NCT07010627|CompletedDMC
Chronic Pain Treatment Whith Auricular Laserpuncture
Evaluation of the Application of Auricular Laserpuncture in the Treatment of Chronic Pain
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Evaluation of the Application of Auricular Laserpuncture in the Treatment of Chronic Pain
Sponsor study identifier
interventional
60
1 country
1
Study Start
May 20, 2025
Actual (reported)Primary Completion
December 1, 2025
Actual (reported)Study Completion
December 1, 2025
Actual (reported)The objective of the study is to evaluate the effectiveness of a treatment protocol using auricular acupuncture point stimulation with laser, compared with the use of mustard seeds, for reducing chronic pain in older adults. With this research, the researchers hope to obtain results that will allow the establishment of a non-invasive, easy-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. At the first session, before the start of the treatment protocol, three questionnaires will be administered: the SF-36 to assess quality of life, the Visual Analog Scale for pain intensity, and the McGill Pain Questionnaire. The pain region will also be assessed using a thermographic camera to evaluate skin temperature and the Ryodoraku System. The same evaluation protocol will be repeated before the fifth session and after the tenth session.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2025
Actual (reported)May 20, 2025
Actual (reported)June 8, 2025
Actual (reported)December 1, 2025
Actual (reported)December 1, 2025
Actual (reported)Comparative efficacy evaluation between the application of auricular laser acupuncture and the use of mustard seeds in the treatment of chronic pain
Data were analyzed using linear mixed-effects models. Each outcome was modeled as a function of MOMENT (A1, A2, and A3), GROUP (Laser and Seed), and the MOMENT × GROUP interaction, with a random intercept for participant. Models were estimated using restricted maximum likelihood (REML), with Satterthwaite approximation for degrees of freedom. Statistical significance was set at p \< 0.05. When significant omnibus effects were identified, estimated marginal means were compared using Bonferroni-adjusted post hoc tests.
From baseline (before the first treatment session) to the end of treatment after the tenth session, approximately 5 weeks.
Stimulation using a laser operating in continuous mode, with red light at a wavelength of 660 nm, an output power of 100 mW, and a beam area of 0.03 cm². An energy of 4 J was delivered to each auricular acupoint over 40 seconds per point: 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.
The conventional clinical practice treatment was carried out using 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. Participants were instructed to press the seeds three times a day and to remove them one day before the next treatment session.
This arm of the study analyzed the effectiveness of the treatment protocol for chronic pain in the shoulder, knee, or lumbar spine regions in older adults, using auricular acupuncture with low-power red laser stimulation applied to auriculotherapy acupoints. For the qualitative evaluation of the study, the McGill Pain Questionnaire (Annex A) and the Visual Analog Scale (Annex B) were used to assess chronic pain, while the SF-36 instrument (Annex C) was used to assess participants' quality of life before and after the treatment protocol. For the quantitative evaluation, thermographic imaging and the Ryodoraku System were used. All proposed assessment tools were applied before the first treatment session (A1), before the fifth session (A2), and after the tenth session (A3).
UNIVAP- University of Paraiba Valley
São José dos Campos, São Paulo, 12244-390, Brazil
Luís Eduardo S soares, co-advisor doctoral
UNIVAP- University of Paraiba Valley
Emilia Angela A arisawa, advisor doctoral
UNIVAP- University of Paraiba Valley
Gerson Q Jr, Doctoral Student
UNIVAP- University of Paraiba Valley
60 participants (actual enrollment reported by the registry).
First Submitted
April 23, 2025
Auricular Vagus Nerve Stimulation in Patients With High Impact Chronic Low Back Pain
McKenzie vs Pilates Exercises in People With Chronic Low Back Pain
This arm of the study analyzed the effectiveness of the treatment protocol for chronic pain in the shoulder, knee, or lumbar spine regions in older adults, using mustard seeds applied to auriculotherapy acupoints. For the qualitative evaluation of the study, the McGill Pain Questionnaire (Annex A) and the Visual Analog Scale (Annex B) were used to assess chronic pain, while the SF-36 instrument (Annex C) was used to assess participants' quality of life before and after the treatment protocol. For the quantitative evaluation, thermographic imaging and the Ryodoraku System were used. All proposed assessment tools were applied before the first treatment session (A1), before the fifth session (A2), and after the tenth session (A3).
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First Posted
June 8, 2025
Study Start
May 20, 2025
Actual (reported)Primary Completion
December 1, 2025
Actual (reported)Study Completion
December 1, 2025
Actual (reported)Last Updated
October 6, 2026
Record last verified: 2026-10
Description of the IPD to be Shared: All individual participant data (IPD) collected during the study, including de-identified demographic data, clinical outcomes (pain scores, quality of life assessments), Ryodoraku measurements, and thermographic imaging data. What data will be shared: All IPD underlying the results of the published primary and secondary outcome measures.
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Source: ClinicalTrials.gov.
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