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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Meets American College of Rheumatology Classification criteria for knee osteoarthritis.

Exclusion Criteria:

  • - Any inability to complete study procedures, including, but not limited to low English language literacy.
  • - Inability to access the internet on a daily basis.
  • - Unstable medical condition that presents as an absolute or relative contraindication for participation (e.g., unstable angina, poorly controlled diabetes mellitus, end stage renal failure, automated implantable cardioverter-defibrillator that cannot be disabled before RFA).
  • - Severe untreated bleeding disorder (anticoagulants may be continued during phase II treatments in most patients) - Severe vision or hearing impairment or serious cognitive impairment that could interfere with consent or outcome assessment.
  • - Poorly controlled serious psychiatric condition.
  • - Active substance abuse.
  • - Scheduled joint replacement on the affected knee.
  • - History of unilateral total knee arthroplasty (TKA) with complaints of KOA pain limited to the operated knee.
- Ulcers or an open wound in the region of the index knee

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04504812
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Johns Hopkins University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven Cohen, MD
Principal Investigator Affiliation Johns Hopkins University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthrosis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Phase 1: Best Practices

Participants will receive an intervention from the best practices.

Active Comparator: Phase 1: Best Practices + Duloxetine

Participants will receive Duloxetine in addition to an intervention from the best practices.

Active Comparator: Phase 1:Best Practices + Duloxetine + Pain coping skills

Participants will receive Duloxetine and pain coping skills training in addition to an intervention from the best practices.

Active Comparator: Phase 2: Intra-Articular Injection (HA+)

Participants will receive an intra-articular injection.

Active Comparator: Phase 2: Nerve Procedure: Long Acting Blocks

Participants will receive a nerve blocking procedure.

Active Comparator: Phase 2: Nerve Procedure: Nerve Ablation

Participants will receive a nerve ablation procedure.

Interventions

Drug: - Duloxetine

Duloxetine is a drug that is used to improve pain and function in people with knee osteoarthritis (KOA). Duloxetine is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety disorder, fibromyalgia, and joint pain. It will be titrated up from 20 or 30mg according to a schedule provided by a study provider.

Combination Product: - Intra-Articular Injection

Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1mL depo methylprednisolone (a steroid) and 2mL 0.5% bupivacaine (an anesthetic) into the knee.

Procedure: - Nerve Procedure with long acting blocks

People assigned to receive this will have 1mL of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) injected into the knee.

Procedure: - Nerve Procedure with nerve ablation

People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee.

Behavioral: - Pain Coping Skills Training

Participants will be provided with a written manual that includes login information for the pain coping skills training website. They will be expected to log into the system weekly, work through the modules, and participate in skills practice. This intervention will be conducted in combination with best practices and duloxetine.

Other: - Best Practices

Best Practice includes treatments that experts recommend for knee arthritis pain. Best Practice can include topical or oral pain relievers, a structured exercise program, and weight management if BMI is over 30. Other non-invasive treatments such as acupuncture and yoga are also included.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, San Diego, California

Status

Recruiting

Address

University of California San Diego

San Diego, California, 92037

Site Contact

Research Coordinator

[email protected]

858-822-3108

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32608

Site Contact

Research Coordinator

[email protected]

352-273-8911

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Research Coordinator

[email protected]

312-695-0915

University of Maryland Baltimore, Baltimore, Maryland

Status

Recruiting

Address

University of Maryland Baltimore

Baltimore, Maryland, 21201

Site Contact

Research Coordinator

[email protected]

410-706-8421

Johns Hopkins, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins

Baltimore, Maryland, 21287

Site Contact

Research Coordinator

[email protected]

888-304-0711

Brigham and Women's Hospital, Boston, Massachusetts

Status

Recruiting

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02199

Site Contact

Research Coordinator

[email protected]

617-732-9463

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Research Coordinator

[email protected]

888-304-0711

Columbia University, New York, New York

Status

Recruiting

Address

Columbia University

New York, New York, 10019

Site Contact

Research Coordinator

[email protected]

917-701-5271

Cornell University, New York, New York

Status

Recruiting

Address

Cornell University

New York, New York, 10019

Site Contact

Research Coordinator

[email protected]

212-746-9419

Wake Forest University, Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University

Winston-Salem, North Carolina, 27517

Site Contact

Research Coordinator

[email protected]

336-716-8791

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Research Coordinator

[email protected]

503-494-2180

Vanderbilt University, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University

Nashville, Tennessee, 37232

Site Contact

Research Coordinator

[email protected]

615-936-7046

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84108

Site Contact

Research Coordinator

[email protected]

801-587-1436

University of Virginia, Charlottesville, Virginia

Status

Recruiting

Address

University of Virginia

Charlottesville, Virginia, 22908

Site Contact

Research Coordinator

[email protected]

434-409-1058

University of Washington, Seattle, Washington

Status

Recruiting

Address

University of Washington

Seattle, Washington, 98185

Site Contact

Research Coordinator

[email protected]

206-616-2673