We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Cognitive Flexibility Training in Persistent Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398408
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Chronic Pain Behavioral: Training

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  (Clinical Trial)
Estimated 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 : December 29, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : July 30, 2020
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? [ Time Frame: Up to 5 months ]
    The primary outcome, i.e. NCPT score, will be assessed before and after five weeks of cognitive training. Paired t-test will be used to compare the change in NCPT score between the training and the control group.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398408


Contacts
Contact: Simon Haroutounian, PhD 314-286-1715 sharout@wustl.edu

Locations
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Simon Haroutounian, PhD    314-286-1715    sharout@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Lumos Labs, Inc.
Investigators
Principal Investigator: Simon Haroutounian, PhD Washington University School of Medicine
More Information

Additional Information:
Publications:

Responsible Party: simon.haroutounian, Assistant Professor of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03398408     History of Changes
Other Study ID Numbers: 201706064
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: ADD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms