NCT05861960

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

April 21, 2023

Last Update Submit

March 4, 2024

Conditions

Osteo Arthritis ShouldersOsteoarthritis Shoulder

Keywords

Total shoulder arthroplastyOsteoarthritisQuantitative sensory testingConditioned pain modulationTemporal summation

Outcome Measures

Primary Outcomes (6)

  • Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)

    The subjects will score pain perception during the stimuli using the electronic visual analogue scoring (eVAS) system. The eVAS is scored on a scale of 0 (no pain) to 10 (worst pain).

    Before surgery

  • Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)

    The subjects will score pain perception during the stimuli using the electronic visual analogue scoring (eVAS) system. The eVAS is scored on a scale of 0 (no pain) to 10 (worst pain).

    3 months

  • Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)

    The subjects will score pain perception during the stimuli using the electronic visual analogue scoring (eVAS) system. The eVAS is scored on a scale of 0 (no pain) to 10 (worst pain).

    6 months

  • Percentage of patients with normal emporal summation (TS, TS value < 2 points)

    Subjects will verbally rate their pain during the test using the numeric rating scale (NRS). This is a scale on 0 (no pain) to 10 (worst pain).

    Before surgery

  • Percentage of patients with normal emporal summation (TS, TS value < 2 points)

    Subjects will verbally rate their pain during the test using the numeric rating scale (NRS). This is a scale on 0 (no pain) to 10 (worst pain).

    3 months

  • Percentage of patients with normal emporal summation (TS, TS value < 2 points)

    Subjects will verbally rate their pain during the test using the numeric rating scale (NRS). This is a scale on 0 (no pain) to 10 (worst pain).

    6 months

Secondary Outcomes (3)

  • Mean pain score (NRS)

    Before surgery, 3 months, 6 months

  • Pain catastrophizing

    Before surgery, 3 months, 6 months

  • Coping strategies

    Before surgery, 3 months, 6 months

Other Outcomes (3)

  • The number of complications

    3 months, 6 months

  • Mean operating time

    During surgery

  • Optimal/suboptimal positioning of the prothesis

    Directly postoperatively

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who are scheduled to undergo primary shoulder arthroplasty for shoulder osteoarthritis (OA) or rotator cuff tear arthropathy (CTA).

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reinier Haga Orthopedic Center

Zoetermeer, 2725 NA, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Brechtje Hesseling, MSc

    Reinier Haga Orthopedisch Centrum

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brechtje Hesseling, MSc

CONTACT

+31792065595onderzoek@rhoc.nl

Roos Bazuin, BSc

CONTACT

+31792065595onderzoek@rhoc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2023

First Posted

May 17, 2023

Study Start

March 4, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

NL(1)