Evidence map›Paper›PMID 26932142›Full record

Trial reportBMJ open2016

Duloxetine in OsteoArthritis (DOA) study: study protocol of a pragmatic open-label randomised controlled trial assessing the effect of preoperative pain treatment on postoperative outcome after total hip or knee arthroplasty.

T Blikman, W Rienstra, T M van Raaij, A J ten Hagen, B Dijkstra, W P Zijlstra, S K Bulstra, I van den Akker-Scheek, M Stevens

Abstract readMulticenter StudyPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

T BlikmanDepartment of Orthopaedics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
W RienstraDepartment of Orthopaedics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
T M van RaaijDepartment of Orthopaedics, Martini Hospital Groningen, Groningen, The Netherlands.
A J ten HagenDepartment of Anaesthesiology, Martini Hospital Groningen, Groningen, The Netherlands.
B DijkstraDepartment of Orthopaedics, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
W P ZijlstraDepartment of Orthopaedics, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
S K BulstraDepartment of Orthopaedics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
I van den Akker-ScheekDepartment of Orthopaedics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
M StevensDepartment of Orthopaedics, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionResidual pain is a major factor in patient dissatisfaction following total hip arthroplasty or total knee arthroplasty (THA/TKA). The proportion of patients with unfavourable long-term residual pain is high, ranging from 7% to 34%. There are studies indicating that a preoperative degree of central sensitisation (CS) is associated with poorer postoperative outcomes and residual pain. It is thus hypothesised that preoperative treatment of CS could enhance postoperative outcomes. Duloxetine has been shown to be effective for several chronic pain syndromes, including knee osteoarthritis (OA), in which CS is most likely one of the underlying pain mechanisms. This study aims to evaluate the postoperative effects of preoperative screening and targeted duloxetine treatment of CS on residual pain compared with care-as-usual. METHODS AND ANALYSIS: This multicentre, pragmatic, prospective, open-label, randomised controlled trial includes patients with idiopathic hip/knee OA who are on a waiting list for primary THA/TKA. Patients at risk for CS will be randomly allocated to the preoperative duloxetine treatment programme group or the care-as-usual control group. The primary end point is the degree of postoperative pain 6 months after THA/TKA. Secondary end points at multiple time points up to 12 months postoperatively are: pain, neuropathic pain-like symptoms, (pain) sensitisation, pain catastrophising, joint-associated problems, physical activity, health-related quality of life, depressive and anxiety symptoms, and perceived improvement. Data will be analysed on an intention-to-treat basis. ETHICS AND DISSEMINATION: The study is approved by the local Medical Ethics Committee (METc 2014/087) and will be conducted according to the principles of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard (GCP), and in compliance with the Medical Research Involving Human Subjects Act (WMO). TRIAL REGISTRATION NUMBER: 2013-004313-41; Pre-results.

Indexed as

Research DesignAnalgesicsArthroplasty, Replacement, HipArthroplasty, Replacement, KneeDuloxetine HydrochlorideHumansOsteoarthritis, HipOsteoarthritis, KneePain ManagementPostoperative ComplicationsPostoperative PainPostoperative PeriodPreoperative CareProspective StudiesQuality of LifeAnalgesicsDuloxetine HydrochloridePAIN MANAGEMENTREHABILITATION MEDICINE

Identifiers

PMID26932142
PMCPMC4785324

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.