Looking at ClinicalTrials.gov, the FDA approval appears to be based on the results of a single randomized, double blind, placebo-controlled clinical trial showing that Multi Radiance MR4 laser technology is more effective than placebo for reducing chronic neck and shoulder pain. The study, completed in São Paulo, Brazil, had 72 participants in two groups. One group received the active treatment and the other a placebo. They were treated twice a week for three consecutive weeks. The primary outcome was intensity of pain using the Visual Analog Pain Scale (VAS), and secondary outcomes were range of motion (ROM) of the neck and shoulders and patient satisfaction.
Inclusion criteria were chronic, at least three months, of episodic pain of the neck and or shoulder, etiology of sprain, strain or muscle spasms, VAS score of 50 or greater, ability to maintain a pre-study pain management regimen, and willingness to forgo new treatments while undergoing the study. Subjects with current, active chronic pain disease, such as chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis, and diabetic neuropathic pain were excluded. The results of the study were not posted on ClinicalTrials.gov and the full study could not be located for review.
Remember that FDA approval alone does not automatically result in coverage by insurance carriers or recommendation by the workers’ compensation guidelines. For example, the Neurolumen device, which delivers three types of energy, LED, laser and electrostimulation, was FDA approved as a 510(k) pain treatment device. Despite FDA approval, ODG does not recommend the treatment due to the lack of published studies demonstrating its effectiveness. In fact, ODG currently does not recommend cold lasers, low-level laser therapy (LLLT), light emitting diode therapy (LED), other Neurolumen-like devices, and phototherapy for chronic pain. ODG currently does recommend LLLT for impingement syndrome and adhesive capsulitis in the shoulder. ACOEM does not recommend LLLT for the shoulder. ACOEM makes no recommendation regarding laser therapy for the neck or shoulder based on insufficient evidence.
While the MR4 device shows promise for potentially becoming an effective adjunct option for the treatment of chronic neck and shoulder pain, numerous questions remain. The first and most obvious revolve around the fact that the results appear to be based on a single study. Was the study supported by the manufacturer? What is the cost of the treatment? Who can provide the treatment? How long does the benefit of the treatment last? Lastly, in a head-to-head comparison, how does the efficacy of this treatment compare to other established treatments?
While more information is needed about the MR4 device in order to determine where it should fit in the battle against chronic pain, I must admit that the technology is exciting. As such, we will closely monitor the advance of this technology in the weeks and months to come.