Pain, PostoperativeFlexCAPPNCT02579538
Flexibility of Cognition And Persistent Pain
An observational study of Pain, Postoperative, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing PPSP by preoperative administration of cognitive tests. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 1 Dec 2018
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are 18 to 85 years of age undergoing unilateral TKA for osteoarthritis, unilateral mastectomy for breast cancer, or thoracotomy or video-assisted thoracoscopic surgery for any non-cardiac indication will be recruited for participation in the study during their initial preoperative visit at the Washington University Center for Perioperative Assessment and Planning (CPAP). Patient eligibility will not be affected by the anesthetic plan including the potential use of regional anesthesia techniques.
Total Knee Arthroplasty (TKA) patients
- Inclusion criteria: Adults age 18 to 85 undergoing unilateral TKA for osteoarthritis English as primary language
- Exclusion criteria: Bilateral procedure Unable to complete cognitive testing Surgical indication for condition other than osteoarthritis (i.e. rheumatoid arthritis, spondylarthropathy) Prior knee surgery
_________________________________________________
Thoracotomy/mastectomy patients
- Inclusion criteria: Females age 18 to 85 undergoing mastectomy for breast cancer OR Adults age 18 to 85 undergoing unilateral open thoracotomy or video-assisted thoracoscopic surgery (VATS) for any non-cardiac etiology English as primary language
- Exclusion criteria: Bilateral procedure Unable to complete cognitive testing Plan for breast reconstruction Prior breast/thoracic surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: Cognitive Predictors of Persistent Post-surgical Pain (PPSP)
This observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing PPSP by preoperative administration of cognitive tests.
Read the detailed description
Postoperative pain is a normal, physiologic, protective response to tissue injury that routinely resolves after healing of the surgical site. However, in some patients, pain persists long after surgery. PPSP is a diagnosis of exclusion that has most consistently been defined as pain that (1) developed after a surgical procedure, (2) is not residual from a preexisting condition, (3) has lasted for at least two months, and (4) is not attributable to other causes. One suggested risk factor for PPSP is poorer performance on tests of cognitive flexibility. Two common tests of cognitive flexibility are the Trail Making Tests (TMT) A and B and the Color Word Matching Stroop Test (CWMST).
Three hundred patients undergoing either total knee arthroplasty or thoracotomy/mastectomy will be enrolled. During preoperative evaluation, participants will complete the TMT and CWMST. Subjects will be followed prospectively and will complete surveys at one month, six months, and one year postoperatively to assess PPSP prevalence and intensity.
- Conditions
- Pain, Postoperative
- Keywords
- Total Knee Arthroplasty, Thoracotomy, Mastectomy, Video-Assisted Thoracoscopic Surgery (VATS), Persistent Pain, Cognitive Flexibility
- Medical subject headings
- Pain, Postoperative
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 |
|---|---|---|
| Total Knee Arthroplasty | Patients undergoing unilateral total knee arthroplasty | |
| Thoracic/Breast Surgery | Patients undergoing mastectomy, thoracotomy, or video-assisted thoracoscopic surgery (VATS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPSP prevalence in relation to baseline TMT B minus A time
The time to complete TMT B test minus the time to complete TMT A test (B-A) at baseline between patients with persistent post surgical pain at six months follow-up, compared to patients without persistent post surgical pain.
Measured: Six months
PPSP prevalence in relation to baseline Stroop interference effect test score
The Stroop interference effect time (time to complete mixed color wording - time to complete same color wording) at baseline between patients with persistent post surgical pain at six months follow-up, compared to patients without persistent post surgical pain.
Measured: Six months
Secondary outcomes (2)
Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy
Association between baseline TMT B score and Stroop color interference effect results and severity of PPSP at six months follow-up in patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy
Measured: up to one year
Multiple regression analysis
Association of the following risk factors with PPSP at six months: cognitive flexibility (TMT and CWMST), age, gender, BMI, type of surgery, use of regional anesthesia, presence of preoperative pain, preoperative anxiety or depression, presence of prior stressful life events, and presence of severe acute postoperative pain)
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Mar 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Haroutounian, PhD, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579538
- Sponsor's protocol ID
- 201508145
- Acronym
- FlexCAPP
- Status last verified
- Jan 2020
- First submitted
- 9 Sep 2015
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Attal N, Masselin-Dubois A, Martinez V, Jayr C, Albi A, Fermanian J, Bouhassira D, Baudic S. Does cognitive functioning predict chronic pain? Results from a prospective surgical cohort. Brain. 2014 Mar;137(Pt 3):904-17. doi: 10.1093/brain/awt354. Epub 2014 Jan 17.
PubMed 24441173Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.
PubMed 23273105Solberg Nes L, Roach AR, Segerstrom SC. Executive functions, self-regulation, and chronic pain: a review. Ann Behav Med. 2009 Apr;37(2):173-83. doi: 10.1007/s12160-009-9096-5. Epub 2009 Apr 9.
PubMed 19357933Bonanno GA, Papa A, Lalande K, Westphal M, Coifman K. The importance of being flexible: the ability to both enhance and suppress emotional expression predicts long-term adjustment. Psychol Sci. 2004 Jul;15(7):482-7. doi: 10.1111/j.0956-7976.2004.00705.x.
PubMed 15200633McCracken LM, Vowles KE. Psychological flexibility and traditional pain management strategies in relation to patient functioning with chronic pain: an examination of a revised instrument. J Pain. 2007 Sep;8(9):700-7. doi: 10.1016/j.jpain.2007.04.008. Epub 2007 Jul 5.
PubMed 17611162Wicksell RK, Olsson GL, Hayes SC. Psychological flexibility as a mediator of improvement in Acceptance and Commitment Therapy for patients with chronic pain following whiplash. Eur J Pain. 2010 Nov;14(10):1059.e1-1059.e11. doi: 10.1016/j.ejpain.2010.05.001. Epub 2010 Jun 9.
PubMed 20538493Vila MR, Todorovic MS, Tang C, Fisher M, Steinberg A, Field B, Bottros MM, Avidan MS, Haroutounian S. Cognitive flexibility and persistent post-surgical pain: the FLEXCAPP prospective observational study. Br J Anaesth. 2020 May;124(5):614-622. doi: 10.1016/j.bja.2020.02.002. Epub 2020 Mar 10.
PubMed 32169255
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Predictors of Persistent Post-surgical Pain (PPSP)
- ClinicalTrials.gov ID
- NCT02579538
- Acronym / sponsor ID
- FlexCAPP / 201508145
- Conditions
- Pain, Postoperative
- Keywords
- Total Knee Arthroplasty, Thoracotomy, Mastectomy, Video-Assisted Thoracoscopic Surgery (VATS), Persistent Pain, Cognitive Flexibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 Oct 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.
This observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing PPSP by preoperative administration of cognitive tests.
Detailed description
Postoperative pain is a normal, physiologic, protective response to tissue injury that routinely resolves after healing of the surgical site. However, in some patients, pain persists long after surgery. PPSP is a diagnosis of exclusion that has most consistently been defined as pain that (1) developed after a surgical procedure, (2) is not residual from a preexisting condition, (3) has lasted for at least two months, and (4) is not attributable to other causes. One suggested risk factor for PPSP is poorer performance on tests of cognitive flexibility. Two common tests of cognitive flexibility are the Trail Making Tests (TMT) A and B and the Color Word Matching Stroop Test (CWMST).
