Cognitive Flexibility Training in Persistent Pain

NCT ID: NCT03398408

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-29

Study Completion Date

2019-08-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

Patients 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.

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

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.

Control

Patients 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lumos Labs, Inc.

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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simon.haroutounian

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Haroutounian, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16698416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23273105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22395856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21568954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24519537 (View on PubMed)

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):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

Reference Type BACKGROUND
PMID: 12873949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20493746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25180885 (View on PubMed)

Kucyi A, Salomons TV, Davis KD. Cognitive behavioral training reverses the effect of pain exposure on brain network activity. Pain. 2016 Sep;157(9):1895-1904. doi: 10.1097/j.pain.0000000000000592.

Reference Type BACKGROUND
PMID: 27101426 (View on PubMed)

Vachon-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.

Reference Type BACKGROUND
PMID: 27190016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20946964 (View on PubMed)

Bernardy 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.

Reference Type BACKGROUND
PMID: 24018611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24441173 (View on PubMed)

Bowie CR, Harvey PD. Administration and interpretation of the Trail Making Test. Nat Protoc. 2006;1(5):2277-81. doi: 10.1038/nprot.2006.390.

Reference Type BACKGROUND
PMID: 17406468 (View on PubMed)

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. doi: 10.1207/S15324826AN0902_5.

Reference Type BACKGROUND
PMID: 12214820 (View on PubMed)

Uttl 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.

Reference Type BACKGROUND
PMID: 9268815 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26579035 (View on PubMed)

Tombaugh 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.

Reference Type BACKGROUND
PMID: 15010086 (View on PubMed)

Related Links

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https://www.iasp-pain.org/PublicationsNews/NewsDetail.aspx?ItemNumber=5134&navItemNumber=643

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

Other Identifiers

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201706064

Identifier Type: -

Identifier Source: org_study_id

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