FibromyalgiaFibroIANCT06672419
Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)
A study testing AI-Guided Exercise and Pain Neuroscience Education in people with Fibromyalgia and Fibromyalgia Syndrome, run by Instituto Neurociencia Del Dolor at 2 sites in 2 countries.
Trial summary
This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or enhanced usual care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia, Fibromyalgia Syndrome
- What is being tested?
- AI-Guided Exercise and Pain Neuroscience Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Feb 2026to 14 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016).
- Age between 18 and 65 years.
- Access to an internet-connected device (smartphone or computer).
- Ability to participate in a tele-rehabilitation program.
Who cannot join
- Participation in another clinical trial in the last 3 months.
- Pregnancy or breastfeeding.
- Uncontrolled severe medical conditions that could interfere with the intervention (e.g., cardiac or pulmonary diseases).
- Physical or cognitive impairments that prevent following the exercise program.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial
This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or enhanced usual care. The primary outcome is change in pain intensity from baseline to post-intervention (week 13 ± 7 days), with secondary outcomes including physical function and health-related quality of life. Outcome assessors, the principal investigator, and the study statistician will be blinded to group allocation until database lock.
Read the detailed description
This randomized controlled trial aims to evaluate the effectiveness of a 12-week tele-rehabilitation program that integrates artificial intelligence (AI)-guided exercise, computer vision, and pain neuroscience education (PNE) for individuals with fibromyalgia (FM). The study seeks to determine whether this technology-driven approach can reduce pain intensity, improve physical function, and enhance quality of life in a population that frequently experiences limited benefit from conventional treatment strategies.
Intervention Participants in the intervention group will use a tele-rehabilitation platform that applies AI and computer vision to deliver personalized exercise programs. The AI system monitors performance in real time and adapts exercises according to individual capacity, performance, and progress. In parallel, participants will complete one asynchronous online Pain Neuroscience Education (PNE) module per week for 12 weeks, designed to promote pain reconceptualization and support active self-management..
Control group Participants in the control group receive enhanced usual care for fibromyalgia according to clinical guidelines, including continuation of prescribed pharmacological management and general lifestyle, physical activity, and self-management advice. In addition, participants use the same digital platform with a visually identical interface and receive standard, non-specific educational materials on fibromyalgia self-management and general physical activity guidance, without AI-guided exercise feedback or structured Pain Neuroscience Education modules.
Study Design This study employs a parallel-group randomized controlled trial (RCT) design. Participants are randomly assigned in a 1:1 ratio to either the intervention group, which receives AI-guided exercise and Pain Neuroscience Education through a tele-rehabilitation platform, or the control group, which receives enhanced usual care for fibromyalgia, including usual pharmacological management, general physical activity and self-management guidance, and access to non-specific digital educational materials without AI-guided exercise feedback or structured PNE modules. The study is conducted remotely. Randomization is performed using a computer-generated allocation sequence.
Masking: Because of the nature of the non-pharmacological digital exercise intervention, complete blinding of participants and treating physiotherapists was not feasible. Outcome assessors, the principal investigator, and the study statistician remained blinded to group allocation until database lock. Treating physiotherapists were not involved in outcome assessment.
Objectives
The primary objective is to determine whether the AI-guided exercise and PNE program reduces pain intensity and improves physical function compared with standard care. Secondary objectives include evaluating changes in quality of life, psychological well-being, and treatment adherence. Findings will provide evidence on whether technology-enabled rehabilitation can serve as an accessible, effective alternative for fibromyalgia management.
Rationale
Conventional therapies for fibromyalgia, such as pharmacological treatment and standard physical therapy, often provide suboptimal relief. Tele-rehabilitation represents a promising strategy to deliver personalized, supervised exercise at scale, particularly for patients in underserved or remote areas. When combined with pain neuroscience education, this approach addresses both physical and cognitive aspects of pain, with the potential to improve outcomes beyond current standards of care.
This study aligns with broader public health goals to improve access to effective interventions for chronic pain. Its results may inform future clinical guidelines and support the integration of AI-driven tele-rehabilitation into routine practice for fibromyalgia and related chronic pain conditions.
- Conditions
- Fibromyalgia, Fibromyalgia Syndrome
- Being tested
- AI-Guided Exercise and Pain Neuroscience Education, Enhanced Usual Care for Fibromyalgia
- Keywords
- Fibromyalgia, Tele-rehabilitation, Artificial Intelligence, Computer Vision, Pain Neuroscience Education, Randomized Controlled Trial
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Guided Exercise and Pain Neuroscience EducationOther
This intervention consists of a 12-week tele-rehabilitation program using artificial intelligence and computer vision to guide personalized therapeutic exercise sessions three times per week. The platform provides real-time feedback on movement execution and individualized exercise progression. Participants additionally complete one asynchronous online Pain Neuroscience Education module per week for 12 weeks. Supervising physiotherapists review adherence and safety alerts and are not involved in outcome assessment.
