Prolozone M Therapy's Analgesic Efficacy for Managing Moderate-to-Severe Knee Osteoarthritis: A Randomized,...

Knee osteoarthritis is one of the most common disabling joint diseases in India. Nonsurgical management remains the only option for patients who are unwilling to undergo or unable to afford total knee arthroplasty.

Our study's primary objective was to compare the analgesic efficacy of intraarticular injection of either a combined hypertonic dextrose, ozone, and magnesium injectate with an injectate of corticosteroid only in patients with moderate-to-severe knee osteoarthritis. A third group received an intraarticular saline injection.

Prospective, randomized, double-blind, placebo-controlled study.

Pain medicine clinic at Sri Madhusudan Sai Institute of Medical Sciences and Research, a tertiary care medical college in the Republic of India.

Patients were randomly assigned to one of 3 groups (combined hypertonic dextrose, ozone, and magnesium; corticosteroid; or saline). Patients and the clinicians performing the injections were blinded to the treatment allocation. All study patients had moderate-to-severe primary osteoarthritis of the knee (a Kellgren Lawrence Grading Scale score of 3 or 4). They received a total of 3 intraarticular treatments-one every 3 weeks. Patients and follow-up assessors were both blinded. Follow-ups were conducted at 3, 6, 12, and 24 weeks post the first injection. The primary outcome criterion was the change from baseline to 24 weeks post the first injection in the Western Ontario and McMaster Universities Osteoarthritis Index A (pain) subscore.

A total of 180 patients with a Kellgren Lawrence Grading Scale score of 3 or 4 were randomly assigned. Baseline characteristics were similar. When compared to corticosteroids, patients in the Prolotherapy M Group had statistically significant greater improvements in their Western Ontario and McMaster Universities Osteoarthritis Index A (pain) subscore at 24 weeks post the first injection (mean, -2.3 [98.3% CI, -3.8 to -0.8], P < 0.001, d 0.88). Radiological images showed improvement at 24 weeks in the Prolotherapy M Group when compared to baseline.

This was a single-center study with a limited follow-up period.

Our placebo-controlled study showed that 3 injections of combined hypertonic dextrose, ozone, and magnesium is safe and efficacious in providing statistically significant, clinically relevant analgesia at 24 weeks post the first injection, with a significant difference vs corticosteroid only injections. There were early signs of chondroprotection with Prolozone M therapy.