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Clinical Trials in the Spotlight Main Page

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Investigators supported by the NIAMS need your help finding individuals to participate in clinical trials.  Participating in clinical trials allows you to play an active role as a volunteer in research and contribute to generating new knowledge about the disease/condition, and potentially future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible. 

Study Description

Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults and 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 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. However, stand-alone conservative treatments including non-opioid medications and joint injections provide only limited pain relief and functional improvement in a subset of knee OA sufferers. This has led to a high rate of opioid use in this population. The overarching goal of this proposal is to conduct a sequential parallel group randomized controlled trial (RCT) to rigorously evaluate the comparative-effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase I) and, among non-responders, the benefits of nonsurgical procedural interventions (Phase II) in three interrelated Aims.

Aim 1 will evaluate the effectiveness of individual and combined online cognitive behavioral therapy (PainTRAINER) and pharmacologic treatment (duloxetine) in improving pain and function for KOA patients compared to standard of care. Aim 2 will determine if genicular nerve radiofrequency ablation (RFA) or intra-articular injection of hyaluronic acid and steroid are more effective in improving outcomes than local anesthetic nerve block or SOC and help establish the role of these interventional treatments in the overall management of pain in KOA patients. Patients that have failed Phase I treatment will be provided with an opioid for severe pain management, if appropriate, allowing the study team to examine the opioid-sparing effects of these procedures in a subset of participants. Aim 3 will test whether clinical and psychosocial phenotypes predict short- and long-term treatment response. The knowledge gained will contribute to the development of translatable therapeutic strategies for the treatment of patients with KOA pain that will lead to opioid sparing effects.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:             18 Years to 90 Years   (Adult, Older Adult)

Sexes Eligible for Study:           All

Accepts Healthy Volunteers:  No

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

Study Design:

Allocation:       Randomized

Intervention Model: Sequential Assignment

Masking: Single (Participant)

Primary Purpose: Treatment

Study Location(s):

University of California San Diego, San Diego, California, United States, 92037

University of Florida, Gainesville, Florida, United States, 32608

University of Maryland Baltimore, Baltimore, Maryland, United States, 21201

Johns Hopkins, Baltimore, Maryland, United States, 21287

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02199

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Columbia University, New York, New York, United States, 10019

Wake Forest University, Winston-Salem, North Carolina, United States, 27517

Oregon Health and Science University, Portland, Oregon, United States, 97239

Vanderbilt University, Nashville, Tennessee, United States, 37232

University of Utah, Salt Lake City, Utah, United States, 84108

University of Virginia, Charlottesville, Virginia, United States, 22908

University of Washington, Seattle, Washington, United States, 98185

Study Website:

https://clinicaltrials.gov/ct2/show/NCT04504812?term=NCT04504812&draw=2&rank=1

Last Updated: June 2021