Dutch Trial Registry(ntr4798)
Study objective
Duloxetine is effective as third choice pain medication for treating chronic pain in osteoarthritis patients.
Study design
Baseline, 3, 6, 9 and 12 months
Intervention
Participating general practices will be randomized to either: 1) prescribe duloxetine as third choice pain medication in combination with usual care; or 2) provide usual care only (no antidepressants for pain
medication).
Postbus 2040
D. Schiphof
Rotterdam 3000 CA
The Netherlands
0031107043623
d.schiphof@erasmusmc.nl
Postbus 2040
D. Schiphof
Rotterdam 3000 CA
The Netherlands
0031107043623
d.schiphof@erasmusmc.nl
Inclusion criteria
1) having hip or knee OA based on the clinical ACR criteria, and 2) having chronic pain (most days of the last three months) in hip or knee, and 3) either: (i) a contra-indication for NSAIDs; (ii) adverse reactions of NSAIDs; or (iii) insufficient benefit of NSAIDs.
Exclusion criteria
1) on waiting list for hip/knee replacement, and 2) use of antidepressants, 3) contra-indication of duloxetine (use of Monoamine Oxidase Inhibitors, having uncontrolled narrow-angle glaucoma, in combination with (other) central nervous system acting drugs, in combination with thioridazine, hypersensitivity to duloxetine)
Design
Recruitment
IPD sharing statement
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 | NL4655 |
| NTR-old | NTR4798 |
| Other | ZonMw : 80-83600-98-3143 |
Summary results
van den Driest JJ, Schiphof D, Koffeman AR et al. No added value of duloxetine in patients with chronic pain due to hip or knee osteoarthritis: a cluster-randomized trial. Arthritis Rehumatol 2022; Jan 6. doi: 10.1002/art.42040