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Flexibility of Cognition And Persistent Pain

Cognitive Predictors of Persistent Post-surgical Pain (PPSP)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02579538
Acronym
FlexCAPP
Enrollment
300
Registered
2015-10-19
Start date
2015-09-01
Completion date
2018-12-01
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Total Knee Arthroplasty, Thoracotomy, Mastectomy, Video-Assisted Thoracoscopic Surgery (VATS), Persistent Pain, Cognitive Flexibility

Brief 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.

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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 \-

Design outcomes

Primary

MeasureTime frameDescription
PPSP prevalence in relation to baseline TMT B minus A timeSix monthsThe 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 scoreSix monthsThe 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.

Secondary

MeasureTime frameDescription
Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomyup to one yearAssociation 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
Multiple regression analysisup to one yearAssociation 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026