Chronic Pain Treatment Whith Auricular Laserpuncture

NCT07010627 | Enrolling By Invitation DMC

• 1 other identifier: 78513124.1.0000.5503
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study to evaluate the effectiveness of a treatment protocol using auricular acupuncture point stimulation with laser , compared to the use of mustard seeds, for reducing chronic pain in the elderly. With this research, the researches hope to obtain results that allow us to establish a non-invasive, easy, quick-to-apply, and painless treatment protocol to minimize chronic pain in the lumbar spine, shoulders, and knees, thereby improving the quality of life of the target population in this study. In the first session and before the start of the treatment protocol, three questionnaires will be applied for evaluation of the subjects: the first to assess quality of life (SF-36), and the others to evaluate pain intensity (Visual Analog Scale for pain and the McGill Pain Questionnaire). The pain location will be assessed using a thermografic camara that evaluates skin temperature, as well as a Traditional Chinese Medicine device (Ryodoraku) that measures the energy flow in the body's meridians. The same evaluation protocol will be repeated before the fifth session and after the tenth session.

Conditions

Chronic Knee Pain; Chronic Shoulder Pain; Chronic Low Back Pain

Keywords

chronic pain; elderly; auricular laserpuncture; auriculotherapy

Outcome Measures

Primary Outcomes (1)

• Comparative efficacy evaluation between the application of auricular laser acupuncture and the use of mustard seeds in the treatment of chronic pain

  The collected data will be entered and tabulated in Excel 2010 and analyzed using the Statistical Package for the Social Sciences (SPSS), version 17.0. The Shapiro-Wilk test will be performed on numerical variables to determine whether they follow a normal distribution. A significance level of 0.05 will be adopted to assess normality. For normally distributed data, Pearson's correlation coefficient (r) will be used to measure the magnitude and degree of relationship between variables, and Student's t-test will be applied to evaluate significant differences between the means of two conditions.

  Untill the completion of the study which take approximately 12 months

Study Arms (2)

Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light

"Stimulation using a laser programmed in continuous mode, emitting red light (4 J of energy) at the following auricular acupoints: 1. Chronic shoulder pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, shoulder region, adrenal; 2. Chronic knee pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, knee region, adrenal; 3. Chronic lumbar pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, lumbar region, adrenal."

Procedure: Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light

"Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds."

The conventional clinical practice treatment will be carried out, consisting of the application of mustard seeds to stimulate the following auricular acupoints: 1. Chronic shoulder pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, shoulder region, adrenal; 2. Chronic knee pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, knee region, adrenal; 3. Chronic lumbar pain: shen men, kidneys, peripheral nervous system, analgesia, muscle relaxation, lumbar region, adrenal.

Procedure: "Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds."

Interventions

Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light PROCEDURE

This arm of the study will analyze the effectiveness of the treatment protocol for chronic pain in the shoulder, knee, or lumbar spine region in elderly individuals, using the application of laser acupuncture with low-power laser and red light on acupoints of Auriculotherapy. As a criterion for the qualitative evaluation of the study, the McGill questionnaires (Annex A) and the Visual Analog Scale (Annex B) will be used to assess chronic pain, while the SF-36 instrument (Annex C) will allow for the evaluation of participants' quality of life before and after the treatment protocol. For quantitative evaluation, thermographic images and the Ryodoraku System will be used. All proposed tools will be applied before the first treatment session (A1), before the fifth session (A2), and at the end of the tenth session (A3).

Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light

"Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds." PROCEDURE

This arm of the study will analyze the effectiveness of the treatment protocol for chronic pain in the shoulder, knee, or lumbar spine regions in elderly individuals, utilizing the application of mustard seeds on Auriculotherapy acupoints. As criteria for the qualitative evaluation of the study, the McGill questionnaires (Annex A) and the Visual Analog Scale (Annex B) will be used to assess chronic pain, while the SF-36 instrument (Annex C) will allow for the evaluation of participants' quality of life before and after the treatment protocol. For quantitative evaluation, thermographic images and the Ryodoraku System will be utilized. All proposed tools will be applied before the first treatment session (A1), before the fifth session (A2), and at the end of the tenth session (A3)

"Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds."

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Initially, in order to recruit participants for this study, invitation flyers will be displayed at the Castejon Campus, home to the Faculty of the Third Age, and at the Urbanova Campus, home to the Faculty of Health Sciences (FCS), both part of the University of Vale do Paraíba (UNIVAP), located in São José dos Campos, Brazil.

You may qualify if:

• Participants aged between 60 and 90 years;
• Both sexes;
• Report of chronic pain in the lumbar region, shoulders, or knees;
• Sign the Informed Consent Form.

You may not qualify if:

• Undergoing treatment similar to the proposed research protocol at another facility or physiotherapy service;
• Using analgesic or anti-inflammatory medications;
• Unable to fully understand the protocol proposed by the researcher;
• Unwilling to participate in the study and/or unavailable to attend all proposed treatment sessions;
• Presence of lesions on the auricular pavilion;
• Wearing earrings or piercings in the acupoint regions targeted for laser stimulation.

Sponsors & Collaborators

• Universidade do Vale do Paraíba: lead
• Ministry of Education, Brazil: collaborator

Study Sites (1)

UNIVAP- University of Paraiba Valley

São José dos Campos, São Paulo, 12244-390, Brazil

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Auriculotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Luís Eduardo S soares, co-advisor doctoral

  UNIVAP- University of Paraiba Valley

  STUDY DIRECTOR

• Emilia Angela A arisawa, advisor doctoral

  UNIVAP- University of Paraiba Valley

  STUDY DIRECTOR

• Gerson Q Quadros Jr, Doctoral Student

  UNIVAP- University of Paraiba Valley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: June 8, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: When will the data be available: 6 months after the publication of the main results. How long will the data be available: The data will be available for 5 years after the initial publication.
• Access Criteria: Qualified researchers who submit a methodologically sound proposal for secondary analyses.

Locations

BR (1)