Enhanced Usual Care for FibromyalgiaOther
Enhanced usual care includes continuation of prescribed pharmacological management and general recommendations regarding physical activity, lifestyle, and fibromyalgia self-management. Participants also receive access to standard, non-specific digital educational materials and general activity guidance, without AI-guided real-time exercise feedback or structured Pain Neuroscience Education modules.
| Study group | Role | What they receive |
|---|---|---|
| AI-Guided Tele-rehabilitation | Experimental | Participants in this arm receive a 12-week home-based tele-rehabilitation program combining AI- and computer vision-guided therapeutic exercise with Pain Neuroscience Education. Participants complete three personalized exercise sessions per week. The platform analyzes movement performance in real time, provides audiovisual corrective feedback, and adapts exercise difficulty according to individual performance and adherence data. Participants also complete one asynchronous online PNE module per week for 12 weeks. Supervising physiotherapists review adherence and safety alerts but are not involved in outcome assessment; complete blinding of treating physiotherapists is not feasible. Receives: Other: AI-Guided Exercise and Pain Neuroscience Education |
| Enhanced Usual Care for Fibromyalgia | Active comparator | Participants in this arm receive enhanced usual care for fibromyalgia according to clinical guidelines, including continuation of prescribed pharmacological management and general lifestyle, physical activity, and self-management advice. In addition, participants use the same digital platform with a visually identical interface and receive standard, non-specific educational materials on fibromyalgia self-management and general physical activity guidance, without AI-guided exercise feedback or structured Pain Neuroscience Education modules. Receives: Other: Enhanced Usual Care for Fibromyalgia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity is measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The primary endpoint is the change in VAS pain intensity between baseline (Week 0) and the post-intervention assessment at Week 13 (±7 days), immediately following completion of the 12-week intervention. Higher scores indicate greater pain intensity.
Measured: Baseline to Week 13 (±7 days)
Secondary outcomes (5)
Change in the Impact of Fibromyalgia on Daily Life Measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
The impact of fibromyalgia is assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R), with a total score ranging from 0 to 100, where higher scores indicate greater disease impact. Change in the total FIQ-R score is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
Measured: Baseline to Week 13 (±7 days)
Change in Lower Limb Strength and Endurance Measured by the 30-Second Sit-to-Stand Test
Lower limb strength and endurance are assessed using the 30-Second Sit-to-Stand Test, recorded as the number of complete repetitions performed within 30 seconds. Higher values indicate better physical performance. Change is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
Measured: Baseline to Week 13 (±7 days)
Change in Health-Related Quality of Life Measured by the EQ-5D-3L
Health-related quality of life is assessed using the EQ-5D-3L. The utility index ranges from negative values to 1, with higher scores indicating better health-related quality of life. Change in the EQ-5D-3L index is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
Measured: Baseline to Week 13 (±7 days)
Change in Psychological Well-being Measured by the Numeric Rating Scale for Anxiety (NRS-A)
Anxiety is assessed using the Numeric Rating Scale for Anxiety (NRS-A), ranging from 0 (no anxiety) to 10 (worst imaginable anxiety), with higher scores indicating greater anxiety. Change is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
Measured: Baseline to Week 13 (±7 days)
Perceived Barriers to Treatment Adherence Measured by the Treatment Adherence Barriers Questionnaire
Perceived barriers to treatment adherence are assessed using the Treatment Adherence Barriers Questionnaire adapted for tele-rehabilitation. The measure evaluates logistical, motivational, contextual, and other perceived barriers to adherence. Assessments are performed at baseline (Week 0) and post-intervention at Week 13 (±7 days).
Measured: Baseline to Week 13 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start10 Feb 2026
- Primary completion14 Jun 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Model description
- This study employs a parallel-group randomized controlled trial (RCT) design. Participants are randomly assigned in a 1:1 ratio to either the intervention group, which receives AI-guided exercise and Pain Neuroscience Education through a tele-rehabilitation platform, or the control group, which receives enhanced usual care for fibromyalgia, including usual pharmacological management, general physical activity and self-management guidance, and access to non-specific digital educational materials without AI-guided exercise feedback or structured PNE modules. The study is conducted remotely. Randomization is performed using a computer-generated allocation sequence.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Neurociencia Del Dolor
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad San Sebastián, Universidad Santiago de Cali
- Responsible party
- Sponsor
- Investigators
- Marco Morales-Osorio, PhD, Principal investigator, Universidad San Sebastian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672419
- Sponsor's protocol ID
- FibroIA
- Other IDs
- ID: USS_0003_11-07-2
- Acronym
- FibroIA
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the main results. Data will be transferred via secure encrypted platforms and shared in compliance with GDPR and HIPAA regulations. Raw platform data (e.g., motion capture logs, video files) will not be shared due to privacy and technical restrictions."
Publications
Morales-Osorio MA, Ordonez-Vega R, Alomia Penafiel GA, Ordonez-Mora LT. Effectiveness of tele-rehabilitation using AI-guided exercise and pain neuroscience education for fibromyalgia (FIBROIA): Protocol for a randomized controlled trial. PLoS One. 2026 May 22;21(5):e0349017. doi: 10.1371/journal.pone.0349017. eCollection 2026.
PubMed 42172217
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06672419
- Acronym / sponsor ID
- FibroIA / FibroIA
- Conditions
- Fibromyalgia, Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Tele-rehabilitation, Artificial Intelligence, Computer Vision, Pain Neuroscience Education, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto Neurociencia Del DolorUniversity, hospital or other
- Collaborators
- Universidad San Sebastián, Universidad Santiago de Cali
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 4 Nov 2024 (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.
This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or enhanced usual care. The primary outcome is change in pain intensity from baseline to post-intervention (week 13 ± 7 days), with secondary outcomes including physical function and health-related quality of life. Outcome assessors, the principal investigator, and the study statistician will be blinded to group allocation until database lock.
Detailed description
This randomized controlled trial aims to evaluate the effectiveness of a 12-week tele-rehabilitation program that integrates artificial intelligence (AI)-guided exercise, computer vision, and pain neuroscience education (PNE) for individuals with fibromyalgia (FM). The study seeks to determine whether this technology-driven approach can reduce pain intensity, improve physical function, and enhance quality of life in a population that frequently experiences limited benefit from conventional treatment strategies.
Intervention Participants in the intervention group will use a tele-rehabilitation platform that applies AI and computer vision to deliver personalized exercise programs. The AI system monitors performance in real time and adapts exercises according to individual capacity, performance, and progress. In parallel, participants will complete one asynchronous online Pain Neuroscience Education (PNE) module per week for 12 weeks, designed to promote pain reconceptualization and support active self-management..
Control group Participants in the control group receive enhanced usual care for fibromyalgia according to clinical guidelines, including continuation of prescribed pharmacological management and general lifestyle, physical activity, and self-management advice. In addition, participants use the same digital platform with a visually identical interface and receive standard, non-specific educational materials on fibromyalgia self-management and general physical activity guidance, without AI-guided exercise feedback or structured Pain Neuroscience Education modules.
Study Design This study employs a parallel-group randomized controlled trial (RCT) design. Participants are randomly assigned in a 1:1 ratio to either the intervention group, which receives AI-guided exercise and Pain Neuroscience Education through a tele-rehabilitation platform, or the control group, which receives enhanced usual care for fibromyalgia, including usual pharmacological management, general physical activity and self-management guidance, and access to non-specific digital educational materials without AI-guided exercise feedback or structured PNE modules. The study is conducted remotely. Randomization is performed using a computer-generated allocation sequence.
Masking: Because of the nature of the non-pharmacological digital exercise intervention, complete blinding of participants and treating physiotherapists was not feasible. Outcome assessors, the principal investigator, and the study statistician remained blinded to group allocation until database lock. Treating physiotherapists were not involved in outcome assessment.
Objectives
The primary objective is to determine whether the AI-guided exercise and PNE program reduces pain intensity and improves physical function compared with standard care. Secondary objectives include evaluating changes in quality of life, psychological well-being, and treatment adherence. Findings will provide evidence on whether technology-enabled rehabilitation can serve as an accessible, effective alternative for fibromyalgia management.
Rationale
Conventional therapies for fibromyalgia, such as pharmacological treatment and standard physical therapy, often provide suboptimal relief. Tele-rehabilitation represents a promising strategy to deliver personalized, supervised exercise at scale, particularly for patients in underserved or remote areas. When combined with pain neuroscience education, this approach addresses both physical and cognitive aspects of pain, with the potential to improve outcomes beyond current standards of care.
