Clinical trial: Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis (NCT02832713)

Eligibility criteria:
Inclusion Criteria:

          -  Painful, or predominantly unilateral painful, knee osteoarthritis of any etiology

          -  Knee without clinical signs of intra-articular effusion

          -  Kellgren score ≥ II on X-ray

          -  WOMAC pain sub-score ≥ 5 in the month preceding the inclusion visit

        Exclusion Criteria:

        Clinical:

          -  Inflammatory arthropathy,infectious, neoplastic within the past year

          -  Neuromuscular pathology

          -  Cardiorespiratory pathology or any other severe disease that interferes with the
             functional capacities

          -  Any decompensated or unstable chronic pathology

          -  Glomerular filtration rate (GFR)<15 mL/min/1.73m²) within the past 6 months

          -  HBA1c in diabetic people > 12% within the past 6 months

          -  BMI ≥ 35kg/m2

          -  Infection: joint, general, distant, cutaneous

          -  Foreign material in the knee to be treated: prosthesis, osteosynthesis material

          -  Severe coagulation problem: platelets <100000/mm3 within the past 6 months

          -  Allergy to BoNT-A

          -  Allergy to HA

          -  Pregnant or breast-feeding women

          -  Treatment with aminoglycosides or direct oral anticoagulants

          -  Treatment with VKA (antihemorrhagic vitamin) if INR (International Normalized Ratio)
             higher than 3 within the past month

          -  Change of anti-pain treatment less than 2 weeks before enrolment

          -  Treatment with III pain killers or corticosteroids because of intense pain that does
             not respond to schedule I and II pain-killers

          -  Intra-articular injection of corticosteroids in the previous two months

          -  Viscosupplementation and/or injection of BoNT-A in the knee to be treated within the
             past 6 months

          -  Injection of BoNT-A (except the knee to be treated) within the past 3 months

          -  Swallowing troubles
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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