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Clinical Trial NCT05861960 (EPM) for Osteo Arthritis Shoulders, Osteoarthritis Shoulder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Endogenous Pain Modulation Study (EPM) 25 Observational
Clinical Trial NCT05861960 (EPM) is an observational study for Osteo Arthritis Shoulders, Osteoarthritis Shoulder that is recruiting. It started on 4 March 2024 with plans to enroll 25 participants. Led by Reinier Haga Orthopedisch Centrum, it is expected to complete by 1 August 2025. The latest data from ClinicalTrials.gov was last updated on 6 March 2024.
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...Show More
Official Title
Endogenous Pain Modulation in Patients With Shoulder Arthroplasty for Osteoarthritis
Conditions
Osteo Arthritis ShouldersOsteoarthritis ShoulderOther Study IDs
- EPM
- 2019-005-M
NCT ID Number
Start Date (Actual)
2024-03-04
Last Update Posted
2024-03-06
Completion Date (Estimated)
2025-08
Enrollment (Estimated)
25
Study Type
Observational
Status
Recruiting
Keywords
Total shoulder arthroplasty
Osteoarthritis
Quantitative sensory testing
Conditioned pain modulation
Temporal summation
Osteoarthritis
Quantitative sensory testing
Conditioned pain modulation
Temporal summation
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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)
Reinier Haga Orthopedisch CentrumStudy Central Contact
Contact: Brechtje Hesseling, MSc, +31792065595, [email protected]
Contact: Roos Bazuin, BSc, +31792065595, [email protected]
1 Study Locations in 1 Countries
Reinier Haga Orthopedic Center, Zoetermeer, 2725 NA, Netherlands
Nina Mathijssen, Contact, +31647208490, [email protected]
Recruiting