*Erchonia Corporation study submitted to the FDA and given market clearance January 2002.
Background: This landmark study together with a companion 2000 study on pain reduction helped the Erchonia low level laser become the first low level laser of any kind to be approved by the FDA as safe and effective for treatment of chronic, minor pain.
Objectives: The purpose of this randomized, double-blind clinical study was to determine the effectiveness of the use of the Erchonia low level laser in providing temporary relief of chronic minor neck and shoulder pain. The primary outcome measure was the change in a subject’s self-reported degree of pain using the Visual Analog Scale (VAS) from immediately prior to the treatment administered to immediately after the treatment.
Methods: 100 subjects were enrolled at three different test sites. A total of 86 subjects completed the study, 43 in each of the test and the placebo group. Subjects were randomly assigned to either the test or placebo group. Subjects in the test group received the actual laser procedure using the specified treatment protocol and subjects in the placebo group received a “fake” laser treatment.
Results: 28 (65.1%) of the test subjects met individual success criteria in improvement of pain, while only 5 (11.6%) of the placebo subjects met this criteria. The overall study success criteria, defined as at least a 30% difference between groups, was exceeded. The actual difference in the proportion of individual subject successes between test and placebo group subjects was 53.5%. Analysis of the primary outcome from the study using a one-tailed z-test found that the proportion of individual successes for subjects in the test group who had received the actual laser treatment was significantly greater than the proportion of individual successes for subjects in the placebo group who received the “fake” treatment.
Conclusion: The Erchonia low level laser is a safe and effective device for single-use temporary pain relief and improvement in range of motion for patients with chronic pain in the neck and shoulder areas originating from the conditions of osteoarthritis, muscle spasms and cervical and thoracic spine strain.
Key Words: Low level laser, low power laser, LLLT, chronic pain, osteoarthritis, muscle spasms, cervical and thoracic spine strain