Clinical trial NCT05861960: Endogenous Pain Modulation Study
Official title: Endogenous Pain Modulation in Patients With Shoulder Arthroplasty for Osteoarthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteo Arthritis Shoulders
Osteoarthritis Shoulder
Keywords: Total shoulder arthroplasty
Osteoarthritis
Quantitative sensory testing
Conditioned pain modulation
Temporal summation
Lead sponsor: Reinier Haga Orthopedisch Centrum
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are scheduled to undergo primary shoulder arthroplasty for shoulder osteoarthritis (OA) or rotator cuff tear arthropathy (CTA).

Brief summary: Rationale: 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.

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 population: Patients (age 18 years or older) who are scheduled to undergo shoulder arthroplasty for osteoarthritis, at the Reinier Haga Orthopaedic Centre.

Intervention (if applicable): Not applicable.

Main study parameters/endpoints: The main study parameters are CPM and TS values at baseline and at 3 and 6 months after surgery, as well as the absence/presence of allodynia at baseline and at 3 and 6 months after surgery.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden of participation will consist of completing questionnaires at baseline and at three and 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. The investigators do not expect any additional risks associated with participation. There is no direct benefit for the subjects.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)
timeFrame: Before surgery
measure: Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)
timeFrame: 3 months
measure: Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)
timeFrame: 6 months
measure: Percentage of patients with normal emporal summation (TS, TS value < 2 points)
timeFrame: Before surgery
measure: Percentage of patients with normal emporal summation (TS, TS value < 2 points)
timeFrame: 3 months
measure: Percentage of patients with normal emporal summation (TS, TS value < 2 points)
timeFrame: 6 months
Secondary outcomes:
measure: Mean pain score (NRS)
timeFrame: Before surgery, 3 months, 6 months
measure: Pain catastrophizing
timeFrame: Before surgery, 3 months, 6 months
measure: Coping strategies
timeFrame: Before surgery, 3 months, 6 months
Other outcomes:
measure: The number of complications
timeFrame: 3 months, 6 months
measure: Mean operating time
timeFrame: During surgery
measure: Optimal/suboptimal positioning of the prothesis
timeFrame: Directly postoperatively
Locations:
city: Zoetermeer
country: Netherlands
facility: Reinier Haga Orthopedic Center
Study officials:
affiliation: Reinier Haga Orthopedisch Centrum
name: Brechtje Hesseling, MSc
role: PRINCIPAL_INVESTIGATOR
References: