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Laser Auriculotherapy for the Treatment of Low Back Pain

NCT07021768 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Hospital das Clínicas, University of Sao Paulo Medical School

    collaborator UNKNOWN

  • Marcelo Neubauer de Paula

    lead OTHER

Principal Investigators

  • Marcelo N de Paula, PHD Student · Faculty of Medicine of the University of São Paulo

  • Wu T Hsing, PHD · Faculty of Medicine of the University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2026-12-31
Completion
2027-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021768 on ClinicalTrials.gov