Clinical trial: Saline Injections vs Education and Exercise in Knee Osteoarthritis (NCT03843931)

Eligibility criteria:
Inclusion Criteria:

          1. Age ≥50 years.

          2. Body Mass index ≤ 35

          3. A clinical diagnosis of tibiofemoral OA in the target knee according to the American
             College of Rheumatology (12).

          4. Average knee pain in the last week during weight bearing activities of at least 4 on a
             0 to 10 points scale (0=no pain; 10=worst possible pain).

          5. Verification of clinical diagnosis by definite tibiofemoral OA on posterior-anterior
             weight bearing semi-flexed knee radiographs with severity equivalent to Kellgren and
             Lawrence grade 2 or more.

        Exclusion Criteria:

          1. Intra-articular treatments of any kind of either knee 3 months before inclusion

          2. Scheduled surgery during study participation

          3. Knee joint fluid aspiration within 3 month of baseline visit

          4. Participation in exercise therapy within 3 months of baseline visit

          5. Evidence of other inflammatory joint disease (e.g. rheumatoid arthritis or gout)

          6. History of knee surgery within 12 months

          7. History of arthroplasty in the target knee

          8. Use of oral glucocorticoids

          9. Use of synthetic or non-synthetic opioids

         10. Other musculoskeletal, neurological, medical conditions precluding participation in
             exercise

         11. Contraindications to intra-articular injections, such as wounds or skin rash over
             injection site.

         12. Contraindications to exercise

         13. Planning to start other treatment for knee OA in the study participation period

         14. Regional pain syndromes

         15. Generalised pain syndromes such as fibromyalgia

         16. Lumbar or cervical nerve root compression syndromes

         17. Any other condition or impairment that, in the opinion of the investigator, makes a
             potential participant unsuitable for participation or which obstruct participation,
             such as large knee joint effusion, uncontrolled diabetes, psychiatric disorders, or
             opiate dependency.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 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? 0