Prolozone Therapy for Osteoarthritis of the Knee Study

Phase 4

Active, not recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/11/059765

Lead Sponsor: Sri Madhusudan Sai Institute of Medical Sciences and Research,

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 180

Inclusion Criteria

Adult patients aged 40 years and above, who meet the American College of Rheumatology criteria for osteoarthritis (knee pain for most of the days of the previous month and osteophyte (s) at the joint line visible on X ray) 29, are willing to consent and have moderate-severe OAK. Clinical Severity: Patients should have a mean score of 1.5.
3.5 on WOMAC A sub score30, 31. Radiological Severity of Osteoarthritis of the knee is based on the criteria defined by Kellgren and Lawrence, which grades OAK into 0-4 grades32. This study will be including Grade 3 and Grade 4 Osteoarthritis of the knee.

Exclusion Criteria

Participants unwilling to provide consent Patients with mild OAK Participants with known history of drug allergy to bupivacaine, corticosteroid or lidocaine Patients on anticoagulant or antiplatelet medication Patients who have had a myocardial infraction in the last 6 months Patients with secondary OAK (gout, RA, Psoriasis) or generalized osteoarthritis Patients who have received intra articular steroids into any joint within 3 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from in mean WOMAC A sub score at 24 weeks after third treatment between groups	Change from in mean WOMAC A sub score at 24 weeks after third treatment between groups

Secondary Outcome Measures

Name	Time	Method
30 seconds sit to stand test	Baseline and at 3, 6, 12, 24 weeks after the third treatment
WOMAC Total score	Baseline and at 3, 6, 12, 24 weeks after the third treatment
Patient Satisfaction with management	24 weeks after the third treatment
Radiological change in knee joint space (DMO arm only)

Trial Locations

Locations (1): Sri Madhusudan Sai Institute of Medical Sciences and Research,
🇮🇳
Rural, KARNATAKA, India
Sri Madhusudan Sai Institute of Medical Sciences and Research,
🇮🇳Rural, KARNATAKA, India
Dr Niraj Gopinath
Principal investigator
9036119279
niraj.gopinath@smsimsr.org