Clinical trial: Is Botox Effective in Relieving Pain From Knee Osteoarthritis? (NCT00279903)

Eligibility criteria:
Inclusion criteria:

          1. A history of knee joint pain for greater than 6 months.

          2. Medial or lateral tibiofemoral joint line tenderness.

          3. Unilateral knee pain 6/10 or greater, on average, on the visual analog scale (VAS),
             that interferes with function most days per week.

          4. Prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory
             medications, and physical therapy (quadriceps strengthening).

          5. Kellgren grade II or III radiographic changes of osteoarthritis.

        Exclusion criteria:

          1. Age less than 40 years.

          2. Anticoagulation with warfarin or heparin.

          3. Known allergy or sensitivity to any of the components of the study medications.

          4. Body mass index greater than 35.

          5. Previous major reconstructive surgery on the affected knee.

          6. Previous arthroscopic surgery on the affected knee in the past 12 months.

          7. History of crystal induced arthropathy.

          8. Use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular
             disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.

          9. History of or evidence of active rheumatologic disease, diabetes, severe peripheral
             neuropathy, clinically evident cardiac or respiratory disease that interferes with
             functional status, or other serious diseases, including psychiatric disorders.

         10. Evidence of recent alcohol or drug abuse, or history of medication misuse or
             addiction.

         11. Females who are pregnant, breastfeeding, or planning a pregnancy during the study, or
             who think that they may be pregnant at the start of the study, or females of
             childbearing potential who are unable or unwilling to use a reliable form of
             contraception during the study.

         12. Intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular
             knee hyaluronic acid injection in the past 6 months.

         13. Patients who rate their average daily pain as less than 6 on a 10 point VAS scale at
             the screening visit.

         14. Concurrent participation in another investigational drug or device study or
             participation in the 30 days immediately prior to study enrollment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment