The primary objective is to explore whether central sensitization and/or abnormal CPM responses are present in (a subgroup of) patients who will receive shoulder arthroplasty for osteoarthritis, and whether shoulder arthroplasty produces change in…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
- No intervention
N.a.
Outcome measures
Primary outcome
<p>The main study parameters are CPM and TS values at baseline and at 3 and 6<br />
months after surgery, as well as the absence/presence of allodynia at baseline<br />
and at 3 and 6 months after surgery.</p>
Secondary outcome
<p>Secondary outcomes are painscores, pain catastrophizing and coping strategies<br />
at baseline and at 3 and 6 months after surgery.</p>
Background summary
Although most patients experience significant pain relief after total shoulder
arthroplasty (TSA), pain persists for some patients even after surgery. The
endogenous pain system may be involved in persisting postoperative pain in
total knee arthroplasty (TKA) and total hip arthroplasty (THA) patients, but
this has never been studies for TSA patients. Furthermore, psychological
factors and coping strategies may also be of interest but have not yet been
extensively studied in TSA patients.
Study objective
The primary objective is to explore whether central sensitization and/or
abnormal CPM responses are present in (a subgroup of) patients who will receive
shoulder arthroplasty for osteoarthritis, and whether shoulder arthroplasty
produces change in these measures of the endogenous pain modulatory system.
The secondary objective, in case patients with altered endogenous pain
modulation are found, is to explore if change in pain over time, psychological
factors and coping strategies differ between patients with and without altered
pain modulation.
Study design
An exploratory prospective observational cohort study.
Study burden and risks
The burden of participation will consist of completing questionnaires at
baseline and every month for six months after surgery. In addition, subjects
will undergo psychophysical testing at 3 moments, which can lead to redness or
a burning sensation of the skin during the first 24 hours after testing. We do
not expect any additional risks associated with participation. There is no
direct benefit for the participants.
B. Hesseling
Toneellaan 2
Zoetermeer 2725 NA
Netherlands
079-2065595
onderzoek@rhoc.nl
B. Hesseling
Toneellaan 2
Zoetermeer 2725 NA
Netherlands
079-2065595
onderzoek@rhoc.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- Age >= 18 yrs
- Scheduled to undergo primary total shoulder arthroplasty (TSA) or reversed
shoulder arthroplasty (RSA) for primary shoulder osteoarthritis or cuff tear
arthropathy
- American Society of Anesthesiologists score 1, 2 or 3
- Able to provide written informed consent
Exclusion criteria
- Regular use of anti-depressants or anti-epileptics for any purpose, including
SNRIs and gabapentinoids
- The presence of any chronic pain disorder other than osteoarthritis
- Osteoarthritis in joints other than the affected shoulder, for which
arthroplasty is/will be planned in the near future
• Difficulty with or inability to perform psychophysical testing (eg. in case
of cognitive or psychiatric disorders)
- Difficulty with or inability to communicate with the investigators (eg.
difficulty with the Dutch language, cognitive/memory disorders)
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT05861960 |
| CCMO | NL81143.058.22 |
| Research portal | NL-007484 |