The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Low Back Pain (MLSLASERlumb)
Non-specific Low Back Pain
About this trial
This is an interventional treatment trial for Non-specific Low Back Pain
Eligibility Criteria
Inclusion Criteria: Chronic low back pain (> 3 months) Lack of effectivness of previous conservative therapies for low back pain Body mass index < 30 Preserved cognitive ability to fully understand and observe indications received by medical personnel Ability to understand and give an informed consent Exclusion Criteria: Spine surgery Spinal hernia spondylolisthesis Spinal infections Severe spine deformities Neural diseases Rheumatic diseases Diabetes Psychiatric diseases Vascular diseases Cancer Infectious diseases Kidney stones Skin abrasion Pregnancy or breastfeeding Recent injuries Known sensibility to Laser therapy Epilepsy Anticoagulant therapy Pacemaker hemorrhagic diathesis Photosensitizing drugs Kown Photosensibility Low back Tattoos Steroid injections in the previous 3 weeks Antinflammatory or pain drugs HIV positive Neuro-stimulation implanted systems Tissue with ischemia in the low back
Sites / Locations
- IRCCS-Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Sham Comparator
Experimental
Sham laser therapy
Laser therapy
The control group (PL group) is subjected to a laser sham (placebo), employing a device identical to the one under investigation but lacking the laser emission capability, and the same mode of administration in terms of time and place. Both the sham laser and the test device emit visible light of the same color and are not distinguishable in any way.
The MLS group receives MLS synchronized diode laser therapy emitted by the MLS M8 robotic device (ASA, Italy). MLS M8 (ASA, Arcugnano, Italy), a Class IV (high-power) laser approved by the Food Drug Administration (FDA) and CE certified, characterized by a combined, synchronized two-wavelength (CPW) emission: a continuous emission with a wavelength of 808 nm and a pulsed emission at 905 nm. The duration of each session is 5 min 45 sec.seconds, delivering a total energy of 1500 J and an energy dose of 5 J/cm2, for an area of 300 cm2. The robotic device is placed in the lumbar area, oriented on the muscles erector spinae and quadratus lumborum. The target area set on the device is "lumbar area." The parameters set on the device are "Synchronized Emission of Continuous Pulsed Wave (CPW)," "intensity of 100%," "time of 5 minutes and 45 seconds," and "area of 1x300 cm2."