Osteo Arthritis ShouldersEPMNCT05861960
Endogenous Pain Modulation Study
An observational study of Osteo Arthritis Shoulders and Osteoarthritis Shoulder, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Shoulders, Osteoarthritis Shoulder
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who are scheduled to undergo primary shoulder arthroplasty for shoulder osteoarthritis (OA) or rotator cuff tear arthropathy (CTA).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier Haga Orthopedic Center
Zoetermeer, 2725 NA
Nina Mathijssen, +31647208490, N.Mathijssen@rhoc.nl
About this study
Official title: 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.
Read more
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.
- Conditions
- Osteo Arthritis Shoulders, Osteoarthritis Shoulder
- Keywords
- Total shoulder arthroplasty, Osteoarthritis, Quantitative sensory testing, Conditioned pain modulation, Temporal summation
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: Before surgery, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start4 Mar 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis ShouldersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brechtje Hesseling, MSc, Principal investigator, Reinier Haga Orthopedisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861960
- Sponsor's protocol ID
- 2019-005-M
- Acronym
- EPM
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Pain Modulation in Patients With Shoulder Arthroplasty for Osteoarthritis
- ClinicalTrials.gov ID
- NCT05861960
- Acronym / sponsor ID
- EPM / 2019-005-M
- Conditions
- Osteo Arthritis Shoulders, Osteoarthritis Shoulder
- Keywords
- Total shoulder arthroplasty, Osteoarthritis, Quantitative sensory testing, Conditioned pain modulation, Temporal summation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who are scheduled to undergo primary shoulder arthroplasty for shoulder osteoarthritis (OA) or rotator cuff tear arthropathy (CTA).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)
Time frame: Before surgery
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).
Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)
Time frame: 3 months
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).
Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%)
Time frame: 6 months
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).
Percentage of patients with normal emporal summation (TS, TS value < 2 points)
Time frame: Before surgery
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).
Percentage of patients with normal emporal summation (TS, TS value < 2 points)
Time frame: 3 months
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).
Percentage of patients with normal emporal summation (TS, TS value < 2 points)
Time frame: 6 months
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 secondary outcomes
Mean pain score (NRS)
Time frame: Before surgery, 3 months, 6 months
Pain catastrophizing
Time frame: Before surgery, 3 months, 6 months
Coping strategies
Time frame: Before surgery, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brechtje Hesseling, MSc principal investigator
Reinier Haga Orthopedisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Shoulders and Osteoarthritis Shoulder, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brechtje Hesseling, MSc (+31792065595, onderzoek@rhoc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with adequate conditioned pain modulation (CPM, CPM value > 10%) (time frame: Before surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.