BACKGROUND: 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.
OBJECTIVE: 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.
STUDY DESIGN: Prospective, randomized, double-blind, placebo-controlled study.
SETTING: Pain medicine clinic at Sri Madhusudan Sai Institute of Medical Sciences and Research, a tertiary care medical college in the Republic of India.
METHODS: 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.
RESULTS: 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.
LIMITATION: This was a single-center study with a limited follow-up period.
CONCLUSION: 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.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
The study has some major limitations: 1. the prolozone group was younger; 2. the results 1fter 24 weeks were only a bit better compared with placebo and corticosteroids; 3. there were more flare-ups in the prolozone group after 3, 6, and 12 weeks; 4. the sampling of 30 cases of the prolozone group in which x-rays were done was not clear; 5. the measuring method of the grading was not clear; and 6. x-rays were done only in the prolozone group. As such, it is impossible to draw conclusions.
Physician rater
The authors performed a prospective, randomized, double-blind, placebo-controlled study to compare the analgesic efficacy of intra-articular injection of either a combined hypertonic dextrose, ozone, and magnesium injectate or an injectate of corticosteroid only in patients with moderate-to-severe knee osteoarthritis. A third group received an intra-articular saline injection. They received a total of 3 intra-articular treatments—one every 3 weeks. Follow-ups were conducted at 3, 6, 12, and 24 weeks after the first injection. 180 patients with a Kellgren-Lawrence Grading Scale score of 3 or 4 were randomly assigned. When compared to corticosteroids, the Prolotherapy M Group had statistically significant greater improvements in the pain index at 24 weeks after the first injection, and radiological images showed improvement from baseline. Injection of combined hypertonic dextrose, ozone, and magnesium is safe and effective.
Physician rater
The authors suggest symptomatic improvement with combined therapy (Prolozone M). However, it is probably too strong to claim that this treatment has a structural effect.
, McMaster University