OsteoarthritisNCT02361359
Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty
An observational study of Osteoarthritis and Chronic Pain, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Chronic Pain, Catastrophization
- What is being tested?
- Psychological questionnaires
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Apr 2017
- 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 who undergo joint arthroplasty (shoulder, hip ou knee) for osteoarthritis
Who may be able to join
- joint arthgroplasty (shoulder, hip ou knee)
- osteoarthritis
Who cannot join
- previous surgery in the same joint
Trial locations and contacts
1 site in 1 country.
About this study
Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.
- Conditions
- Osteoarthritis, Chronic Pain, Catastrophization
- Being tested
- Psychological questionnaires
- Keywords
- Arthroplasty
- Medical subject headings
- Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological questionnairesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: 1 year postoperatively
Secondary outcomes (1)
Functional score
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361359
- Sponsor's protocol ID
- APR012014
- Status last verified
- May 2017
- First submitted
- 6 Feb 2015
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hardy A, Sandiford MH, Menigaux C, Bauer T, Klouche S, Hardy P. Pain catastrophizing and pre-operative psychological state are predictive of chronic pain after joint arthroplasty of the hip, knee or shoulder: results of a prospective, comparative study at one year follow-up. Int Orthop. 2022 Nov;46(11):2461-2469. doi: 10.1007/s00264-022-05542-7. Epub 2022 Aug 23.
PubMed 35999466
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02361359
- Acronym / sponsor ID
- APR012014
- Conditions
- Osteoarthritis, Chronic Pain, Catastrophization
- Keywords
- Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Feb 2015 (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.
Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.
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
- Patients who undergo joint arthroplasty (shoulder, hip ou knee) for osteoarthritis
Key inclusion criteria (2 listed)
- joint arthgroplasty (shoulder, hip ou knee)
- osteoarthritis
Key exclusion criteria (1 listed)
- previous surgery in the same joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological questionnaires | Other | – |
Primary outcome
Pain score
Time frame: 1 year postoperatively
1 secondary outcome
Functional score
Time frame: 1 year postoperatively
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 2 May 2017.
- Derived from this study: PubMed 35999466Hardy A, Sandiford MH, Menigaux C, Bauer T, Klouche S, Hardy P. Pain catastrophizing and pre-operative psychological state are predictive of chronic pain after joint arthroplasty of the hip, knee or shoulder: results of a prospective, comparative study at one year follow-up. Int Orthop. 2022 Nov;46(11):2461-2469. doi: 10.1007/s00264-022-05542-7. Epub 2022 Aug 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis and Chronic Pain, run by Hospital Ambroise Paré Paris at 1 site in France.
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 2 inclusion and 1 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 2 May 2017. 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 France. 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?
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?
Pain score (time frame: 1 year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361359, which also lists 1 linked publication.
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 2 May 2017.