Flexibility of Cognition And Persistent Pain

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT02579538
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Primary Completion: 2018-03-01
• Study Completion: 2018-12-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PPSP prevalence in relation to baseline TMT B minus A time	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	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy	up to one year	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
Multiple regression analysis	up to one year	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)

Trial Locations

Locations (1)

Washington University in Saint Louis; 🇺🇸 Saint Louis, Missouri, United States