EVALUATION OF LOW-LEVEL LASER THERAPY AT 635nm FOR THE TREATMENT OF ACUTE AND CHRONIC NECK AND SHOULDER PAIN: A PLACEBO-CONTROLLED, RANDOMIZED STUDY
Low-Level Laser Therapy for the Treatment of Chronic Neck and Shoulder Pain
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 Corporation study submitted to the FDA and given market clearance January 2002.
Abstract
One hundred patients were recruited to participate in a randomized, double-blind 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 (80% 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 Corporation low level laser to become the first low level laser of any kind to be approved by the FDA.