RECRUITING

Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis

Conditions

Knee Osteoarthritis knee oa osteoarthritis knee pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a clinical trial of people who have pain due to knee osteoarthritis at Northwestern University Feinberg School of Medicine. The study will last for about 20 weeks. 180 qualified participants will be randomly assigned in a 1:1:1 ratio (60 participants per group) to one of three treatment groups: duloxetine, celecoxib, or placebo. Participants will have an Xray, knee MRI, brain MRI, blood draws, pain sensitivity testing, and asked to fill out questionnaires. The purpose of this study is to try to predict which participants will respond to the treatment.

Official Title

Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis

Quick Facts

Study Start:2024-02-26

Study Completion:2028-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06245109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:41 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female, age greater than 40 years, with no racial/ethnic restrictions; 2. Meet American College of Radiology (ACR) criteria for knee osteoarthritis (OA) based on radiographic evidence; 3. Knee pain most days of the week for the past month at screening; 4. Must have average pain score for the week prior to baseline of ≥ 4 (on a 0 to 10 NRS) 5. Must complete pain ratings on at least 4 out of 7 days prior to baseline 6. Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires; 7. Must be in generally stable health; 8. Must be able to return for all clinic visits; 9. Willing to remain stable on any concomitant therapies (TENs unit, ice, glucosamine chondroitin, cannabinoids, etc.) 10. Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate. 11. Ambulatory with or without a cane, brace(s), or walking stick (use of walker or wheelchair will be exclusionary)	1. Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy; 2. Functional class IV congestive heart failure; 3. Significant other medical disease such as uncontrolled hypertension, untreated diabetes mellitus, coronary or peripheral vascular disease, chronic obstructive lung disease, liver disease (Liver Function Tests \>3x Upper limit of normal) or malignancy; 4. Current use of illicit drugs or history (in last 12 months) of alcohol or drug abuse; 5. Current cannabinoid use for knee pain; 6. High dose opioid use, as defined as \> 50mg morphine equivalent/day; 7. Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk; 8. In the judgment of the investigator, unable or unwilling to follow protocol and instructions; 9. Intra-axial implants (e.g., spinal cord stimulators or pumps); 10. All exclusion criteria for Magnetic Resonance Imaging (MRI) safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia; 11. Currently breastfeeding, pregnant, or planning to become pregnant during the study; 12. Chronic neurologic conditions, e.g., Parkinson's; 13. Renal insufficiency (creatinine \>1.5 mg/dl) 14. Previous history of peptic ulcer or gastrointestinal bleeding 15. Current use of anticoagulants or platelet inhibitors other than aspirin (ASA) at ≤325 mg/day 16. Allergy to sulfonamide drugs, duloxetine, NSAIDs, or acetaminophen 17. Acute myocardial infarction or coronary artery bypass graft surgery, in the past 12 months 18. Recent injection into the index knee of hyaluronic acid or other substance in the last 6 months, or steroid in the last 90 days. 19. Severe lactose intolerance 20. Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs) at a therapeutic dose. Occasional use of these medications as a sleep aid will be allowed; however, participants will need to agree to remain on a stable dose of the medication while in the study. 21. Uncontrolled narrow-angle glaucoma

Inclusion Criteria

Exclusion Criteria

1. Male or female, age greater than 40 years, with no racial/ethnic restrictions;
2. Meet American College of Radiology (ACR) criteria for knee osteoarthritis (OA) based on radiographic evidence;
3. Knee pain most days of the week for the past month at screening;
4. Must have average pain score for the week prior to baseline of ≥ 4 (on a 0 to 10 NRS)
5. Must complete pain ratings on at least 4 out of 7 days prior to baseline
6. Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
7. Must be in generally stable health;
8. Must be able to return for all clinic visits;
9. Willing to remain stable on any concomitant therapies (TENs unit, ice, glucosamine chondroitin, cannabinoids, etc.)
10. Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.
11. Ambulatory with or without a cane, brace(s), or walking stick (use of walker or wheelchair will be exclusionary)

1. Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy;
2. Functional class IV congestive heart failure;
3. Significant other medical disease such as uncontrolled hypertension, untreated diabetes mellitus, coronary or peripheral vascular disease, chronic obstructive lung disease, liver disease (Liver Function Tests \>3x Upper limit of normal) or malignancy;
4. Current use of illicit drugs or history (in last 12 months) of alcohol or drug abuse;
5. Current cannabinoid use for knee pain;
6. High dose opioid use, as defined as \> 50mg morphine equivalent/day;
7. Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
8. In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
9. Intra-axial implants (e.g., spinal cord stimulators or pumps);
10. All exclusion criteria for Magnetic Resonance Imaging (MRI) safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia;
11. Currently breastfeeding, pregnant, or planning to become pregnant during the study;
12. Chronic neurologic conditions, e.g., Parkinson's;
13. Renal insufficiency (creatinine \>1.5 mg/dl)
14. Previous history of peptic ulcer or gastrointestinal bleeding
15. Current use of anticoagulants or platelet inhibitors other than aspirin (ASA) at ≤325 mg/day
16. Allergy to sulfonamide drugs, duloxetine, NSAIDs, or acetaminophen
17. Acute myocardial infarction or coronary artery bypass graft surgery, in the past 12 months
18. Recent injection into the index knee of hyaluronic acid or other substance in the last 6 months, or steroid in the last 90 days.
19. Severe lactose intolerance
20. Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs) at a therapeutic dose. Occasional use of these medications as a sleep aid will be allowed; however, participants will need to agree to remain on a stable dose of the medication while in the study.
21. Uncontrolled narrow-angle glaucoma

Contacts and Locations

Study Contact

Graeme Witte

CONTACT

3125034163

graeme.witte@northwestern.edu

Narina Simonian, BS, CCRC

CONTACT

3125035780

n-simonian@northwestern.edu

Principal Investigator

Thomas J Schnitzer, MD, PhD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

Thomas J Schnitzer, MD, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26

Study Completion Date2028-03-15

Study Record Updates

Study Start Date2024-02-26

Study Completion Date2028-03-15

Terms related to this study

Keywords Provided by Researchers

knee oa
knee osteoarthritis
osteoarthritis
knee pain

Additional Relevant MeSH Terms

Knee Osteoarthritis