Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-07-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

For sessions 2 through 4, maintain normal eating patterns.

Group Type OTHER

Control

Intervention Type OTHER

Normal food intake

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.

Group Type ACTIVE_COMPARATOR

Glucose Administration

Intervention Type OTHER

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).

Group Type ACTIVE_COMPARATOR

Intermittent Fasting

Intervention Type OTHER

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).

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Control

Normal food intake

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes