Exploring pain modulation in shoulder arthroplasty patients
Endogenous Pain Modulation in Patients With Shoulder Arthroplasty for Osteoarthritis
Reinier Haga Orthopedisch Centrum · NCT05861960
This study is trying to see how pain responses change in patients with shoulder arthritis after they have surgery, and how their thoughts and coping methods might affect their pain after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Reinier Haga Orthopedisch Centrum (other) |
| Locations | 1 site (Zoetermeer) |
| Trial ID | NCT05861960 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the presence of central sensitization and abnormal conditioned pain modulation (CPM) responses in patients scheduled for total shoulder arthroplasty (TSA) due to osteoarthritis. It will assess whether these pain modulation measures change following surgery and explore the role of psychological factors and coping strategies in pain outcomes. The study focuses on a subgroup of patients to better understand the mechanisms behind persistent postoperative pain.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for primary total shoulder arthroplasty or reversed shoulder arthroplasty due to primary shoulder osteoarthritis.
Not a fit: Patients with chronic pain disorders other than osteoarthritis or those on certain medications like anti-depressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing shoulder arthroplasty.
How similar studies have performed: While studies have explored pain modulation in other types of arthroplasty, this specific focus on shoulder arthroplasty is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Zoetermeer
- Reinier Haga Orthopedic Center — Zoetermeer, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Brechtje Hesseling, MSc — Reinier Haga Orthopedisch Centrum
- Study coordinator: Brechtje Hesseling, MSc
- Email: onderzoek@rhoc.nl
- Phone: +31792065595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteo Arthritis Shoulders, Osteoarthritis Shoulder, Total shoulder arthroplasty, Osteoarthritis, Quantitative sensory testing, Conditioned pain modulation, Temporal summation