Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OCR15965 | Other Identifier | University of Florida |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Pain Society | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | For sessions 2 through 4, maintain normal eating patterns. |
|
| Glucose Administration | Active Comparator | 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. |
|
| Intermittent Fasting | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose Administration | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurophysiological measures | Electroencephalogram (EEG) amplitude measures. | baseline and 3 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT) | Measure of verbal learning/memory | baseline and 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kimberly T Sibille, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Aging | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20883717 | Background | Smith MA, Riby LM, Eekelen JA, Foster JK. Glucose enhancement of human memory: a comprehensive research review of the glucose memory facilitation effect. Neurosci Biobehav Rev. 2011 Jan;35(3):770-83. doi: 10.1016/j.neubiorev.2010.09.008. Epub 2010 Sep 29. | |
| 23447797 | Background | Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intermittent Fasting | Other | 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). |
|
| Control | Other | Normal food intake |
|
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 |
| 16899414 | Background | Martin B, Mattson MP, Maudsley S. Caloric restriction and intermittent fasting: two potential diets for successful brain aging. Ageing Res Rev. 2006 Aug;5(3):332-53. doi: 10.1016/j.arr.2006.04.002. Epub 2006 Aug 8. |
| 21482550 | Background | Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10. |
| 26848123 | Background | Sibille KT, Bartsch F, Reddy D, Fillingim RB, Keil A. Increasing Neuroplasticity to Bolster Chronic Pain Treatment: A Role for Intermittent Fasting and Glucose Administration? J Pain. 2016 Mar;17(3):275-81. doi: 10.1016/j.jpain.2015.11.002. Epub 2016 Feb 2. |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |