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Laser Auriculotherapy for the Treatment of Low Back Pain
Sponsor: Marcelo Neubauer de Paula
Summary
Controlled, double-blind, randomized clinical trial Primary endpoint: To demonstrate the superiority of Laser French Auriculotherapy (AFL) in relieving pain in patients with low back pain after a single session. Primary outcome: The increase in pain tolerance will be assessed by Algometry of the affected muscles Secondary endpoints: To determine the duration of the analgesic effect of AFL. To determine the increase in pain tolerance through Algometry Secondary outcomes: The improvement in pain after treatment with daily measurements for 7 days will be assessed using the TotPar Scale The reduction in pain will be assessed using the Sum of Pain Intensity Difference (SPID) Scale by comparing the differences in scores observed between pre-treatment and post-treatment with daily measurements for 7 days Reduction in the 10-point visual analogue scale for pain. Need for rescue medication Safety endpoint: Evaluate adverse events that occurred during the trial, after signing the Informed Consent Form (ICF). Safety outcomes: Evaluate safety through data obtained in clinical and physical assessments, and in specific assessments of the clinical trial (immediately after signing the ICF). Evaluate the rate of occurrence of non-serious and serious adverse events, related and unrelated to the treatment groups throughout the clinical trial.
Official title: Controlled, Double-blind, Randomized Clinical Trial of the Use of Laser Auriculotherapy for the Treatment of Low Back Pain
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2025-06-15
Completion Date
2027-07-01
Last Updated
2025-06-15
Healthy Volunteers
No
Conditions
Interventions
Laser Auriculotherapy
French Laser Auriculotherapy using the ECCO REABILITY device and dual pen with red laser with 660 nm wavelength, both manufactured by Ecco Optical Fibers and Devices, using the ideal Nogier Frequency for each region with application of 2 J per point with 100 mW power. For the active group, a 120 mW active tip, red laser with 660 nm, pulse width of 1.2 milliseconds will be used.