What about patient satisfaction?
At week 52, all participants were asked, “Would you recommend the therapy you received in this study to others with knee OA like yours?” Ninety-one percent of the dextrose group, 82% of the saline group, and 89% of the exercise group answered “Yes.”
All participants who received injections reported mild to moderate post-injection pain. Five participants in the saline group and 3 in the dextrose group experienced bruising. No other side effects or adverse events were documented. According to daily logs of medication use in the 7 days after injection, 74% of patients in the dextrose group used acetaminophen and 47% used oxycodone, compared with 63% and 43%, respectively, in the saline group. The study authors did not comment on the significance of these differences.
WHAT'S NEW: A randomized study provides support for prolotherapy
This study is the first to adequately demonstrate improvement in knee-related quality of life with prolotherapy compared with placebo (saline) or exercise. Family physicians can now add this therapy to their “toolbox” for patient complaints of OA pain.
CAVEATS: Efficacy is unknown in patients with certain comorbidities
Efficacy is unknown in patients with certain comorbidities Of 894 people screened, only 118 met initial eligibility criteria. This study did not include patients who were taking daily opioids, had diabetes, or had a BMI >40, so its results may not be generalizable to such patients.
Also, while the study demonstrated no side effects or adverse events other than bruising in 8 patients, the sample size may have been too small to detect less common adverse events. However, prior studies of prolotherapy have not revealed any substantial adverse effects.7
Strong evidence for some conditions… not for others. The strongest data support the efficacy of prolotherapy for focal tendinopathy (lateral epicondylosis) and knee OA. Evidence supporting prolotherapy for multimodal conditions, such as chronic low back pain, is less robust.4
CHALLENGES TO IMPLEMENTATION: Finding a prolotherapist near you may not be easy
The main challenge to implementation is finding a certified prolotherapist, or obtaining training in the technique. The prolotherapy knee protocol can be performed in an outpatient setting in less than 15 minutes, but the technique requires training. Prolotherapy training is available from multiple organizations, including the American Association of Orthopaedic Medicine, which requires 100 course hours for prolotherapy certification.4 No formal survey on the number of prolotherapists in the United States has been conducted since 1993,13 but Rabago et al1 estimated that the number is in the hundreds.
Insurance coverage frequently is a challenge. Most third-party payers do not cover prolotherapy, and currently most patients pay out-of-pocket. Rabago et al1 indicated that at their institution, the cost is $218 per injection session. Another study published in 2010 put the average total cost of 4 to 6 prolotherapy sessions at $1800.14
And from the patient’s perspective … The multiple needle sticks involved in prolotherapy can be painful.
ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center for Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center of Research Resources or the National Institutes of Health.
