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Neck & Shoulder Pain

Erchonia Medical began their commitment to conducting clinical research in December 1999, with Neck and Shoulder studies, as a means to prove viability to the FDA. At the time, the FDA considered low-level lasers "experimental" as no company had presented ethical clinical data to prove them safe and effective. Erchonia Medical petitioned the FDA regarding a study, choosing neck and shoulder pain because it was one of the most common neuromuscular conditions of which few devices had been proven successful in treating.

The study began December 1999 and was completed August 2000. The data collected on pain control was so impressive we were certain the FDA would grant market clearance without hesitation. Erchonia Medical presented the results to the FDA in a 510(k) submission and for months the FDA told us the study was good. However, in January 2001, owing to the FDA's years of doubt regarding low-level lasers, they requested a second study: one that was more limiting. In our first study we mixed patients suffering from both chronic and acute neck and shoulder pain. The FDA wanted us to target either acute OR chronic patients. You can imagine the frustration we at Erchonia Medical felt, however, being committed to our course we persevered.

Sensing the FDA's hesitation based on their long held opinion, that low-level lasers were "experimental" Erchonia Medical took a proactive approach. Steven Shanks, along with Erchonia Medical's regulatory agent hosted a conference call with the FDA to discuss the strict inclusion criteria they wanted for the next study. We addressed all their concerns and ensured test criteria were included in the clinical trial matrix to address each of them. Erchonia Medical again chose chronic neck and shoulder pain since we felt that if we proved this indication, it would demonstrate to the FDA, what we already knew, the incredible healing power of the Erchonia laser.

The inclusion criteria consisted of:

  • Pain on a visual analog scale
  • Pain greater than 50 on a scale of 1 to 100
  • Patient had to have had the pain longer than 30 days
  • No pharmaceutical intervention for 30days prior to and during the study
  • No over the counter medication for 48 hours prior to the study
  • Range of Motion measured using duel inclinometers, pre and post
  • Motor Strength testing (Hoppenfeld) of C-5 to T-1

The second, stricter study was completed January 2002. The results proved outstanding pain reduction, and increased muscle strength and range of motion. The overwhelming results were presented to the FDA in a 510(k) submission that led to the first low-level laser given market clearance by the FDA, awarded January 17, 2002. Not only did the Erchonia Medical studies garner the first low-level laser indication for use, the Erchonia laser device initiated the need for the FDA to create a new regulatory category, NHN Biostimulation lasers.

Erchonia Medical is proud to claim that because of our commitment to low-level laser technology and fortitude to prove our standing with clinical research, Low Level Lasers are a sanctioned medical modality.


Clinical Study 1

A Clinical Study of the Effectiveness for Mitigating Pain and Improving Range of Motion with the Erchonia Low-Level Laser on Minor Neck and Shoulder Pain: July-Sept 2000

*Erchonia Medical study submitted to the FDA and given market clearance January 2002.

Abstract

One hundred patients were recruited to participate in a randomized, double-blinded study of the temporary effects of the Erchonia low-level laser on ameliorating minor neck and shoulder pain and in improving range of motion. Individual subject-success criteria was defined as a 30% improvement in degree of pain from pre- to post-procedure measurement immediately following treatment. Forty out of the 50 test group subjects (90% of all test group subjects) met or exceeded the individual success criteria by demonstrating a 30% improvement in degree of pain rating from pre- to post-procedure measurement. Seven out of the 50 placebo group subjects (14% of all placebo group subjects) met or exceeded the individual success criteria by demonstrating a 30% improvement in degree of pain. Temporary improvements in pain levels for test patients were statistically significant at the p<0.05 level. Although not statistically significant, for the majority of patients, the reduction in degree of pain immediately after treatment by the laser was maintained or reduced further 24 hours post-treatment. Post-procedure linear range of motion measurements suggested significant improvements in range of motion for the right side of the neck and both right and left sides of shoulders. No adverse events were reported.

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. This landmark study helped the Erchonia Medical low level laser to become the first low level laser of any kind to be approved by the FDA.

Clinical Study 2

2001 Study on the Effectiveness of the Erchonia Low Level Laser in Providing Temporary Relief of Chronic Minor Neck or Shoulder Pain

*Erchonia Medical study submitted to the FDA and given market clearance January 2002.

Abstract

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.