Comparison of the analgesic efficacy of combined peri-articular hypertonic dextrose prolotherapy, intra-articular Magnesium and Ozone (Dextrose Magnesium Ozone Therapy) with Intra articular Corticosteroid in the management of moderate-severe Osteoarthritis of the Knee: Randomized Double-Blind, Placebo-controlled Trial

Osteoarthritis of the knee (OAK) can cause significant pain, dysfunction, distress and impaired quality of life affecting 3.3% of the worldwide population1. OAK is not just a disease of the cartilage. Pain generators in OAK are present in both intra and extra articular structures2 ,3. Initial management includes analgesic medications and physiotherapy. Patients who fail to respond have two major options that include intra-articular treatments and total knee replacement (TKR)4-7. TKR is a major and expensive undertaking. There is a 10-20% chance of persistent knee pain after TKR8, 9. Various intra-articular treatments have been trialed with an objective of providing pain relief, improving function and avoiding or delaying TKR. These include intra-articular corticosteroid (IACS), intra-articular platelet rich plasma (PRP) therapy, intra-articular hyaluronidase, hypertonic dextrose prolotherapy (HDP) and Ozone therapy4-7, 10-12. Hyaluronic acid is not recommended for routine use in the treatment of symptomatic OAK4.  IACS injection is the recommended standard treatment4. However, there is a potential for chondrotoxic and osteoporotic side effects5. PRP therapy requires specialized equipment and theatre setting to avoid infection (septic arthritis)6. Intra-articular ozone therapy has a good safety profile11, 12. However, analgesia beyond 6 months is questionable12.

Corticosteroid, PRP or Hyaluronidase target the intra articular pain generator while ignoring the extra-articular structures like ligaments and muscles. HDP involves peri-articular injections that targets intra and extra articular pain generators, is cost effective, has an excellent safety profile with potential regenerative benefits14, 15. However, it provides short-term benefit in OAK14-16.

Intra articular magnesium (IAM) has significant analgesic benefits following knee arthroscopy17. There is experimental evidence that IAM prevents progression of OAK18.

There have been no studies till date that has compared the effectiveness of combined Dextrose Magnesium Ozone (DMO) Therapy with corticosteroid Therapy. Our hypothesis is that by combining the regenerative, analgesic and immunomodulating properties of Hypertonic Dextrose, Ozone and Magnesium, durable analgesia and improved function can be provided at a low cost. The present study assesses analgesic efficacy of Dextrose Magnesium Ozone (DMO) Therapy when compared to IACS.