Chronic PainNCT01900223
Chronic Pain After Shoulder Arthroplasty
An observational study of Chronic Pain, run by Karen Bjørnholdt.
Trial summary
Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as preoperative pain, severe acute postoperative pain, age… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 786 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Oct 2013
- 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: Patients in the Danish Shoulder Arthroplasty Register
Who may be able to join
- Patients operated with any shoulder prosthesis between april 2011 and april 2012 in Denmark
Who cannot join
- Secondary prosthesis
- Bilateral prosthesis
- Age below 18
- Reoperated in the same shoulder after the prosthesis
About this study
Official title: Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.
Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder prosthesis bearer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current pain intensity
Pain score by Numeric Rating Scale 0-10
Measured: At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis.
Secondary outcomes (1)
preoperative pain intensity
Pain intensity by Likert scale
Measured: recalled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Bjørnholdt
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, Augustinus Fonden, Horsens Hospital
- Responsible party
- Sponsor-investigator, Karen Bjørnholdt, University of Aarhus
- Investigators
- Karen T Bjørnholdt, M.D., Principal investigator, Aarhus University, Horsens HospitalBirgitte Brandsborg, M.D., Ph.D., Study chair, Aarhus University HospitalLone Nikolajsen, M.D., DMSc, Study chair, Aarhus University HospitalKjeld Søballe, M.D., DMSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900223
- Sponsor's protocol ID
- KTB-003
- Status last verified
- Jan 2014
- First submitted
- 8 Jul 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.
- ClinicalTrials.gov ID
- NCT01900223
- Acronym / sponsor ID
- KTB-003
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- Karen BjørnholdtUniversity, hospital or other
- Collaborators
- Central Denmark Region, Augustinus Fonden, Horsens Hospital
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Jul 2013 (estimated)
- 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.
Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder prosthesis bearer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Danish Shoulder Arthroplasty Register
Key inclusion criteria (1 listed)
- Patients operated with any shoulder prosthesis between april 2011 and april 2012 in Denmark
Key exclusion criteria (4 listed)
- Secondary prosthesis
- Bilateral prosthesis
- Age below 18
- Reoperated in the same shoulder after the prosthesis
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
Current pain intensity
Time frame: At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis.
Pain score by Numeric Rating Scale 0-10
1 secondary outcome
preoperative pain intensity
Time frame: recalled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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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.
Karen T Bjørnholdt, M.D. principal investigator
Aarhus University, Horsens Hospital
Birgitte Brandsborg, M.D., Ph.D. study chair
Aarhus University Hospital
Lone Nikolajsen, M.D., DMSc study chair
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Karen Bjørnholdt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current pain intensity (time frame: At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis.). 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 14 Jan 2014.