Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness (OPTIMIZE)

July 12, 2019 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Institute of Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
For sessions 2 through 4, maintain normal eating patterns.
Other: Control
Normal food intake
Active Comparator: 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.
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.
Active Comparator: 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neurophysiological measures
Time Frame: baseline and 3 weeks
Electroencephalogram (EEG) amplitude measures.
baseline and 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: baseline and 3 weeks
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
Time Frame: baseline and 3 weeks
Quantitative sensory testing measure.
baseline and 3 weeks
Change in Level of Distress measure - Perceived Stress Scale
Time Frame: baseline and 3 weeks
Measure of perceived stress.
baseline and 3 weeks
Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)
Time Frame: baseline and 3 weeks
Measure of positive and negative affect.
baseline and 3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT)
Time Frame: baseline and 3 weeks
Measure of verbal learning/memory
baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

American Pain Society

Investigators

  • Principal Investigator: Kimberly T Sibille, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

July 12, 2019

Study Completion (Actual)

July 12, 2019

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400913
  • OCR15965 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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