Cognitive Flexibility Training in Persistent Pain

Chronic Pain Clinical Trial

Official title:

Cognitive Flexibility Training in Persistent Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398408
• Other study ID #: 201706064
• Status: Completed
• Phase: N/A
• Start date: December 29, 2017
• Est. completion date: August 7, 2019

Study information

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

Clinical Trial Summary

To determine whether participation in a cognitive training program over a training period of five weeks improves cognitive flexibility in patients with chronic hip, knee, and back pain.

Description:

This project is a single-center prospective, randomized study to assess whether cognitive flexibility can be improved through training on a Lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain; and whether changes in cognitive flexibility will correlate with perceived pain scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 7, 2019
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults age 18 to 70 with chronic hip, knee, or low back pain for >3 months

• Documented moderate to severe chronic pain

• English as a primary language

• Access to a computer at home and an email account

Exclusion Criteria:

• Diagnosed Alzheimer's or documented severe cognitive impairment

• Lack of email/lack of basic computer skills

• Has undergone an interventional pain procedure within one week prior to enrollment

• Are scheduled to undergo a pain procedure during the five weeks of complete cognitive training

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Training
The intervention group will be provided with the cognitive training module and participants will be required to complete a targeted 36-minute daily training for 35 days.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Lumos Labs, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (18)

Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-40, table of contents. — View Citation

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

Baliki MN, Mansour AR, Baria AT, Apkarian AV. Functional reorganization of the default mode network across chronic pain conditions. PLoS One. 2014 Sep 2;9(9):e106133. doi: 10.1371/journal.pone.0106133. eCollection 2014. — View Citation

Bernardy K, Klose P, Busch AJ, Choy EH, Häuser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev. 2013 Sep 10;(9):CD009796. doi: 10.1002/14651858.CD009796.pub2. Review. — View Citation

Bowie CR, Harvey PD. Administration and interpretation of the Trail Making Test. Nat Protoc. 2006;1(5):2277-81. — View Citation

Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251. — View Citation

Dworkin RH, Panarites CJ, Armstrong EP, Malone DC, Pham SV. Healthcare utilization in people with postherpetic neuralgia and painful diabetic peripheral neuropathy. J Am Geriatr Soc. 2011 May;59(5):827-36. doi: 10.1111/j.1532-5415.2011.03403.x. — 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

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation

Kortte KB, Horner MD, Windham WK. The trail making test, part B: cognitive flexibility or ability to maintain set? Appl Neuropsychol. 2002;9(2):106-9. — View Citation

Kucyi A, Salomons TV, Davis KD. Cognitive behavioral training reverses the effect of pain exposure on brain network activity. Pain. 2016 Sep;157(9):1895-904. doi: 10.1097/j.pain.0000000000000592. — View Citation

Lamm C, Decety J, Singer T. Meta-analytic evidence for common and distinct neural networks associated with directly experienced pain and empathy for pain. Neuroimage. 2011 Feb 1;54(3):2492-502. doi: 10.1016/j.neuroimage.2010.10.014. Epub 2010 Oct 12. Review. — View Citation

Morrison GE, Simone CM, Ng NF, Hardy JL. Reliability and validity of the NeuroCognitive Performance Test, a web-based neuropsychological assessment. Front Psychol. 2015 Nov 3;6:1652. doi: 10.3389/fpsyg.2015.01652. eCollection 2015. — View Citation

Oosterman JM, Dijkerman HC, Kessels RP, Scherder EJ. A unique association between cognitive inhibition and pain sensitivity in healthy participants. Eur J Pain. 2010 Nov;14(10):1046-50. doi: 10.1016/j.ejpain.2010.04.004. Epub 2010 May 20. — View Citation

Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0. Review. — View Citation

Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. — View Citation

Uttl B, Graf P. Color-Word Stroop test performance across the adult life span. J Clin Exp Neuropsychol. 1997 Jun;19(3):405-20. — View Citation

Vachon-Presseau E, Tétreault P, Petre B, Huang L, Berger SE, Torbey S, Baria AT, Mansour AR, Hashmi JA, Griffith JW, Comasco E, Schnitzer TJ, Baliki MN, Apkarian AV. Corticolimbic anatomical characteristics predetermine risk for chronic pain. Brain. 2016 Jul;139(Pt 7):1958-70. doi: 10.1093/brain/aww100. Epub 2016 May 5. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does cognitive training over five weeks improve cognitive flexibility performance scores in chronic hip, knee, and back pain patients?	The primary outcome, i.e. NCPT score, will be assessed before and after five weeks of cognitive training. T-test will be used to compare the change in NCPT score between the training and the control group.	Up to 5 months

External Links

•   IASP Task Force for the Classification of Chronic Pain in ICD-11 Prepares New Criteria on Postsurgical and Posttraumatic Pain