Endogenous Pain Modulation Study

Osteoarthritis Shoulder Clinical Trial

— EPM  

Official title:

Endogenous Pain Modulation in Patients With Shoulder Arthroplasty for Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05861960
• Other study ID #: 2019-005-M
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Reinier Haga Orthopedisch Centrum
• Contact: Brechtje Hesseling, MSc
• Phone: +31792065595
• Email: onderzoek[@]rhoc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteo Arthritis Shoulders
• Osteoarthritis
• Osteoarthritis Shoulder

Locations

Country	Name	City	State
Netherlands	Reinier Haga Orthopedic Center	Zoetermeer

Sponsors (1)

Lead Sponsor	Collaborator
Reinier Haga Orthopedisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

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