Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04504812 | RECRUITING | Knee Osteoarthritis

A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain
Sponsor:

Johns Hopkins University

Brief Summary:

There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Duloxetine

Intra-Articular Injection

Nerve Procedure with long acting blocks

Nerve Procedure with nerve ablation

Pain Coping Skills Training

Best Practices

Phase

PHASE3

Detailed Description:

Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults. It represents a major global health and economic burden to individuals and society. The rates of KOA have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and population body mass index (BMI). Surgery is often employed to treat KOA, but it is associated with a high rate of persistent pain, and is not a permanent solution. Numerous nonsurgical therapies have been advocated to treat pain in patients with KOA yet are not often used in clinical care. The limited pain relief and functional improvement seen in a subset of knee OA sufferers has led to a high rate of opioid use and disability in this population. The overarching goal of this study is to conduct a sequential parallel group randomized controlled trial (RCT) to evaluate the comparative effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase 1) and, among those that indicate interest in obtaining further treatment and those not eligible for conservative treatment, the benefits of procedural interventions (Phase 2). This study will also evaluate whether clinical and psychosocial phenotypes predict short- and longer-term treatment response. The results of this study will examine the effectiveness of each tested intervention and provide meaningful information regarding effectiveness across key subgroups of participants.

Study Type : INTERVENTIONAL
Estimated Enrollment : 1800 participants
Masking : SINGLE
Masking Description : Individuals randomized to a nerve procedure will be blinded to whether they have a long acting block or nerve ablation.
Primary Purpose : TREATMENT
Official Title : A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain
Actual Study Start Date : 2021-02-01
Estimated Primary Completion Date : 2024-11-01
Estimated Study Completion Date : 2025-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Knee pain score of ≥4 and ≤ 9 on the Modified 4-Item BPI Pain Scale at pre-intervention screening
  • * Meets at least 1 of the 3 American College of Rheumatology (ACR) Classification criteria for knee osteoarthritis.
  • ACR criteria are
    • 1. At least three of the following using history and physical examination: age \>50 years old; morning stiffness \<30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth
    • 2. At least one of the following using history, physical examination, and radiographic findings + the presence of osteophytes: age \>50 years old; morning stiffness \<30 minutes; crepitus on active motion and osteophytes
    • 3. At least 5 of the following using history, physical examination, and laboratory findings: age \>50 years old; morning stiffness \<30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth; erythrocyte sedimentation rate (ESR) \<40 mm/hour; Rheumatoid Factor (RF) \<1:40; synovial fluid signs of osteoarthritis
    Exclusion Criteria
    • * \<18 years of age
    • * Any inability to complete study procedures, including, but not limited to inadequate resources to mitigate low English language literacy
    • * Refusal of randomization
    • * Knee pain exclusions: Pain during an average of \< 4 days per week over the past 3 months; pain in the index knee from a joint disease other than OA (e.g., infectious arthritis, rheumatoid arthritis, spondyloarthropathy)
    • * Medication exclusions: Report changes in analgesic medication dose within 2 weeks of baseline; oral morphine equivalent dose of \> 90 mg/d at baseline
    • * Medical condition exclusions: Severe vision or hearing impairment or any signs of cognitive impairment that would prevent comprehension of consent procedures, study measures, or procedures; unstable medical condition that presents an absolute or relative contraindication for participation in both arms (e.g., unstable angina, congestive heart failure); poorly controlled serious psychiatric condition that could prevent full participation or affect outcomes (e.g., suicidal ideation, active psychosis, poorly controlled depression, active substance abuse \[excluding tobacco, caffeine or moderate alcohol use\])
    • * Knee-specific medical condition exclusions: History of bilateral knee joint replacement arthroplasty total knee arthroplasty (TKA) or TKA in the affected knee; partial replacements may be eligible depending on physician judgment; scheduled joint replacement; history of unilateral TKA and complaints of KOA pain limited to the operated knee; Intra-articular viscosupplementation, steroid injection or arthroscopic surgery in the index knee within 12 weeks of baseline
