Low Back PainLaserNCT07021768
Laser Auriculotherapy for the Treatment of Low Back Pain
A study testing Laser Auriculotherapy in people with Low Back Pain, run by Marcelo Neubauer de Paula.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Laser Auriculotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Controlled, Double-blind, Randomized Clinical Trial of the Use of Laser Auriculotherapy for the Treatment of Low Back Pain
Controlled, double-blind, randomized clinical trial
Primary endpoint:
Read more
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.
Read the detailed description
Trial Population Patients with primary or secondary low back pain, aged between 18 and 65 years, who attended the Institute of Orthopedics and Traumatology of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (IOTHCFMUSP) acupuncture clinic.
Trial Design
Clinical, superiority, double-blind, randomized trial with two parallel groups:
- Test Group: Will receive an auricular laser application at the points indicated for this treatment and that are active (through a point locator device) using a 660 nanometer red laser with the appropriate Nogier frequency, 2 joules per point. In addition, an infrared laser will be applied at the frequency
- Comparator group: will receive a touch on the skin at the same points with a non-laser emitting pen.
Both patients will wear opaque protective glasses and, therefore, will not be able to observe the application. The patient must continue to use the prescribed medications.
Experimental procedure:
Laser French Auriculotherapy using the ECCO REABILITY device and dual pen with red laser with a wavelength of 660 nm, manufactured by Ecco Fiber Optics and Devices, using the ideal Nogier Frequency for each region, with the application of 2 J per point and a power of 100 mW. For the active group, a 120 mW active tip, red laser with 660 nm, pulse width of 1.2 milliseconds will be used.
Comparator procedure:
Placebo laser using the ECCO REABILITY device and sham pen, both manufactured by Ecco Fiber Optics and Devices. For the control group, a placebo tip with red laser 660 nm with 1 mW of power, pulse width of 1.2 milliseconds will be used.
Application method Single session. The auriculotherapy treatment protocol will be adapted according to each patient. The Nogier mapping will be applied: lumbar and sacral spine area; Lumbar muscles in the posterior wall, thalamus, zero, zero', Shen Men and prefrontal cortex, main sensory and master point of the spine, in addition to the radian technique using the corresponding point in the auricular helix. The points to be used must be active according to the EL30 Finder differential pen point locator device manufactured by NKL Medical DevicesL.
A red laser with a wavelength of 660 nm will be used with the ideal frequency for each location (Nogier frequencies) with an intensity of 2 joules per point. Patients randomized to the placebo group will undergo the same procedures, however a placebo pen will be used.
If the pain is located on one side, the application will be made in the ear on the same side as the affected side. If the pain is bilateral, the application will be made in both ears. If the pain only affects the midline, the application will be made in the ear on the same side as the dominant hand.
Methodology Blinding The procedure will be performed by an unblinded investigator. The patient will be blinded by means of an eye protector that blocks his/her vision. The assessment of pain scales and algometry will be performed by a blinded investigator.
There will be 11 visits in total Visit 0 (V0) - Initial visit
- Participant clarification about the protocol
- Signing of the informed consent form
- Assessment of the inclusion and exclusion criteria;
- Randomization of the research participant; This visit will be performed by an unblinded investigator
Visit 1 (V1) - Screening visit
After the participant consents to participate in the trial, the following procedures must be performed:
- Collect demographic data;
- Assess and record medical history;
- Perform a complete physical examination;
- Record previous medications used in the last two weeks;
- Apply the initial scales
- Test algometry on the muscles affected by pain. This visit will be performed by a blinded investigator
Visit 2 (V2) - Randomization and treatment visit • Apply the experimental or sham treatment according to randomization This visit will be performed by an unblinded investigator
Visit 3 (V3) - Reassessment visit
- Reapply the TotPar and SPID scale and repeat algometry This visit will be performed by a blinded investigator
Visit 4 (V4) - Telephone reassessment visit
- After 24h of V3
- Reapply the TotPar and SPID scale This visit will be performed by a blinded investigator
Visit 5 (V5) - Telephone reassessment visit
- After 24h of V4
- Reapply the TotPar and SPID scale This visit will be performed by a blinded investigator
Visit 6 (V6) - Telephone reassessment visit
- After 24h of V5
- Reapply the TotPar and SPID scale SPID This visit will be conducted by a blinded investigator
Visit 7 (V7) - Telephone reassessment visit
- After 24h from V6
- Reapply the TotPar and SPID scale This visit will be conducted by a blinded investigator
Visit 8 (V8) - Telephone reassessment visit
- After 24h from V7
- Reapply the TotPar and SPID scale This visit will be conducted by a blinded investigator
Visit 9 (V9) - Telephone reassessment visit
- After 24h from V8
- Reapply the TotPar and SPID scale This visit will be conducted by a blinded investigator
Visit 10 (V10) - Closing visit
- After 24h from V9
- Reapply the TotPar and SPID scale
- Final reassessment
- Referral for follow-up This visit will be conducted by a blinded investigator.
