Cognitive Flexibility Training in Persistent Pain

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT03398408
Collaborator
Lumos Labs, Inc. (Industry)
150
1
2
19.3
7.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Cognitive Flexibility Training in Persistent Pain
Actual Study Start Date :
Dec 29, 2017
Actual Primary Completion Date :
Aug 7, 2019
Actual Study Completion Date :
Aug 7, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Does cognitive training over five weeks improve cognitive flexibility performance scores in chronic hip, knee, and back pain patients? [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University in St. Louis Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine
  • Lumos Labs, Inc.

Investigators

  • Principal Investigator: Simon Haroutounian, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
simon.haroutounian, Assistant Professor of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03398408
Other Study ID Numbers:
  • 201706064
First Posted:
Jan 12, 2018
Last Update Posted:
May 6, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2020