Endogenous Pain Modulation Study (EPM)

Endogenous Pain Modulation in Patients With Shoulder Arthroplasty for Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Shoulders; Osteoarthritis Shoulder

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Brechtje Hesseling, MSc; Phone Number: +31792065595; Email: onderzoek@rhoc.nl
• Study Contact Backup: Name: Roos Bazuin, BSc; Phone Number: +31792065595; Email: onderzoek@rhoc.nl

Study Locations

• Netherlands
  • Zoetermeer, Netherlands, 2725 NA
    • Recruiting
    • Reinier Haga Orthopedic Center
    • Contact: Nina Mathijssen; Phone Number: +31647208490; Email: N.Mathijssen@rhoc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean pain score (NRS)	Pain will be measured using the Numeric Rating Scal for pain (NRS). This is a scale on 0 (no pain) to 10 (worst pain).	Before surgery, 3 months, 6 months
Pain catastrophizing	The Pain Catastrophizing Scale (PCS) is a 13-item questionnaire that assesses catastrophizing about pain. The total score ranges from 0-52. A score of 30 and higher indicates a clinically relevant level of catastrophizing.	Before surgery, 3 months, 6 months
Coping strategies	The Brief COPE consists of 28 items, measuring 14 subscales. Each scale is measured by two items, with each item scoring form 1 to 4. Higher subscale scores indicate a higher use of that coping strategy.	Before surgery, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of complications	The complications after surgery	3 months, 6 months
Mean operating time	The operating time in mintues	During surgery
Optimal/suboptimal positioning of the prothesis	The positioning of the prothesis categorized in optimal and suboptimal based on the regular x-rays.	Directly postoperatively

Collaborators and Investigators

• Sponsor: Reinier Haga Orthopedisch Centrum
• Investigators: Principal Investigator: Brechtje Hesseling, MSc, Reinier Haga Orthopedisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; Quantitative sensory testing; Total shoulder arthroplasty; Conditioned pain modulation; Temporal summation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2019-005-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No