Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

Pain Clinical Trial

— OPTIMIZE  

Official title:

Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681081
• Other study ID #: IRB201400913
• Secondary ID: OCR15965
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 12, 2019

Study information

• Verified date: July 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis
• Pain

Intervention

Other:
• Glucose 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.
• Intermittent 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).
• Control
Normal food intake

Locations

Country	Name	City	State
United States	Institute of Aging	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	American Pain Society

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29. — View 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. Epub 2006 Aug 8. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT)	Measure of verbal learning/memory	baseline and 3 weeks
Primary	Change in Neurophysiological measures	Electroencephalogram (EEG) amplitude measures.	baseline and 3 weeks
Secondary	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
Secondary	Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli	Quantitative sensory testing measure.	baseline and 3 weeks
Secondary	Change in Level of Distress measure - Perceived Stress Scale	Measure of perceived stress.	baseline and 3 weeks
Secondary	Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)	Measure of positive and negative affect.	baseline and 3 weeks