Overview

Discontinuing NSAIDs in Veterans With Knee Osteoarthritis

Status:
Completed
Trial end date:
2018-10-05
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
VA Office of Research and Development
Treatments:
Meloxicam
Criteria
Inclusion Criteria:

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.

Exclusion Criteria:

- 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.