Knee OsteoarthritisNCT01811888
Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
An observational study of Knee Osteoarthritis, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Quantitative sensory testing (QST)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2015
- 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 with knee osteoarthritis scheduled for total knee artheroplasty.
Who may be able to join
- Older than 18 patients
- Scheduled for primary total knee arthroplasty
- Disposition to visits and scheduled tests
Who cannot join
- Previous surgery on knee to be operated
- Documented peripheral neuropathy
- Severe disease or condition that could potentially interfere with interpretation of tests.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio d'Anestesia i Reanimació, Hospital del Mar
Barcelona, Barcelona, 08003
About this study
This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
- Conditions
- Knee Osteoarthritis
- Being tested
- Quantitative sensory testing (QST)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testing (QST)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Not described Receives: Behavioral: Quantitative sensory testing (QST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain in the operated knee, 6 months after surgery.
Measured: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
Secondary outcomes (1)
Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.
Measured: From start of recruitment untill day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
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 Knee 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CDursteler, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811888
- Sponsor's protocol ID
- TKAPAIN
- Status last verified
- Mar 2016
- First submitted
- 13 Mar 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dursteler C, Salazar Y, Rodriguez U, Pelfort X, Verdie LP. Conditioned pain modulation predicts persistent pain after knee replacement surgery. Pain Rep. 2021 Mar 29;6(1):e910. doi: 10.1097/PR9.0000000000000910. eCollection 2021 Jan-Feb.
PubMed 33817538
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.
- ClinicalTrials.gov ID
- NCT01811888
- Acronym / sponsor ID
- TKAPAIN
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Mar 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.
This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | – | Behavioral: Quantitative sensory testing (QST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis scheduled for total knee artheroplasty.
Key inclusion criteria (3 listed)
- Older than 18 patients
- Scheduled for primary total knee arthroplasty
- Disposition to visits and scheduled tests
Key exclusion criteria (3 listed)
- Previous surgery on knee to be operated
- Documented peripheral neuropathy
- Severe disease or condition that could potentially interfere with interpretation of tests.
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 |
|---|---|---|
| Quantitative sensory testing (QST) | Behavioural | Patients with knee osteoarthritis |
Primary outcome
Presence of pain in the operated knee, 6 months after surgery.
Time frame: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.
1 secondary outcome
Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.
Time frame: From start of recruitment untill day 180.
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 31 Mar 2016.
- Derived from this study: PubMed 33817538Dursteler C, Salazar Y, Rodriguez U, Pelfort X, Verdie LP. Conditioned pain modulation predicts persistent pain after knee replacement surgery. Pain Rep. 2021 Mar 29;6(1):e910. doi: 10.1097/PR9.0000000000000910. eCollection 2021 Jan-Feb.
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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 Knee Osteoarthritis, run by Parc de Salut Mar at 1 site in Spain.
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 3 inclusion and 3 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 31 Mar 2016. 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 Spain. 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?
Presence of pain in the operated knee, 6 months after surgery. (time frame: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.). 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 NCT01811888, 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 31 Mar 2016.