|- candidate number||28224|
|- NTR Number||NTR6825|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-nov-2017|
|- Secondary IDs||17-117 (niet WMO plichtig) MEC ZWH|
|- Public Title||The Shoulder Diary|
|- Scientific Title||Higher expectations or fulfillment of expectations: which has the most impact on patient reported outcomes and what is the role of dispositional optimism and catastrophizing? A prospective cohort study (The Shoulder Diary)|
|- Healt Condition(s) or Problem(s) studied||Shoulder arthroplasty, Postoperative trajectory|
|- Inclusion criteria||• Age 18 years or older|
• Scheduled to undergo total shoulder arthroplasty (TSA), reversed shoulder arthroplasty (RSA) or hemiarthroplasty
• Able to provide written informed consent
|- Exclusion criteria||• Cognitive impairment|
• Difficulty with the Dutch language
• Receiving SA for acute fractures
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||24-apr-2018|
|- planned closingdate||2-mrt-2020|
|- Target number of participants||200|
|- Interventions||T0: 8 short questionnaires |
T1: The dairy with quentions about pain, shoulder function, quality of life and sleep.
T2: 9 short questionnaires
T3: 9 short questionnaires
The questionnaires are about expectations, pain, shoulder function, quality of life and complaints
|- Primary outcome||The main endpoints are postoperative pain, shoulder function, quality of life and patient satisfaction|
|- Secondary outcome||Not applicable|
|- Timepoints||T0: Pre-operatively|
T1: During the 8 weeks after surgery
T2: 6 months post-operatively
T3: 1 year post-operatively
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| N.M.C. Mathijssen|
|- CONTACT for SCIENTIFIC QUERIES|| N.M.C. Mathijssen|
|- Sponsor/Initiator ||Reinier de Graaf Groep, Department of Orthopaedics|
(Source(s) of Monetary or Material Support)
|Reinier de Graaf Gasthuis, Delft |
|- Brief summary||SUMMARY|
Background: To improve outcomes after shoulder arthroplasty (SA) it is essential to know which factors influence the outcome of SA. In total knee arthroplasty (TKA) and total hip arthroplasty (THA) research, the focus on the influence of psychological factors such as expectations, catastrophizing and optimism, as well as central sensitization (CS) and central pain modulation (CPM), increased in the last years. The effect of these constructs on the short-term and long-term outcomes is not completely clear: evidence regarding the effect of expectations on outcomes is inconsistent, while there is some evidence that catastrophizing and optimism influence or predict outcomes after surgery in general, and for TKA and THA in particular. For SA, very few studies have been performed on these topics. Therefore, it remains unclear whether these psychological constructs have similar effects in SA patients. Furthermore, it is still uncertain if an association between expectations and outcomes provides unique information on the role of expectations independent from catastrophizing, optimism, CS or CPM, or if these constructs interact with expectations.
Objective: The primary objectives of this study are to describe how patients experience the first eight weeks after shoulder arthroplasty with regard to pain, pain medication, shoulder function and quality of life, and to determine the direct effect of patients' expectations on postoperative pain, shoulder function, quality of life and satisfaction scores, controlled for catastrophizing and dispositional optimism. The secondary objective is to determine the direct effect of early postoperative pain on persistent postoperative pain at six months, while controlling for or taking into account modifying or mediating effects of factors that were found to have an effect on early postoperative pain itself.
Study design: A multicenter prospective observational cohort study.
Study population: Patients who are scheduled to undergo SA at the orthopedic department of participating hospitals or at the participating orthopedic clinics.
Primary study parameters/outcome: The main endpoints are postoperative pain, shoulder function, quality of life and patient satisfaction
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this study is solely an observational study in which patients complete questionnaires and will not undergo additional assessment compared with usual care, the burden of participation consists only of filling in sets of questionnaires at baseline, six months postoperatively and twelve months postoperatively. In addition, a daily diary will be kept for the first eight weeks, which will take approximately three minutes per day. We do not expect any risks associated with participation. There is no direct benefit for the participants.
|- Main changes (audit trail)||Studie niet-WMO plichtig.|
|- RECORD||17-nov-2017 - 2-mei-2018|