search
Back to results

Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness (OPTIMIZE)

Primary Purpose

Pain, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucose Administration
Intermittent Fasting
Control
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain focused on measuring Neuroplasticity

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Aging

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Control

Glucose Administration

Intermittent Fasting

Arm Description

For sessions 2 through 4, maintain normal eating patterns.

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.

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).

Outcomes

Primary Outcome Measures

Change in Neurophysiological measures
Electroencephalogram (EEG) amplitude measures.

Secondary Outcome Measures

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.
Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli
Quantitative sensory testing measure.
Change in Level of Distress measure - Perceived Stress Scale
Measure of perceived stress.
Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)
Measure of positive and negative affect.

Full Information

First Posted
February 2, 2016
Last Updated
July 12, 2019
Sponsor
University of Florida
Collaborators
American Pain Society
search

1. Study Identification

Unique Protocol Identification Number
NCT02681081
Brief Title
Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
Acronym
OPTIMIZE
Official Title
Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
American Pain Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteoarthritis
Keywords
Neuroplasticity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
For sessions 2 through 4, maintain normal eating patterns.
Arm Title
Glucose Administration
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intermittent Fasting
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Glucose Administration
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intermittent Fasting
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Normal food intake
Primary Outcome Measure Information:
Title
Change in Neurophysiological measures
Description
Electroencephalogram (EEG) amplitude measures.
Time Frame
baseline and 3 weeks
Secondary Outcome Measure Information:
Title
Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
Measure of lower extremity pain and function in persons with knee OA.
Time Frame
baseline and 3 weeks
Title
Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli
Description
Quantitative sensory testing measure.
Time Frame
baseline and 3 weeks
Title
Change in Level of Distress measure - Perceived Stress Scale
Description
Measure of perceived stress.
Time Frame
baseline and 3 weeks
Title
Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)
Description
Measure of positive and negative affect.
Time Frame
baseline and 3 weeks
Other Pre-specified Outcome Measures:
Title
Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT)
Description
Measure of verbal learning/memory
Time Frame
baseline and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly T Sibille, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Aging
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20883717
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.
Results Reference
background
PubMed Identifier
23447797
Citation
Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29.
Results Reference
background
PubMed Identifier
16899414
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.
Results Reference
background
PubMed Identifier
21482550
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.
Results Reference
background
PubMed Identifier
26848123
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.
Results Reference
background

Learn more about this trial

Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

We'll reach out to this number within 24 hrs