Clinical trial NCT07010627: Chronic Pain Treatment Whith Auricular Laserpuncture
Official title: Evaluation of the Application of Auricular Laserpuncture in the Treatment of Chronic Pain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Knee Pain
Chronic Shoulder Pain
Chronic Low Back Pain
Keywords: chronic pain
elderly
auricular laserpuncture
auriculotherapy
Lead sponsor: Universidade do Vale do Paraíba
Sponsor class: OTHER
Collaborators: name: CAPES Foundation - Ministry of Education, Brazil.
First posted: 2025-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: This study will analyze the effectiveness of treatment protocols A or B for chronic pain in the shoulder, knee, or lumbar spine regions in elderly individuals. The protocol A involves the application of low-power red laser therapy on auriculotherapy acupoints. The protocol B involves the application of mustard seeds . To assess the qualitative aspect of the study, the McGill Pain Questionnaire and the Visual Analog Scale will be used to evaluate chronic pain, while the SF-36 instrument will assess the participants' quality of life before and after the treatment protocol. For the quantitative evaluation, thermographic imaging and the Ryodoraku System will be used. All proposed tools will be applied before the first treatment session, before the fifth session ,and at the end of the tenth session.

Risks and Benefits During the study, participants will be subject to risks related to physical and psychological discomfort due to the proposed therapeutic protocol. All procedures will be performed individually in an appropriate and private room to ensure the participant's comfort and privacy. Each participant will be provided with protective goggles, which must be worn throughout the laser application period. These goggles will be sanitized before each session, and the laser device tip will be covered with PVC film, replaced after each session.

Although rare, stimulation of the auricular pavilion may cause transient side effects such as local pain, fatigue, dizziness, nausea, and headaches. The use of the laser may generate slight discomfort, such as mild warming, but this effect is temporary and has no serious consequences. If a participant experiences any of these symptoms or any other physical discomfort, the protocol will be immediately interrupted, and the participant will remain under observation by the researcher until they feel better. The use of mustard seeds may cause mild pain at the application site, but this typically subsides over time. Participants will be informed that if a seed falls off prematurely, it will not affect the treatment, and they should continue stimulating the remaining seeds three times a day and remove them one day before the next session.

Psychological discomfort may also arise when participants answer the questionnaires. The questionnaire will be administered in a private setting with only the participant and the researcher present. If the participant feels uncomfortable, they may request to withdraw from the study.

To minimize the risk of exposure of participants' personal data, the researcher commits to storing all collected data in password-protected digital files accessible only to the research team. Each participant will be assigned an individual identification code to prevent any possibility of access or identification.

Whenever the participant wishes, the principal researcher will provide clarifications regarding the procedures to establish trust. Participants will be informed that they may withdraw from the study at any time without affecting the continuity of their treatment.

As a benefit of this study, the results are expected to help establish a non-invasive, easy-to-apply, and ergonomically comfortable treatment protocol for chronic pain in elderly individuals, thereby improving their quality of life.

Clinical Protocol The participant will be received in a private room with only the researcher present. They will be instructed to sit in a chair comfortably. The McGill Pain Questionnaire, the SF-36 questionnaire, and the Visual Analog Scale for Pain will then be administered to assess the intensity of pain and its impact on the participant's quality of life.

After completing the questionnaires, while still seated, the researcher will evaluate the participant using the Ryodoraku System for bioenergetic meridian measurement. This assessment will be conducted through 24 reactive points, known as electro-permeable skin points , located on the upper and lower limbs at the acupoints P9, PC7, C7, ID5, TA4, IG5, BP3, F3, R4, B65, VB40, and E42. The Ryodoraku System is a portable electronic device equipped with two wand-shaped electrodes. One wand will be held by the participant, while the researcher manipulates the other, placing it in direct contact with the acupoints. The device is connected via USB to a computer with pre-installed software, generating graphs that compare the participants' meridian conditions and possible energy imbalances with a standard balanced energy pattern.

Next, thermographic images of the area where the participant experiences chronic pain will be taken using a thermal imaging camera. During this process, participants will stand upright on an insulated rubber surface. The analyzed region must be free of clothing. Images will be captured from a distance of 100 cm from the target area to ensure proper framing, against a black background to avoid infrared radiation reflection. Participants will be instructed to avoid alcohol, physical exercise, bathing, and stimulant intake (such as caffeine) for at least two hours before the examination.

The evaluation tools for research data collection will be applied before the first session , before the fifth session , and after the tenth session .

Treatment Protocol For participants in Group A (GA), a portable Recover laser device (MMO, with LI-Ion 7.4V/650 mA battery, ) will be used. This device emits visible and invisible laser radiation, with a diode laser λ=600 nm/808 nm, P=100mW (each laser), , programmed in continuous mode with red light emission at 4 J power. All participants will sit in a comfortable position and wear protective goggles provided by the researcher (who will also wear goggles during laser application).

For participants in Group B , mustard seeds will be applied with micropore tape to the same auriculotherapy acupoints used in group A. Each participant will undergo ten sessions, twice a week, over five weeks of treatment.

The auriculotherapy acupoints will be located in the right auricular pavilion for all participants. These points will be previously cleaned with gauze soaked in 70% alcohol. Additionally, the laser device tip will be wrapped in PVC film, which will be replaced for each participant.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Comparative efficacy evaluation between the application of auricular laser acupuncture and the use of mustard seeds in the treatment of chronic pain
timeFrame: Untill the completion of the study which take approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: UNIVAP- University of Paraiba Valley
state: São Paulo
Study officials:
affiliation: UNIVAP- University of Paraiba Valley
name: Luís Eduardo S soares, co-advisor doctoral
role: STUDY_DIRECTOR
affiliation: UNIVAP- University of Paraiba Valley
name: Emilia Angela A arisawa, advisor doctoral
role: STUDY_DIRECTOR
affiliation: UNIVAP- University of Paraiba Valley
name: Gerson Q Quadros Jr, Doctoral Student
role: PRINCIPAL_INVESTIGATOR
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