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Completed

NCT Number: NCT02681081

Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness

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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Key information

Conditions

Pain Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Aging

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose Administration

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

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).

Control

Other

Normal food intake

Primary outcomes

  1. Change in Neurophysiological measures

    Time frame: baseline and 3 weeks

    Electroencephalogram (EEG) amplitude measures.

Secondary outcomes

  1. 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.

  2. Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli

    Time frame: baseline and 3 weeks

    Quantitative sensory testing measure.

  3. Change in Level of Distress measure - Perceived Stress Scale

    Time frame: baseline and 3 weeks

    Measure of perceived stress.

  4. Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)

    Time frame: baseline and 3 weeks

    Measure of positive and negative affect.

Other outcomes

  1. Change in Recall and Recognition measures - Hopkins Verbal Learning Test (HVLT)

    Time frame: baseline and 3 weeks

    Measure of verbal learning/memory

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • American Pain Society

Registry information

Acronym: OPTIMIZE

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2016
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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