Statistical Plan The outcome is of an ordinal qualitative nature and, therefore, the one-tailed non-parametric Mann-Whitney-Wilcoxon test will be used to verify whether laser is superior to sham acupuncture in reducing pain.
The outcome is of an ordinal qualitative nature and, therefore, the Fischer test will be used to verify whether laser is superior to sham acupuncture in reducing pain. The sample size calculation was performed using the G*Power software, considering that the statistical analysis will be performed using the Fisher test:
- Fisher's Exact Test
- One-tailed Hypothesis Test
- Two independent groups
- Options: Exact distribution
- Input: Tail(s) = One
- Proportion p1 = 0.8
- Proportion p2 = 0.5
- Significance Level (α error) = 0.05
- Power (1-β error) = 0.95
- Allocation ratio N2/N1 = 1
- Output: Sample size group Active Laser Group = 59
- Sample size group Placebo Group = 59
- Total sample size = 118
- Real power = 0.9521908
- Real α = 0.0399172 Randomization will be stratified by gender and the sequence will be generated by the SEALED ENVELOPE portal available at https://www.sealedenvelope.com/.
Blinding The study will be double-blind, with the participation of a blinded investigator and an unblinded investigator.
Source of Patients for the study Patients who were referred to the outpatient clinic of the Acupuncture Center of the IOTHCFMUSP.
- Conditions
- Low Back Pain
- Being tested
- Laser Auriculotherapy
- Keywords
- Laser, Auriculotherapy, Low Back Pain, Nogier, French Auriculotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AuriculotherapyDevice
Also called Photobiomodulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Laser Auriculotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometry
Increase in pain tolerance will be assessed by Algometry of the affected muscles
Measured: 1 hour after intervention
Secondary outcomes (5)
TotPar Scale
The improvement in pain after treatment with daily measurements for 7 days will be assessed using the TotPar Scale.
Measured: 1 week after intervention
SPID Scale
The reduction in pain will be assessed using the SPID Scale by comparing the differences in scores observed between pre-treatment and post-treatment with daily measurements for 7 days.
Measured: 1 week after intervention
Visual analogue scale
Reduction in the 10-point visual analogue scale for pain.
Measured: 1 week after intervention
Rescue medication
Need for rescue medication
Measured: 1 week after intervention
Adverse Events
Assess the rate of occurrence of non-serious and serious adverse events, related and unrelated to the treatment groups, throughout the clinical trial.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcelo Neubauer de Paula
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Sponsor-investigator, Marcelo Neubauer de Paula, University of Sao Paulo
- Investigators
- Marcelo N de Paula, PHD Student, Principal investigator, Faculty of Medicine of the University of São PauloWu T Hsing, PHD, Study chair, Faculty of Medicine of the University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021768
- Sponsor's protocol ID
- 87524325.0.0000.0068
- Acronym
- Laser
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Initially the data will be anonymized and will be available for possible auditing.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Double-blind, Randomized Clinical Trial of the Use of Laser Auriculotherapy for the Treatment of Low Back Pain
- ClinicalTrials.gov ID
- NCT07021768
- Acronym / sponsor ID
- Laser / 87524325.0.0000.0068
- Conditions
- Low Back Pain
- Keywords
- Laser, Auriculotherapy, Low Back Pain, Nogier, French Auriculotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Marcelo Neubauer de PaulaUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trial Population Patients with primary or secondary low back pain, aged between 18 and 65 years, who attended the Institute of Orthopedics and Traumatology of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (IOTHCFMUSP) acupuncture clinic.
Trial Design
Clinical, superiority, double-blind, randomized trial with two parallel groups:
- Test Group: Will receive an auricular laser application at the points indicated for this treatment and that are active (through a point locator device) using a 660 nanometer red laser with the appropriate Nogier frequency, 2 joules per point. In addition, an infrared laser will be applied at the frequency
- Comparator group: will receive a touch on the skin at the same points with a non-laser emitting pen.
Both patients will wear opaque protective glasses and, therefore, will not be able to observe the application. The patient must continue to use the prescribed medications.
Experimental procedure:
Laser French Auriculotherapy using the ECCO REABILITY device and dual pen with red laser with a wavelength of 660 nm, manufactured by Ecco Fiber Optics and Devices, using the ideal Nogier Frequency for each region, with the application of 2 J per point and a power of 100 mW. For the active group, a 120 mW active tip, red laser with 660 nm, pulse width of 1.2 milliseconds will be used.
Comparator procedure:
Placebo laser using the ECCO REABILITY device and sham pen, both manufactured by Ecco Fiber Optics and Devices. For the control group, a placebo tip with red laser 660 nm with 1 mW of power, pulse width of 1.2 milliseconds will be used.
Application method Single session. The auriculotherapy treatment protocol will be adapted according to each patient. The Nogier mapping will be applied: lumbar and sacral spine area; Lumbar muscles in the posterior wall, thalamus, zero, zero', Shen Men and prefrontal cortex, main sensory and master point of the spine, in addition to the radian technique using the corresponding point in the auricular helix. The points to be used must be active according to the EL30 Finder differential pen point locator device manufactured by NKL Medical DevicesL.
