Flexibility of Cognition And Persistent Pain

Pain, Postoperative Clinical Trial

— FlexCAPP  

Official title:

Cognitive Predictors of Persistent Post-surgical Pain (PPSP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579538
• Other study ID #: 201508145
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

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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

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

Bonanno 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. — View Citation

Haroutiunian 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. Review. — View Citation

McCracken 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. Epub 2007 Jul 5. — View Citation

Solberg 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. Review. — View Citation

Wicksell 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Six months
Primary	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.	Six months
Secondary	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	up to one year
Secondary	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)	up to one year