OxyRub Clinical Trials

The base product for the revolutionary OxyRub PRO – the professional strength topical analgesic created by Dr. Joseph Pergolizzi, Jr. – is OxyRub, the pain reliever originally created by Dr. Pergolizzi several years back.

In several clinical trials, OxyRub was tested in various settings. In these studies, the products used allowed for the minimal effective dose, that is, the lowest dose possible that achieved the most powerful results. This is a variation on the old clinical adage, “start low and go slow.” These studies evaluated the original OxyRub formulation. The concept of “start low and go slow” led to the creation of OxyRub PRO for a multimechanistic professional-strength topical pain reliever designed to be used in chiropractor-directed pain care.

In one clinical study, OxyRub was evaluated head-to-head against a topical menthol-only pain reliever.1 The study compared two topical analgesics:

  • One contained menthol.
  • The other contained menthol with the addition of oxygenated glycerol triesters (OGTs), sometimes described to patients as essential oxygen oil.

The first (menthol only) was the control agent, and the latter (menthol plus OGTs was OxyRub).

The study was designed as a randomized, double-blind, single-center study. A total of 63 adults with musculoskeletal pain were enrolled and evaluated over a seven-day treatment period. Patients were randomized into the menthol-only group (control) or the menthol plus OGT group (OxyRub) and self-reported their pain, functional limitations, and mobility of the affected area three times a day. Pain was reported using a 100 mm visual analog scale (VAS).

Compared to pain at baseline, both groups experienced statistically significant pain relief at Day 8. The patients in the OGT group had significantly greater pain relief than the control group (p=0.016) and their pain decremented over each of the seven days of follow-up. The OGT patients also had greater improvements in lifestyle and mobility than the control patients. No serious adverse events occurred and both products were well tolerated by patients. There were no clinically significant skin reactions in either of the two study groups.

This was not the only clinical trial to evaluate OxyRub scientifically. In 2010, a report was published on a large, open-label trial of OGT topical pain reliever (n=455) in which 80% of patients in the study reported a pain decrease of ≥75%.2 The topical product was well tolerated with no serious adverse events reported. Clinical tolerance was reported to be excellent in 96% of cases and discontinuation of treatment occurred in <1% of cases.

In a double-blind, placebo-controlled study of 50 patients acute with tendinitis, patients applied about 2 mL of OGT oil twice daily to the affected area and massaged the oil into the skin before applying a compress over the area.2 Patients could take other pain relievers over the course of the study, which lasted seven days. Compliance, measured in how much of the oil was left at the end of the study was deemed to be good in all patients (no more than one application per day was missed). Pain was significantly decreased in both groups compared to baseline (p<0.001). The OGT group had statistically significantly better results in terms of pain control (p<0.025), spontaneous pain evaluation at rest (p<0.05), time to improvement (p<0.05), patient’s evaluation of the treatment (p<0.02), and the physician’s final assessment of results (p<0.05).

In a randomized, placebo-controlled study, 50 patients with various pain diagnoses were enrolled and patients with skin allergies excluded.2 OGT resulted in “very good” pain relief in 98% of patients compared to 48% who reported “very good” pain relief in the control group.2 Results occurred in 10 days or fewer in 72% of the OGT group. The OGT oil was effective against pain, warmth, swelling, mobility, and relieving stiffness. No patients in this study discontinued treatment and the product was well tolerated.

Microcirculatory effects were evaluated in a randomized, double-blind, controlled study (n=10) where the OGT oil was massaged into the skin.2 This study did not enroll pain patients or evaluate pain control. Oil was applied in three locations on the inside of each forearm between the elbow and the wrist and neither subjects nor investigators knew which oil was the active agent or control (placebo oil). There was a detectable but not statistically significant increase in oxygen in the skin with OGT. The study lasted four weeks and while the main effect occurred within two weeks, moisture continued to increase in the skin in the OGT areas over the four-week study period, but the difference did not achieve statistical significance. No adverse events were reported.

In a postmarketing study, 100 American patients who used OxyRub were mailed a questionnaire.2 The study had a response rate of 10% (n=10) and 30% of patients at baseline had been using the OGT product (OxyRub original formulation) for more than six months. Most patients (60%) had learned about the product “from a friend.” All respondents were either “satisfied” or “very satisfied” with the product and used it more than once a week. Half reported using the product every day. When asked to compare OxyRub to other similar products on the market, 90% said the quality was “high” and “much better” than comparable topicals. Complete pain relief (100%) was reported by 40% of respondents, while 50% reported 90% pain relief. Every respondent in this survey said he or she intended to keep using OxyRub in the future.

In summary, OxyRub (OGT oil) has been clinically studied with promising results:

  • Significant pain relief versus control products
  • Well tolerated by patients with no serious adverse effects
  • Good patient compliance
  • Satisfaction with product and desire to keep using it

Clinical trials are the mainstay of evidence-based medicine but, in the end, they can only report results in a highly controlled subset of carefully selected patients. The true measure of success for OxyRub and OxyRub PRO is their use in the real-world clinical environment. But based on these studies, it is likely that patients will tolerate the product, obtain significant pain relief from it, and use it compliantly. These are important factors to consider when recommending analgesic products to your patients.

References

  1. Taylor R, Jr., Gan TJ, Raffa RB, et al. A randomized, double-blind comparison shows the addition of oxygenated glycerol triesters to topical mentholated cream for the treatment of acute musculoskeletal pain demonstrates incremental benefit over time. Pain practice: the official journal of World Institute of Pain. 2012;12(8):610-619.
  2. Pergolizzi JV, Pappagallo M, Raffa RB, et al. Preliminary observations of a novel topical oil with analgesic properties for treatment of acute and chronic pain syndromes. Pain practice: the official journal of World Institute of Pain. 2010;10(3):201-213.

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