Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness (OPTIMIZE)

University of Florida

Status: Completed

Conditions: Osteoarthritis; Pain

Treatments: Other: Glucose Administration; Other: Control; Other: Intermittent Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT02681081

OCR15965 (Other Identifier)

IRB201400913

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 3 patient groups

Control

Other group

Description:

For sessions 2 through 4, maintain normal eating patterns.

Treatment:

Other: Control

Glucose Administration

Active Comparator group

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.

Treatment:

Other: Glucose Administration

Intermittent Fasting

Active Comparator group

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).

Treatment:

Other: Intermittent Fasting