A red laser with a wavelength of 660 nm will be used with the ideal frequency for each location (Nogier frequencies) with an intensity of 2 joules per point. Patients randomized to the placebo group will undergo the same procedures, however a placebo pen will be used.
If the pain is located on one side, the application will be made in the ear on the same side as the affected side. If the pain is bilateral, the application will be made in both ears. If the pain only affects the midline, the application will be made in the ear on the same side as the dominant hand.
Methodology Blinding The procedure will be performed by an unblinded investigator. The patient will be blinded by means of an eye protector that blocks his/her vision. The assessment of pain scales and algometry will be performed by a blinded investigator.
There will be 11 visits in total Visit 0 (V0) - Initial visit
- Participant clarification about the protocol
- Signing of the informed consent form
- Assessment of the inclusion and exclusion criteria;
- Randomization of the research participant; This visit will be performed by an unblinded investigator
Visit 1 (V1) - Screening visit
After the participant consents to participate in the trial, the following procedures must be performed:
- Collect demographic data;
- Assess and record medical history;
- Perform a complete physical examination;
- Record previous medications used in the last two weeks;
- Apply the initial scales
- Test algometry on the muscles affected by pain. This visit will be performed by a blinded investigator
Visit 2 (V2) - Randomization and treatment visit • Apply the experimental or sham treatment according to randomization This visit will be performed by an unblinded investigator
Visit 3 (V3) - Reassessment visit
- Reapply the TotPar and SPID scale and repeat algometry This visit will be performed by a blinded investigator
Visit 4 (V4) - Telephone reassessment visit
- After 24h of V3
- Reapply the TotPar and SPID scale This visit will be performed by a blinded investigator
Visit 5 (V5) - Telephone reassessment visit
- After 24h of V4
- Reapply the TotPar and SPID scale This visit will be performed by a blinded investigator
Visit 6 (V6) - Telephone reassessment visit
- After 24h of V5
- Reapply the TotPar and SPID scale SPID This visit will be conducted by a blinded investigator
Visit 7 (V7) - Telephone reassessment visit
- After 24h from V6
- Reapply the TotPar and SPID scale This visit will be conducted by a blinded investigator
Visit 8 (V8) - Telephone reassessment visit
- After 24h from V7
- Reapply the TotPar and SPID scale This visit will be conducted by a blinded investigator
Visit 9 (V9) - Telephone reassessment visit
- After 24h from V8
- Reapply the TotPar and SPID scale This visit will be conducted by a blinded investigator
Visit 10 (V10) - Closing visit
- After 24h from V9
- Reapply the TotPar and SPID scale
- Final reassessment
- Referral for follow-up This visit will be conducted by a blinded investigator.
Statistical Plan The outcome is of an ordinal qualitative nature and, therefore, the one-tailed non-parametric Mann-Whitney-Wilcoxon test will be used to verify whether laser is superior to sham acupuncture in reducing pain.
The outcome is of an ordinal qualitative nature and, therefore, the Fischer test will be used to verify whether laser is superior to sham acupuncture in reducing pain. The sample size calculation was performed using the G*Power software, considering that the statistical analysis will be performed using the Fisher test:
- Fisher's Exact Test
- One-tailed Hypothesis Test
- Two independent groups
- Options: Exact distribution
- Input: Tail(s) = One
- Proportion p1 = 0.8
- Proportion p2 = 0.5
- Significance Level (α error) = 0.05
- Power (1-β error) = 0.95
- Allocation ratio N2/N1 = 1
- Output: Sample size group Active Laser Group = 59
- Sample size group Placebo Group = 59
- Total sample size = 118
- Real power = 0.9521908
- Real α = 0.0399172 Randomization will be stratified by gender and the sequence will be generated by the SEALED ENVELOPE portal available at https://www.sealedenvelope.com/.
Blinding The study will be double-blind, with the participation of a blinded investigator and an unblinded investigator.
Source of Patients for the study Patients who were referred to the outpatient clinic of the Acupuncture Center of the IOTHCFMUSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser auriculotherapy | Experimental | Device: Laser AuriculotherapyFrench 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. |
| Placebo auriculotherapy | Placebo comparator | Device: Laser AuriculotherapyPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AuriculotherapyAlso: PhotobiomodulationFrench 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 |
Primary outcome
Algometry
Time frame: 1 hour after intervention
Increase in pain tolerance will be assessed by Algometry of the affected muscles
5 secondary outcomes
TotPar Scale
Time frame: 1 week after intervention
SPID Scale
Time frame: 1 week after intervention
Visual analogue scale
Time frame: 1 week after intervention
Rescue medication
Time frame: 1 week after intervention
Adverse Events
Time frame: 1 week after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. Initially the data will be anonymized and will be available for possible auditing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelo N de Paula, PHD Student principal investigator
Faculty of Medicine of the University of São Paulo
Wu T Hsing, PHD study chair
Faculty of Medicine of the University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Laser Auriculotherapy in people with Low Back Pain, run by Marcelo Neubauer de Paula.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo N de Paula, PHD student (+ 55 11 98950 5447, keptah3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algometry (time frame: 1 hour after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.