Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

Not Applicable

Completed

• Conditions: Pain; Osteoarthritis
• Interventions: Other: Control; Other: Glucose Administration; Other: Intermittent Fasting

• Registration Number: NCT02681081
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Status Verified: 2019-07
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Adults with chronic knee pain with or/at risk of knee osteoarthritis

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	For sessions 2 through 4, maintain normal eating patterns.
Glucose Administration	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	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).

Primary Outcome Measures

Name	Time	Method
Change in Neurophysiological measures	baseline and 3 weeks	Electroencephalogram (EEG) amplitude measures.

Secondary Outcome Measures

Name	Time	Method
Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli	baseline and 3 weeks	Quantitative sensory testing measure.
Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	baseline and 3 weeks	Measure of lower extremity pain and function in persons with knee OA.
Change in Level of Distress measure - Perceived Stress Scale	baseline and 3 weeks	Measure of perceived stress.
Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)	baseline and 3 weeks	Measure of positive and negative affect.

Trial Locations

Locations (1)

Institute of Aging; 🇺🇸 Gainesville, Florida, United States