    • * Pregnancy by self-report, report of intention to become pregnant (Phase 1), or as determined by urine pregnancy screening (if Standard of Care at site) (Phase 2). Due to the unknown effects of duloxetine on the developing fetus and newborn, and the potential harms of fluoroscopy in pregnancy, women who are pregnant or lactating or intend to get pregnant will not be included in this study. Those of childbearing potential will be asked to use reliable contraception during the course of their participation in the study and to notify the study team if they become pregnant during participation. Definition of reliable birth control will be defined as: Female and male sterilization (female tubal ligation or occlusion, male vasectomy); long-acting reversible contraceptives (LARC) methods (intrauterine devices, hormonal implants); short-acting hormonal methods (pill, mini pills, patch, shot, vaginal ring); barrier methods (condoms, diaphragms, sponge, cervical cap)
    • Phase 1 specific Exclusion Criteria- An individual who meets any of the following criteria will be excluded from participation in Phase 1 of this study and will be enrolled and randomized directly into Phase 2
      • * Known allergic reaction or medical condition that renders an individual unsuitable for Phase 1 study interventions, including closed-angle glaucoma, kidney disease (creatinine clearance \< 30 mL/ min), severe liver disease, known adverse reaction to duloxetine or another selective serotonin-norepinephrine reuptake inhibitor (SNRI), bipolar disorder or mania, high likelihood of drug interactions that could lead to side effects (e.g., serotonin syndrome in people on multiple drugs that inhibit serotonin reuptake including monoamine oxidase (MAO) inhibitors).
      • * Report failed trial of an adequate dose of duloxetine to relieve KOA symptoms over a 1-month period
      • * Have tried and failed two of the following: NSAIDS, physical therapy (there are many physical therapies so clinicians should exercise their judgment as to what constitutes 'failed' therapy), or weight loss (need determined by clinician) and refuses participation in Phase 1
      • * End-stage renal disease
      • * Unreliable access to the internet on a daily basis, i.e., sufficient access to participate in the study and may include public library access, cafe/coffee shop spaces, access to a friend or neighbor's wifi or hotspot, etc. (reliability determined on a site-by-site basis)
      • Phase 2 specific exclusion criteria- An individual who meets any of the following is excluded from sequential participation in Phase 1 and then Phase 2, and will instead be randomized as a "solo" recruit into Phase 1
        • * Inability to pay for interventions (insurance or otherwise)
        • * Medical condition exclusions: Untreated coagulopathy that could interfere with Phase 2 interventions; for automated implantable cardioverter-defibrillator that cannot be disabled before radiofrequency ablation (RFA), the investigator can consult cardiology, bioengineering or the device manufacturer before enrolling in phase 2 (i.e. not a definite exclusion criterion)
        • * Knee specific medical condition exclusions: Current local infection in the knee; ulcers or an open wound in the region of the index knee; underwent an adequate trial of any Phase 2 procedural study intervention in the study knee; severe needle phobia that cannot be addressed pharmacologically
A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain

Location Details

NCT04504812

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California Davis

Sacramento, California, United States, 95817

RECRUITING

United States, California

University of California San Diego

San Diego, California, United States, 92037

RECRUITING

United States, California

VA Medical Center San Diego

San Diego, California, United States, 92161

RECRUITING

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

RECRUITING

United States, Florida

University of Florida

Gainesville, Florida, United States, 32608

RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Georgia

Atlanta VA Medical Center

Decatur, Georgia, United States, 30033

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Maryland

Johns Hopkins

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Maryland

Walter Reed Army Medical Center

Bethesda, Maryland, United States, 20889

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02199

RECRUITING

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, New York

Weill Cornell University

New York, New York, United States, 10019

RECRUITING

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14623

RECRUITING

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

RECRUITING

United States, North Carolina

Wake Forest University

Winston-Salem, North Carolina, United States, 27517

RECRUITING

United States, Ohio

Cleveland VA Medical Center

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Ohio

University Hospitals

Cleveland, Ohio, United States, 44106

RECRUITING

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

RECRUITING

United States, Utah

University of Utah

Salt Lake City, Utah, United States, 84108

RECRUITING

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

RECRUITING

United States, Washington

University of Washington

Seattle, Washington, United States, 98185