PainOPTIMIZENCT02681081
Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
A study testing Glucose Administration and Intermittent Fasting in people with Pain and Osteoarthritis, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Glucose Administration and Intermittent Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with chronic knee pain with or/at risk of knee osteoarthritis
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain, Osteoarthritis
- Being tested
- Glucose Administration, Intermittent Fasting, Control
- Keywords
- Neuroplasticity
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose AdministrationOther
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 FastingOther
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).
ControlOther
Normal food intake
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | For sessions 2 through 4, maintain normal eating patterns. Receives: Other: Control |
| Glucose Administration | Active comparator | 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. Receives: Other: Glucose Administration |
| Intermittent Fasting | Active comparator | 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). Receives: Other: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neurophysiological measures
Electroencephalogram (EEG) amplitude measures.
Measured: baseline and 3 weeks
Secondary outcomes (4)
Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measure of lower extremity pain and function in persons with knee OA.
Measured: baseline and 3 weeks
Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli
Quantitative sensory testing measure.
Measured: baseline and 3 weeks
Change in Level of Distress measure - Perceived Stress Scale
Measure of perceived stress.
Measured: baseline and 3 weeks
Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)
Measure of positive and negative affect.
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Pain Society
- Responsible party
- Sponsor
- Investigators
- Kimberly T Sibille, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681081
- Sponsor's protocol ID
- IRB201400913
- Other IDs
- OCR15965
- Acronym
- OPTIMIZE
- Status last verified
- Jul 2019
- First submitted
- 2 Feb 2016
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith MA, Riby LM, Eekelen JA, Foster JK. Glucose enhancement of human memory: a comprehensive research review of the glucose memory facilitation effect. Neurosci Biobehav Rev. 2011 Jan;35(3):770-83. doi: 10.1016/j.neubiorev.2010.09.008. Epub 2010 Sep 29.
PubMed 20883717Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29.
PubMed 23447797Martin B, Mattson MP, Maudsley S. Caloric restriction and intermittent fasting: two potential diets for successful brain aging. Ageing Res Rev. 2006 Aug;5(3):332-53. doi: 10.1016/j.arr.2006.04.002. Epub 2006 Aug 8.
PubMed 16899414Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.
PubMed 21482550Sibille KT, Bartsch F, Reddy D, Fillingim RB, Keil A. Increasing Neuroplasticity to Bolster Chronic Pain Treatment: A Role for Intermittent Fasting and Glucose Administration? J Pain. 2016 Mar;17(3):275-81. doi: 10.1016/j.jpain.2015.11.002. Epub 2016 Feb 2.
PubMed 26848123
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Chronic Pain Treatment With Enhanced Neuroplastic Responsiveness
- ClinicalTrials.gov ID
- NCT02681081
- Acronym / sponsor ID
- OPTIMIZE / IRB201400913
- Conditions
- Pain, Osteoarthritis
- Keywords
- Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Pain Society
- Study start
- Feb 2016 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: ControlFor sessions 2 through 4, maintain normal eating patterns. |
| Glucose Administration | Active comparator | Other: Glucose AdministrationFor 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 | Active comparator | Other: Intermittent FastingFor 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). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with chronic knee pain with or/at risk of knee osteoarthritis
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose AdministrationFor 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 |
| Intermittent FastingFor 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 |
| ControlNormal food intake | Other | Control |
Primary outcome
Change in Neurophysiological measures
Time frame: baseline and 3 weeks
Electroencephalogram (EEG) amplitude measures.
4 secondary outcomes
Change in Clinical Pain measure - Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline and 3 weeks
Change in Experimental Pain measure - Temporal summation of punctate mechanical stimuli
Time frame: baseline and 3 weeks
Change in Level of Distress measure - Perceived Stress Scale
Time frame: baseline and 3 weeks
Change in Affect Measure - Positive and Negative Affect Schedule (PANAS)
Time frame: baseline and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 20883717Smith MA, Riby LM, Eekelen JA, Foster JK. Glucose enhancement of human memory: a comprehensive research review of the glucose memory facilitation effect. Neurosci Biobehav Rev. 2011 Jan;35(3):770-83. doi: 10.1016/j.neubiorev.2010.09.008. Epub 2010 Sep 29.
- Background: PubMed 23447797Hensch TK, Bilimoria PM. Re-opening Windows: Manipulating Critical Periods for Brain Development. Cerebrum. 2012 Jul;2012:11. Epub 2012 Aug 29.
- Background: PubMed 16899414Martin B, Mattson MP, Maudsley S. Caloric restriction and intermittent fasting: two potential diets for successful brain aging. Ageing Res Rev. 2006 Aug;5(3):332-53. doi: 10.1016/j.arr.2006.04.002. Epub 2006 Aug 8.
- Background: PubMed 21482550Cramer SC, Sur M, Dobkin BH, O'Brien C, Sanger TD, Trojanowski JQ, Rumsey JM, Hicks R, Cameron J, Chen D, Chen WG, Cohen LG, deCharms C, Duffy CJ, Eden GF, Fetz EE, Filart R, Freund M, Grant SJ, Haber S, Kalivas PW, Kolb B, Kramer AF, Lynch M, Mayberg HS, McQuillen PS, Nitkin R, Pascual-Leone A, Reuter-Lorenz P, Schiff N, Sharma A, Shekim L, Stryker M, Sullivan EV, Vinogradov S. Harnessing neuroplasticity for clinical applications. Brain. 2011 Jun;134(Pt 6):1591-609. doi: 10.1093/brain/awr039. Epub 2011 Apr 10.
- Background: PubMed 26848123Sibille KT, Bartsch F, Reddy D, Fillingim RB, Keil A. Increasing Neuroplasticity to Bolster Chronic Pain Treatment: A Role for Intermittent Fasting and Glucose Administration? J Pain. 2016 Mar;17(3):275-81. doi: 10.1016/j.jpain.2015.11.002. Epub 2016 Feb 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly T Sibille, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose Administration and Intermittent Fasting in people with Pain and Osteoarthritis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neurophysiological measures (time frame: baseline and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681081, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.