Clinical trial NCT02681081: Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
Official title: Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Osteoarthritis
Keywords: Neuroplasticity
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Pain Society
First posted: 2016-02-12
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Neurophysiological measures
timeFrame: baseline and 3 weeks
Secondary outcomes:
measure: Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: baseline and 3 weeks
measure: Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli
timeFrame: baseline and 3 weeks
measure: Change in Level of Distress measure - Perceived Stress Scale
timeFrame: baseline and 3 weeks
measure: Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)
timeFrame: baseline and 3 weeks
Other outcomes:
measure: Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT)
timeFrame: baseline and 3 weeks
Locations:
city: Gainesville
country: United States
facility: Institute of Aging
state: Florida
Study officials:
affiliation: University of Florida
name: Kimberly T Sibille, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29.
citation: 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.
citation: 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.
citation: 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.