This study aligns with broader public health goals to improve access to effective interventions for chronic pain. Its results may inform future clinical guidelines and support the integration of AI-driven tele-rehabilitation into routine practice for fibromyalgia and related chronic pain conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a parallel-group randomized controlled trial (RCT) design. Participants are randomly assigned in a 1:1 ratio to either the intervention group, which receives AI-guided exercise and Pain Neuroscience Education through a tele-rehabilitation platform, or the control group, which receives enhanced usual care for fibromyalgia, including usual pharmacological management, general physical activity and self-management guidance, and access to non-specific digital educational materials without AI-guided exercise feedback or structured PNE modules. The study is conducted remotely. Randomization is performed using a computer-generated allocation sequence.
| Arm | Type | Receives |
|---|---|---|
| AI-Guided Tele-rehabilitation | Experimental | Other: AI-Guided Exercise and Pain Neuroscience EducationParticipants in this arm receive a 12-week home-based tele-rehabilitation program combining AI- and computer vision-guided therapeutic exercise with Pain Neuroscience Education. Participants complete three personalized exercise sessions per week. The platform analyzes movement performance in real time, provides audiovisual corrective feedback, and adapts exercise difficulty according to individual performance and adherence data. Participants also complete one asynchronous online PNE module per week for 12 weeks. Supervising physiotherapists review adherence and safety alerts but are not involved in outcome assessment; complete blinding of treating physiotherapists is not feasible. |
| Enhanced Usual Care for Fibromyalgia | Active comparator | Other: Enhanced Usual Care for FibromyalgiaParticipants in this arm receive enhanced usual care for fibromyalgia according to clinical guidelines, including continuation of prescribed pharmacological management and general lifestyle, physical activity, and self-management advice. In addition, participants use the same digital platform with a visually identical interface and receive standard, non-specific educational materials on fibromyalgia self-management and general physical activity guidance, without AI-guided exercise feedback or structured Pain Neuroscience Education modules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016).
- Age between 18 and 65 years.
- Access to an internet-connected device (smartphone or computer).
- Ability to participate in a tele-rehabilitation program.
Key exclusion criteria (4 listed)
- Participation in another clinical trial in the last 3 months.
- Pregnancy or breastfeeding.
- Uncontrolled severe medical conditions that could interfere with the intervention (e.g., cardiac or pulmonary diseases).
- Physical or cognitive impairments that prevent following the exercise program.
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 |
|---|---|---|
| AI-Guided Exercise and Pain Neuroscience EducationThis intervention consists of a 12-week tele-rehabilitation program using artificial intelligence and computer vision to guide personalized therapeutic exercise sessions three times per week. The platform provides real-time feedback on movement execution and individualized exercise progression. Participants additionally complete one asynchronous online Pain Neuroscience Education module per week for 12 weeks. Supervising physiotherapists review adherence and safety alerts and are not involved in outcome assessment. | Other | AI-Guided Tele-rehabilitation |
| Enhanced Usual Care for FibromyalgiaEnhanced usual care includes continuation of prescribed pharmacological management and general recommendations regarding physical activity, lifestyle, and fibromyalgia self-management. Participants also receive access to standard, non-specific digital educational materials and general activity guidance, without AI-guided real-time exercise feedback or structured Pain Neuroscience Education modules. | Other | Enhanced Usual Care for Fibromyalgia |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline to Week 13 (±7 days)
Pain intensity is measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The primary endpoint is the change in VAS pain intensity between baseline (Week 0) and the post-intervention assessment at Week 13 (±7 days), immediately following completion of the 12-week intervention. Higher scores indicate greater pain intensity.
5 secondary outcomes
Change in the Impact of Fibromyalgia on Daily Life Measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Time frame: Baseline to Week 13 (±7 days)
Change in Lower Limb Strength and Endurance Measured by the 30-Second Sit-to-Stand Test
Time frame: Baseline to Week 13 (±7 days)
Change in Health-Related Quality of Life Measured by the EQ-5D-3L
Time frame: Baseline to Week 13 (±7 days)
Change in Psychological Well-being Measured by the Numeric Rating Scale for Anxiety (NRS-A)
Time frame: Baseline to Week 13 (±7 days)
Perceived Barriers to Treatment Adherence Measured by the Treatment Adherence Barriers Questionnaire
Time frame: Baseline to Week 13 (±7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 42172217Morales-Osorio MA, Ordonez-Vega R, Alomia Penafiel GA, Ordonez-Mora LT. Effectiveness of tele-rehabilitation using AI-guided exercise and pain neuroscience education for fibromyalgia (FIBROIA): Protocol for a randomized controlled trial. PLoS One. 2026 May 22;21(5):e0349017. doi: 10.1371/journal.pone.0349017. eCollection 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request after publication of the main results. Data will be transferred via secure encrypted platforms and shared in compliance with GDPR and HIPAA regulations. Raw platform data (e.g., motion capture logs, video files) will not be shared due to privacy and technical restrictions."
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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. This study is not recruiting at the moment.
Marco Morales-Osorio, PhD principal investigator
Universidad San Sebastian
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Exercise and Pain Neuroscience Education in people with Fibromyalgia and Fibromyalgia Syndrome, run by Instituto Neurociencia Del Dolor at 2 sites in 2 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline to Week 13 (±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06672419, which also lists 1 linked publication.
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 19 Aug 2026.