Three hundred patients undergoing either total knee arthroplasty or thoracotomy/mastectomy will be enrolled. During preoperative evaluation, participants will complete the TMT and CWMST. Subjects will be followed prospectively and will complete surveys at one month, six months, and one year postoperatively to assess PPSP prevalence and intensity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | – | –Patients undergoing unilateral total knee arthroplasty |
| Thoracic/Breast Surgery | – | –Patients undergoing mastectomy, thoracotomy, or video-assisted thoracoscopic surgery (VATS) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are 18 to 85 years of age undergoing unilateral TKA for osteoarthritis, unilateral mastectomy for breast cancer, or thoracotomy or video-assisted thoracoscopic surgery for any non-cardiac indication will be recruited for participation in the study during their initial preoperative visit at the Washington University Center for Perioperative Assessment and Planning (CPAP). Patient eligibility will not be affected by the anesthetic plan including the potential use of regional anesthesia techniques.
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
PPSP prevalence in relation to baseline TMT B minus A time
Time frame: Six months
The time to complete TMT B test minus the time to complete TMT A test (B-A) at baseline between patients with persistent post surgical pain at six months follow-up, compared to patients without persistent post surgical pain.
PPSP prevalence in relation to baseline Stroop interference effect test score
Time frame: Six months
The Stroop interference effect time (time to complete mixed color wording - time to complete same color wording) at baseline between patients with persistent post surgical pain at six months follow-up, compared to patients without persistent post surgical pain.
2 secondary outcomes
Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy
Time frame: up to one year
Multiple regression analysis
Time frame: up to one year
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 28 Jan 2020.
- Background: PubMed 24441173Attal N, Masselin-Dubois A, Martinez V, Jayr C, Albi A, Fermanian J, Bouhassira D, Baudic S. Does cognitive functioning predict chronic pain? Results from a prospective surgical cohort. Brain. 2014 Mar;137(Pt 3):904-17. doi: 10.1093/brain/awt354. Epub 2014 Jan 17.
- Background: PubMed 23273105Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.
- Background: PubMed 19357933Solberg Nes L, Roach AR, Segerstrom SC. Executive functions, self-regulation, and chronic pain: a review. Ann Behav Med. 2009 Apr;37(2):173-83. doi: 10.1007/s12160-009-9096-5. Epub 2009 Apr 9.
- Background: PubMed 15200633Bonanno GA, Papa A, Lalande K, Westphal M, Coifman K. The importance of being flexible: the ability to both enhance and suppress emotional expression predicts long-term adjustment. Psychol Sci. 2004 Jul;15(7):482-7. doi: 10.1111/j.0956-7976.2004.00705.x.
- Background: PubMed 17611162McCracken LM, Vowles KE. Psychological flexibility and traditional pain management strategies in relation to patient functioning with chronic pain: an examination of a revised instrument. J Pain. 2007 Sep;8(9):700-7. doi: 10.1016/j.jpain.2007.04.008. Epub 2007 Jul 5.
- Background: PubMed 20538493Wicksell RK, Olsson GL, Hayes SC. Psychological flexibility as a mediator of improvement in Acceptance and Commitment Therapy for patients with chronic pain following whiplash. Eur J Pain. 2010 Nov;14(10):1059.e1-1059.e11. doi: 10.1016/j.ejpain.2010.05.001. Epub 2010 Jun 9.
- Derived from this study: PubMed 32169255Vila MR, Todorovic MS, Tang C, Fisher M, Steinberg A, Field B, Bottros MM, Avidan MS, Haroutounian S. Cognitive flexibility and persistent post-surgical pain: the FLEXCAPP prospective observational study. Br J Anaesth. 2020 May;124(5):614-622. doi: 10.1016/j.bja.2020.02.002. Epub 2020 Mar 10.
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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.
Simon Haroutounian, PhD principal investigator
Washington University in Saint Louis
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 Pain, Postoperative, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jan 2020. 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 United States. 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?
PPSP prevalence in relation to baseline TMT B minus A time (time frame: Six months). The study lists 2 primary outcomes in all. 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 NCT02579538, which also lists 7 linked publications.
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 28 Jan 2020.