Chronic Knee PainNCT07010627
Chronic Pain Treatment Whith Auricular Laserpuncture
A study testing Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light and "Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds." in people with Chronic Knee Pain and Chronic Shoulder Pain, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Chronic Knee Pain, Chronic Shoulder Pain, Chronic Low Back Pain
- What is being tested?
- Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light and "Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds."
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 20 May 2025to 1 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 60 to 90 years;
- Both sexes;
- Chronic pain in the lumbar region, shoulder, or knee;
- Signed the Informed Consent Form.
Who cannot join
- Undergoing treatment similar to the proposed research protocol at another facility or physiotherapy service;
- Inability to fully understand the protocol proposed by the researcher;
- Unwillingness to participate in the study and/or inability to attend all proposed treatment sessions;
- Presence of lesions on the auricular pavilion;
- Presence of earrings or piercings in the auricular acupoint regions targeted for treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
UNIVAP- University of Paraiba Valley
São José dos Campos, São Paulo, 12244-390
About this study
Official title: Evaluation of the Application of Auricular Laserpuncture in the Treatment of Chronic Pain
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.
Read the detailed description
This study analyzed the effectiveness of treatment protocols A and B for chronic pain in the shoulder, knee, or lumbar spine regions in older adults. Protocol A involved the application of low-power red laser therapy to auriculotherapy acupoints. Protocol B involved the application of mustard seeds. To assess the qualitative aspect of the study, the McGill Pain Questionnaire and the Visual Analog Scale were used to evaluate chronic pain, while the SF-36 instrument assessed the participants' quality of life before and after the treatment protocol. For the quantitative evaluation, thermographic imaging and the Ryodoraku System were used. All proposed tools were 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 were subject to risks related to physical and psychological discomfort due to the proposed therapeutic protocol. All procedures were performed individually in an appropriate and private room to ensure the participants' comfort and privacy. Each participant was provided with protective goggles, which were worn throughout the laser application period. These goggles were sanitized before each session, and the laser device tip was covered with PVC film, which was replaced after each session.
Although rare, stimulation of the auricular pavilion could cause transient side effects such as local pain, fatigue, dizziness, nausea, and headaches. The use of the laser could generate slight discomfort, such as mild warming, but this effect was temporary and had no serious consequences. If a participant experienced any of these symptoms or any other physical discomfort, the protocol was immediately interrupted, and the participant remained under observation by the researcher until they felt better. The use of mustard seeds could cause mild pain at the application site, but this typically subsided over time. Participants were informed that if a seed fell off prematurely, it would 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 could also arise when participants answered the questionnaires. The questionnaires were administered in a private setting with only the participant and the researcher present. If the participant felt uncomfortable, they could request to withdraw from the study.
To minimize the risk of exposure of participants' personal data, the researcher committed to storing all collected data in password-protected digital files accessible only to the research team. Each participant was assigned an individual identification code to prevent any possibility of unauthorized access or identification.
Whenever the participant wished, the principal researcher provided clarifications regarding the procedures to establish trust. Participants were informed that they could withdraw from the study at any time without affecting the continuity of their treatment.
As a benefit of this study, the results were expected to help establish a non-invasive, easy-to-apply, and ergonomically comfortable treatment protocol for chronic pain in older adults, thereby improving their quality of life.
Clinical Protocol
The participants were received individually in a private room with only the researcher present. They were instructed to sit comfortably in a chair. The McGill Pain Questionnaire, the SF-36 questionnaire, and the Visual Analog Scale for Pain were then administered to assess pain intensity and its impact on the participants' quality of life.
After completing the questionnaires, while still seated, the researcher evaluated the participants using the Ryodoraku System for bioenergetic meridian measurement. This assessment was 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 was held by the participant, while the researcher manipulated the other, placing it in direct contact with the acupoints. The device was connected via USB to a computer with pre-installed software, generating graphs that compared the participants' meridian conditions and possible energy imbalances with a standard balanced energy pattern.
Next, thermographic images of the area where the participant experienced chronic pain were taken using a thermal imaging camera. During this process, participants stood upright on an insulated rubber surface. The analyzed region was free of clothing. Images were captured from a distance of 50 cm from the target area to ensure proper framing, against a black background to avoid infrared radiation reflection. Participants were 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 were 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 (MM Optics) was used. The device was operated with red laser light at a wavelength of 660 nm, an output power of 100 mW, a beam area of 0.03 cm², and continuous emission. An energy of 4 J was delivered to each auricular point over 40 seconds per point. All participants sat in a comfortable position and wore protective goggles provided by the researcher, who also wore protective goggles during laser application.
For participants in Group B, mustard seeds were applied with micropore tape to the same auriculotherapy acupoints used in Group A. Each participant underwent ten sessions, twice a week, over five weeks of treatment.
For participants with shoulder or knee pain, the auriculotherapy acupoints were treated on the ear corresponding to the side of the reported pain. For participants with low back pain, the right ear was treated. These points were previously cleaned with gauze soaked in 70% alcohol. Additionally, the laser device tip was wrapped in PVC film, which was replaced for each participant.
- Being tested
- 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."
- Keywords
- chronic pain, elderly, auricular laserpuncture, auriculotherapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red lightProcedure or surgery
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).
"Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds."Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Auriculotherapy for chronic pain treatment with laser stimulation of acupoints using red light | Active comparator | 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. Receives: 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." | Active comparator | 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. Receives: Procedure: "Auriculotherapy for chronic pain treatment with stimulation of acupoints using mustard seeds." |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (before the first treatment session) to the end of treatment after the tenth session, approximately 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start20 May 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The participants allocated to both groups (n=30/group) underwent ten treatment sessions, twice weekly for five weeks. Group A received auricular laser acupuncture using continuous red laser light at 660 nm, with 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. Group B received auricular seed acupressure using mustard seeds applied to the same auricular acupoints used in Group A. Participants were instructed to press the seeds three times a day and remove them one day before the next treatment session. The auricular acupoints were selected according to the region of chronic pain (shoulder, knee, or lumbar spine).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Brazil
- Responsible party
- Sponsor
- Investigators
- Luís Eduardo S soares, co-advisor doctoral, Study director, UNIVAP- University of Paraiba ValleyEmilia Angela A arisawa, advisor doctoral, Study director, UNIVAP- University of Paraiba ValleyGerson Q Jr, Doctoral Student, Principal investigator, UNIVAP- University of Paraiba Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010627
- Sponsor's protocol ID
- 78513124.1.0000.5503
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.