Cognitive Flexibility Training in Persistent Pain

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 7, 2019

Detailed 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Does cognitive training over five weeks improve cognitive flexibility performance scores in chronic hip, knee, and back pain patients?
    • Time Frame: Up to 5 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Lumos Labs, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: simon.haroutounian, Assistant Professor of Anesthesiology – Washington University School of Medicine
  • Overall Official(s)
    • Simon Haroutounian, PhD, Principal Investigator, Washington University School of Medicine

References

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