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Cognitive Flexibility Training in Persistent Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2017
Last Updated
May 5, 2020
Sponsor
Washington University School of Medicine
Collaborators
Lumos Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03398408
Brief Title
Cognitive Flexibility Training in Persistent Pain
Official Title
Cognitive Flexibility Training in Persistent Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 29, 2017 (Actual)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Lumos Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Does cognitive training over five weeks improve cognitive flexibility performance scores in chronic hip, knee, and back pain patients?
Description
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.
Time Frame
Up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
ADD
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Links:
URL
https://www.iasp-pain.org/PublicationsNews/NewsDetail.aspx?ItemNumber=5134&navItemNumber=643
Description
IASP Task Force for the Classification of Chronic Pain in ICD-11 Prepares New Criteria on Postsurgical and Posttraumatic Pain

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Cognitive Flexibility Training in Persistent Pain

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