Laser Auriculotherapy for the Treatment of Low Back Pain

NCT07021768 | Not Yet Recruiting

• 1 other identifier: 87524325.0.0000.0068
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Laser; Auriculotherapy; Low Back Pain; Nogier; French Auriculotherapy

Outcome Measures

Primary Outcomes (1)

• Algometry

  Increase in pain tolerance will be assessed by Algometry of the affected muscles

  1 hour after intervention

Secondary Outcomes (5)

• TotPar Scale

  1 week after intervention

• SPID Scale

  1 week after intervention

• Visual analogue scale

  1 week after intervention

• Rescue medication

  1 week after intervention

• Adverse Events

  1 week after intervention

Study Arms (2)

Laser auriculotherapy

EXPERIMENTAL

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.

Device: Laser Auriculotherapy

Placebo auriculotherapy

PLACEBO COMPARATOR

Placebo laser through the ECCO REABILITY device and sham pen both manufactured by Ecco Optical Fibers and Devices. For the control group, a placebo tip with a 660 nm red laser with 1 mW of power and a pulse width of 1.2 milliseconds will be used.

Device: Laser Auriculotherapy

Interventions

Laser Auriculotherapy DEVICE

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.

Also known as: Photobiomodulation

Laser auriculotherapy; Placebo auriculotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant capable of understanding and performing all procedures and instructions described in the Informed Consent Form approved by the Research Ethics Committee;
• Participants of both sexes, aged between 18 and 65 years (inclusive);
• Participants diagnosed with low back pain who are in pain at the time of the assessment

You may not qualify if:

• Any clinical observation finding (clinical/physical evaluation) that is interpreted by the investigating physician as a risk to participation in the clinical trial;
• Patient with a deforming lesion on the ear
• Patient with a tattoo covering any of the points selected for treatment
• Patients using ear expanders on the side to be treated
• Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Brazilian National Health Council Resolution 251, of August 7, 1997), unless the investigator believes that there may be direct benefit to the same.

Sponsors & Collaborators

• Marcelo Neubauer de Paula: lead
• Hospital das Clínicas, University of Sao Paulo Medical School: collaborator

MeSH Terms

Conditions

Low Back Pain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Marcelo N de Paula, PHD Student

  Faculty of Medicine of the University of São Paulo

  PRINCIPAL INVESTIGATOR

• Wu T Hsing, PHD

  Faculty of Medicine of the University of São Paulo

  STUDY CHAIR

Central Study Contacts

Marcelo N de Paula, PHD student

CONTACT

+ 55 11 98950 5447; keptah3@gmail.com

Wu T Hsing, Medical Director

CONTACT

+ 55 11 98199 8157; wu@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The procedure will be performed by an unblinded investigator. The patient will be blinded by means of an eye shield that blocks his/her vision. The assessment of pain scales and algometry will be performed by a blinded investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guest Professor at the IOTHCFMUSP Acupuncture Center

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 15, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: For 12 months after the study is published
• Access Criteria: Members of the board of the journal to which the study was submitted, members of the doctoral defense committee, research ethics committee, members of the board of directors of the institution where the study will be carried out