Cognitive Flexibility Training in Persistent Pain

Study Overview
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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.

Official Title
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Cognitive Flexibility Training in Persistent Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 months |