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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment