Discontinuing NSAIDs in Veterans With Knee Osteoarthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

Knee osteoarthritis (OA) is now recognized as a major health problem. It is the number one cause of lower extremity disability and has significant deleterious effects on quality of life. While there are numerous therapies available for knee OA, most have limited efficacy. Of particular concern, is the widespread use of nonsteroidal anti-inflammatory drugs (NSAIDs) for this disorder. Veterans, as a group, are at high risk for both gastrointestinal and cardiovascular NSAID-induced complications. In this study the investigators propose to examine whether replacing NSAIDs with cognitive behavioral therapy delivered by telephone is an effective strategy for Veterans with knee OA. Telephone-administered therapy is particularly appealing since Veterans with knee OA are more likely to have limited mobility. If successful, this program may result in significant cost-savings for both Veterans (decreased co-pays and transportation costs) and the VA (decreased hospitalizations due to NSAID induced toxicity).

Key facts

Study ID

NCT01799213

Run by

VA Office of Research and Development

People needed

490

Starts

2013-09-02

Expected to finish

2018-10-05

Last updated by the study team

2023-07-27

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will include those for whom a discontinuation trial of NSAIDs is most appropriate: 1) Veterans with knee pain despite NSAID use and/or 2) Veterans at relatively higher risk of NSAID toxicity 55-59 as ascertained by meeting 1 or more of the following 4 criteria:
• Answer affirmatively to the question: "Do you have some knee pain on most days over the past 3 months?"
• Have 1 or more risk factors for NSAID-induced nephrotoxicity (age greater than 60 years, atherosclerotic cardiovascular disease, current diuretic use, chronic renal insufficiency, congestive heart failure (New York Heart Association class I-II. Note, Class III and IV are excluded).
• Have 1 or more risk factors for NSAID-induced gastrointestinal toxicity (history of peptic ulcer disease, age > 65 years, concurrent use of daily ASA or corticosteroids), and are currently on a gastro-protective agent.
• Have 1 or more risk factors for NSAID-induced cardiovascular toxicity (prevalent cardiovascular disease, hypertension, hypercholesterolemia, diabetes, smoking, family history of early heart disease or age greater than 55 years for women).
• In addition, subjects must:
• Be age 20 years or older. While the usual cut off for knee OA is approximately 40 years, the investigators chose to lower the age cutoff as younger Veterans have a higher than expected risk of OA (see B.1).
• Have radiographic evidence of knee OA reported in the VistA electronic system.
• Be using an NSAID (other than daily ASA) for knee pain on most days of the month for at least the past 3 months.
• Be able to understand and speak English and have a telephone.
• Be willing to engage in a CBT program, to discontinue (or replace) their NSAID, and to restrict co-therapies to acetaminophen for 14 weeks.

You may not qualify if…

• Subjects desiring escalation of analgesics for their current level of knee pain as determined by endorsement of the following statement: "Is your knee pain bad enough that you want to talk to your doctor about taking stronger pain medications?"
• Current use of opioids and/or Celebrex.
• Current use of an NSAID (not including ASA) for a painful condition in addition to knee OA.
• Contraindications to chronic NSAID use: current use of warfarin or antiplatelet agent other than ASA, allergy to any NSAID, active upper gastrointestinal ulceration in the previous 30 days, upper gastrointestinal bleeding in the past year, history of gastroduodenal perforation or obstruction, cardiovascular event within the past 6 months (myocardial infarction, cerebrovascular event, coronary-artery bypass graft, invasive coronary revascularisation, or new-onset angina), severe congestive heart failure (New York Heart Association class III-IV), evidence of serious anemia, hepatic, renal (including nephrotic syndrome), or blood coagulation disorders, and pregnancy.
• **Though the investigators are proposing a RWT - and thus will not be initiating NSAID therapy - it would not be appropriate to continue NSAIDs (even when prescribed) in high-risk patients. The investigators acknowledge that these exclusion criteria limit generalizability, but the investigators feel justified to ensure subjects' safety.***
• Previous hyaluronic acid knee injections (within 6 months) or corticosteroid knee injections (within 3 months).
• Scheduled knee hyaluronic acid or corticosteroid injections, arthroscopy, or knee surgery.
• Co-morbid conditions that include the following: known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, or psoriatic arthritis), gout or pseudogout attack within the last 12 months, peripheral neuropathy or cardiopulmonary disease that limits walking more than knee pain, bone metastases or Paget's disease involving the lower extremities, and history of drug or alcohol abuse within the past 2 years, bilateral knee replacements or knee pain in the replaced knee only.
• Current involvement in litigation or receiving workmen's compensation.
• Hearing, cognitive impairment or mental illness, as determined by chart review that would preclude participation in a CBT program.
• For Women of Childbearing Age: Must not currently be pregnant, agree to avoid getting pregnant during the course of the study and should inform the study team if pregnancy occurs at any time during study participation.
• Previous meloxicam use discontinued due to lack of effective symptom relief
• Contraindications to prolonged NSAID use, per PI discretion.

Where it is running

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven, Connecticut, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
• Providence VA Medical Center, Providence, RI — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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