Cognitive Flexibility Training in Persistent Pain
1 other identifier
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2017
CompletedStudy Start
First participant enrolled
December 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2019
CompletedMay 6, 2020
May 1, 2020
1.6 years
December 28, 2017
May 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intervention
EXPERIMENTALPatients in both groups will complete paper-pencil TMT A and B and the CWMST, the computer-based TMT A and B and Color Match, and NCPT tests upon enrollment into the study. Participants in the intervention group will then be provided with the Lumosity cognitive flexibility training module and complete daily training for a total of five weeks. 1-3 days after completion of their training, all patients will be invited to complete the computerized versions of the TMT A and B, Color Match, and NCPT tests again on their personal computers.
Control
NO INTERVENTIONPatients in both groups will complete paper-pencil TMT A and B and the CWMST, the computer-based TMT A and B and Color Match, and NCPT tests upon enrollment into the study. Patients in the control group will complete all tests upon enrollment and approximately five weeks after their initial testing, but will not participate in training.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- Lumos Labs, Inc.collaborator
Study Sites (1)
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Related Publications (18)
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
PMID: 16698416BACKGROUNDHaroutiunian 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.
PMID: 23273105BACKGROUNDSmith 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.
PMID: 22395856BACKGROUNDDworkin 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.
PMID: 21568954BACKGROUNDClarke 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.
PMID: 24519537BACKGROUNDApfelbaum 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):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PMID: 12873949BACKGROUNDOosterman 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.
PMID: 20493746BACKGROUNDBaliki 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.
PMID: 25180885BACKGROUNDKucyi A, Salomons TV, Davis KD. Cognitive behavioral training reverses the effect of pain exposure on brain network activity. Pain. 2016 Sep;157(9):1895-1904. doi: 10.1097/j.pain.0000000000000592.
PMID: 27101426BACKGROUNDVachon-Presseau E, Tetreault 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.
PMID: 27190016BACKGROUNDLamm 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.
PMID: 20946964BACKGROUNDBernardy K, Klose P, Busch AJ, Choy EH, Hauser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2.
PMID: 24018611BACKGROUNDAttal 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.
PMID: 24441173BACKGROUNDBowie CR, Harvey PD. Administration and interpretation of the Trail Making Test. Nat Protoc. 2006;1(5):2277-81. doi: 10.1038/nprot.2006.390.
PMID: 17406468BACKGROUNDKortte 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. doi: 10.1207/S15324826AN0902_5.
PMID: 12214820BACKGROUNDUttl B, Graf P. Color-Word Stroop test performance across the adult life span. J Clin Exp Neuropsychol. 1997 Jun;19(3):405-20. doi: 10.1080/01688639708403869.
PMID: 9268815BACKGROUNDMorrison 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.
PMID: 26579035BACKGROUNDTombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.
PMID: 15010086BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Haroutounian, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesiology
Study Record Dates
First Submitted
December 28, 2017
First Posted
January 12, 2018
Study Start
December 29, 2017
Primary Completion
August 7, 2019
Study Completion
August 7, 2019
Last Updated
May 6, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
ADD