Osteoarthritis, Pain
Conditions
Keywords
Neuroplasticity
Brief summary
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
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.
Interventions
OTHERGlucose Administration
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.
OTHERIntermittent Fasting
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).
OTHERControl
Normal food intake
Sponsors
American Pain Society
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Neurophysiological measures | baseline and 3 weeks | Electroencephalogram (EEG) amplitude measures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | baseline and 3 weeks | Measure of lower extremity pain and function in persons with knee OA. |
| Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli | baseline and 3 weeks | Quantitative sensory testing measure. |
| Change in Level of Distress measure - Perceived Stress Scale | baseline and 3 weeks | Measure of perceived stress. |
| Change in Affect Measure - Positive and Negative Affect Schedule (PANAS) | baseline and 3 weeks | Measure of positive and negative affect. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT) | baseline and 3 weeks | Measure of verbal learning/memory |
Countries
United States
Outcome results
None listed