Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

Study Overview
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Brief Summary
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The purpose of the study is to identify non-invasive strategies that will optimize the neurobiological environment and improve learning and memory in the treatment of chronic pain. The overall aims of the current proposal are to determine if food restriction and/or glucose administration in conjunction with a relaxation/guided imagery exercise will result in neurophysiological changes and functional improvements compared to the relaxation/guided imagery exercise alone.

Detailed Description
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Up to sixty adults with chronic knee pain with or/at risk of knee osteoarthritis will be randomized to one of three groups: food restriction (20 participants), glucose administration (20 participants), or control (20 participants). Participants will attend four sessions over a two to three week period.

Official Title
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Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

Conditions
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Pain, Osteoarthritis

Intervention / Treatment
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* Other: Glucose Administration
* Other: Intermittent Fasting
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with chronic knee pain with or/at risk of knee osteoarthritis Exclusion Criteria: Concurrent medical condition that could confound outcome measures or limit the ability to participate completely in the protocol including: neurological conditions (Parkinson's disease, multiple sclerosis, and/or seizures) History of a head injury or stroke Diabetes or taking medications to control blood sugar Mental health issues resulting in hospitalization or outpatient treatment in the past year, and/or psychotropic medication use Current issue or history of treatment for alcohol or other substance abuse Cognitive function < or = 22 on the Mini-Mental Status Exam Pregnancy A baseline fasting blood sugar (plasma glucose > 7mmol/L) or persisting blood pressure >150/95. Heart condition such as a prior heart attack, heart surgery (including a stent), frequent chest pain or heart failure Inability to complete the EEG portion of the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>For sessions 2 through 4, maintain normal eating patterns. | Other: Control<br>* Normal food intake<br>|
| Active Comparator: Glucose Administration<br>For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session. | Other: Glucose Administration<br>* For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session.<br>|
| Active Comparator: Intermittent Fasting<br>For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior). | Other: Intermittent Fasting<br>* For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neurophysiological measures | Electroencephalogram (EEG) amplitude measures. | baseline and 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Measure of lower extremity pain and function in persons with knee OA. | baseline and 3 weeks | 
| Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli | Quantitative sensory testing measure. | baseline and 3 weeks | 
| Change in Level of Distress measure - Perceived Stress Scale | Measure of perceived stress. | baseline and 3 weeks | 
| Change in Affect Measure - Positive and Negative Affect Schedule (PANAS) | Measure of positive and negative affect. | baseline and 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuroplasticity