PainAtlasprofilaxNCT07745088
Impact on Patients With Neuromuscular and Musculoskeletal Conditions Associated With Benign Chronic Pain Using Atlas Profilapxis
A study testing Atlasprofilax Therapy in people with Pain and Pain Intervention, run by Fundacion Nacional Somos at 1 site in Colombia.
Trial summary
AtlasPROfilax®is a method performed in 2 authorized centers in Colombia focused on patients with chronic non-malignant pain. The study seeks to see the effectiveness of the method in different pathologies through a randomized double-blind study. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Pain Intervention
- What is being tested?
- Atlasprofilax Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2022to 1 Jun 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over the age of 18
- patient who consult the authorized Atlas care center
- patients with chronic non-malignant pain.
Who cannot join
- Inability to perform physical therapies.
- patient with pain neuropatict indiferent
Trial locations and contacts
1 site in 1 country.
About this study
AtlasPROfilax®is a method performed in 2 authorized centers in Colombia focused on patients with chronic non-malignant pain. The study seeks to see the effectiveness of the method in different pathologies through a randomized double-blind study.
Read the detailed description
The SUPRANAV project, focused on the development, clinical validation and technological evolution of the SUPRAtube medical device, responds to a critical need in the management of mechanically ventilated patients: the optimization of the cleanliness, functionality and safety of the orotracheal tube through an original technological solution, designed in Colombia. This device was evaluated in the framework of a randomized clinical trial, duly registered and published in an indexed scientific journal after peer review, demonstrating its innovative nature and clinical added value. During its initial phases, the project received public funding from MINCIENCIAS, which allowed it to complete its validation in a real clinical environment and reach advanced levels of technological maturity. However, the transition from invention to widespread use in national clinical practice requires a number of highly specialized and expensive activities that were not covered by the original funding.
Progress and Activities Executed in 2024 (With Own Resources) During 2024, the SUPRAtube development team, led from Santander, has assumed an exemplary institutional commitment by continuing with the project despite the absence of direct public funding, executing essential tasks for its effective implementation in the health system: Iterative redesign of the device based on post-trial clinical feedback. 3D printing of new prototypes for functional and usability testing. Optimization of industrial molds for future manufacturing at scale. Technical and regulatory documentation for the sanitary registration with INVIMA. Technological packaging and standardization of components. Adjustments of production plant and technical infrastructure. Testing of quality control, safety and consistency of the final product. These actions, financed with own resources, have required significant investments of time, talent and capital, evidencing a strong ethical, scientific and social commitment on the part of the executing entities. Without them, the real impact of innovation in the national clinical environment would not be possible.
Sectoral and Regional Impact The development and consolidation of the SUPRAtube have been carried out in the department of Santander, which positions the region as a national benchmark in biomedical innovation and technological production in health. The project successfully articulates: Highly complex clinical institutions, research and technological development centers, and specialized industrial companies, creating a regional innovation ecosystem aligned with the public policies of: Reindustrialization of the PND 2022-2026, Health Sovereignty, and The Health Mission of the PIIOM (Mission-Oriented Research and Innovation Policy). A tangible impact is expected on: The quality of care for critical patients, the generation of qualified employment, the transfer of knowledge, and the strengthening of the local business fabric, with national projection. Justification for the Application for Tax Benefits The SUPRANAV / SUPRAtube project fully complies with the technical and strategic requirements established by MINCIENCIAS to access tax benefits in R+D+i activities: It is led by accredited entities, with a proven track record. It involves qualified scientific and technical personnel, with registered remuneration. It aligns with national priorities in health, technology, and productive sovereignty. It was co-financed by MINCIENCIAS during its initial stages (Liquidation Act - August 2024). It presents verifiable results with commercial potential and healthcare impact. It has involved its own institutional investments in key activities not covered by initial public funding. Therefore, this application is not only eligible, but also strategic and necessary, as it brings innovation closer to the end patient and closes the critical gap between invention and real access to the medical device in safe, regulated and scalable conditions. Pending Phases and Projected Improvements To consolidate the impact and ensure sustainability, additional phases have been identified that require support and eventually new investments: Good Manufacturing Practices (GMP) certification. Complementary post-marketing trials. Strategy for adoption and transfer in hospital network. Industrial scaling and strategic licensing. Strategies for technological surveillance and updating of the device. Internationalization and additional protection of intellectual property. These stages will allow the SUPRAtube device not only to benefit the Colombian health system, but also to be projected as an exportable success story of biomedical innovation from regions of Colombia.
- Conditions
- Pain, Pain Intervention
- Being tested
- Placebo, Atlasprofilax Therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called Routine Management
The Sham Atlasprofilax Procedure is a non-therapeutic simulated procedure used as a placebo control. Participants undergo the same preparation, positioning, duration, and clinical setting as the experimental Atlasprofilax Therapy. The same device is applied to the suboccipital region; however, the device is deactivated or set to deliver no effective vibro-pressure, therapeutic frequency, or mechanical stimulation. This procedure is designed to have no neuromuscular or therapeutic effect and is used solely to maintain participant and assessor blindin
Atlasprofilax TherapyProcedure or surgery
Atlasprofilax Therapy is a non-invasive neuromuscular procedure consisting of a single-session application of controlled vibro-pressure to specific points of the suboccipital region. The intervention is performed using a certified mechanical device that delivers digitally controlled percussive vibro-pressure at a predefined frequency and angle, without any manual manipulation of cervical vertebrae. The procedure aims to modulate neuromuscular and fascial tone in the cranio-cervical junction.
| Study group | Role | What they receive |
|---|---|---|
| Atlasprofilax | Experimental | Participants receive the Atlasprofilax therapy, performed using a certified mechanical device that delivers digitally controlled vibropressure stimulation to the suboccipital region, administered by trained personnel. Receives: Procedure: Atlasprofilax Therapy |
| Sham Procedure | Placebo comparator | Participants receive a sham procedure that mimics the Atlasprofilax intervention without delivering active vibropressure stimulation or therapeutic effect. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
Description: The patient is asked to rate their pain on a scale of 1 to 10.
Scoring:
0: No pain. 1-3: Mild or slight pain. 4-6: Moderate pain. 7-10: Severe pain, the worst pain imaginable.
Measurement will be taken on day 1, at 1 month, at 3 months, at 6 months, and at 12 months after the start of the intervention.
Measured: Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention.
Secondary outcomes (1)
fatigue severity scale
This is a 9-item questionnaire that assesses the severity of fatigue and how it interferes with daily activities, using a scale from 1 to 7. It is useful for monitoring fatigue and evaluating the effectiveness of treatments.
Measurement will be taken on day 1, at 1 month, at 3 months, at 6 months, and at 12 months after the start of the intervention.
Measured: Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Nacional Somos
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia
- Responsible party
- Sponsor
- Investigators
- Hector Fabio Restrepo-Guerrero, Study chair, FNS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745088
- Sponsor's protocol ID
- FNS-001-2025
- Other IDs
- 8600299247
- Acronym
- Atlasprofilax
- Status last verified
- Jan 2026
- First submitted
- 6 May 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018.
PubMed 29559834Hallgren RC, Greenman PE, Rechtien JJ. Atrophy of suboccipital muscles in patients with chronic pain: a pilot study. J Am Osteopath Assoc. 1994 Dec;94(12):1032-8.
PubMed 7852102McPartland JM, Brodeur RR, Hallgren RC. Chronic neck pain, standing balance, and suboccipital muscle atrophy--a pilot study. J Manipulative Physiol Ther. 1997 Jan;20(1):24-9.
PubMed 9004119Basson CA, Stewart A, Mudzi W. The effect of neural mobilisation on cervico-brachial pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:419. doi: 10.1186/1471-2474-15-419.
PubMed 25492697Charras G, Yap AS. Tensile Forces and Mechanotransduction at Cell-Cell Junctions. Curr Biol. 2018 Apr 23;28(8):R445-R457. doi: 10.1016/j.cub.2018.02.003.
PubMed 29689229
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Patients With Neuromuscular and Musculoskeletal Conditions Associated With Benign Chronic Pain Using Atlas Profilapxis
- ClinicalTrials.gov ID
- NCT07745088
- Acronym / sponsor ID
- Atlasprofilax / FNS-001-2025
- Conditions
- Pain, Pain Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundacion Nacional SomosUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Aug 2026 (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.
AtlasPROfilax®is a method performed in 2 authorized centers in Colombia focused on patients with chronic non-malignant pain. The study seeks to see the effectiveness of the method in different pathologies through a randomized double-blind study.
Detailed description
The SUPRANAV project, focused on the development, clinical validation and technological evolution of the SUPRAtube medical device, responds to a critical need in the management of mechanically ventilated patients: the optimization of the cleanliness, functionality and safety of the orotracheal tube through an original technological solution, designed in Colombia. This device was evaluated in the framework of a randomized clinical trial, duly registered and published in an indexed scientific journal after peer review, demonstrating its innovative nature and clinical added value. During its initial phases, the project received public funding from MINCIENCIAS, which allowed it to complete its validation in a real clinical environment and reach advanced levels of technological maturity. However, the transition from invention to widespread use in national clinical practice requires a number of highly specialized and expensive activities that were not covered by the original funding.
Progress and Activities Executed in 2024 (With Own Resources) During 2024, the SUPRAtube development team, led from Santander, has assumed an exemplary institutional commitment by continuing with the project despite the absence of direct public funding, executing essential tasks for its effective implementation in the health system: Iterative redesign of the device based on post-trial clinical feedback. 3D printing of new prototypes for functional and usability testing. Optimization of industrial molds for future manufacturing at scale. Technical and regulatory documentation for the sanitary registration with INVIMA. Technological packaging and standardization of components. Adjustments of production plant and technical infrastructure. Testing of quality control, safety and consistency of the final product. These actions, financed with own resources, have required significant investments of time, talent and capital, evidencing a strong ethical, scientific and social commitment on the part of the executing entities. Without them, the real impact of innovation in the national clinical environment would not be possible.
Sectoral and Regional Impact The development and consolidation of the SUPRAtube have been carried out in the department of Santander, which positions the region as a national benchmark in biomedical innovation and technological production in health. The project successfully articulates: Highly complex clinical institutions, research and technological development centers, and specialized industrial companies, creating a regional innovation ecosystem aligned with the public policies of: Reindustrialization of the PND 2022-2026, Health Sovereignty, and The Health Mission of the PIIOM (Mission-Oriented Research and Innovation Policy). A tangible impact is expected on: The quality of care for critical patients, the generation of qualified employment, the transfer of knowledge, and the strengthening of the local business fabric, with national projection. Justification for the Application for Tax Benefits The SUPRANAV / SUPRAtube project fully complies with the technical and strategic requirements established by MINCIENCIAS to access tax benefits in R+D+i activities: It is led by accredited entities, with a proven track record. It involves qualified scientific and technical personnel, with registered remuneration. It aligns with national priorities in health, technology, and productive sovereignty. It was co-financed by MINCIENCIAS during its initial stages (Liquidation Act - August 2024). It presents verifiable results with commercial potential and healthcare impact. It has involved its own institutional investments in key activities not covered by initial public funding. Therefore, this application is not only eligible, but also strategic and necessary, as it brings innovation closer to the end patient and closes the critical gap between invention and real access to the medical device in safe, regulated and scalable conditions. Pending Phases and Projected Improvements To consolidate the impact and ensure sustainability, additional phases have been identified that require support and eventually new investments: Good Manufacturing Practices (GMP) certification. Complementary post-marketing trials. Strategy for adoption and transfer in hospital network. Industrial scaling and strategic licensing. Strategies for technological surveillance and updating of the device. Internationalization and additional protection of intellectual property. These stages will allow the SUPRAtube device not only to benefit the Colombian health system, but also to be projected as an exportable success story of biomedical innovation from regions of Colombia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atlasprofilax | Experimental | Procedure: Atlasprofilax TherapyParticipants receive the Atlasprofilax therapy, performed using a certified mechanical device that delivers digitally controlled vibropressure stimulation to the suboccipital region, administered by trained personnel. |
| Sham Procedure | Placebo comparator | Other: PlaceboParticipants receive a sham procedure that mimics the Atlasprofilax intervention without delivering active vibropressure stimulation or therapeutic effect. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over the age of 18
- patient who consult the authorized Atlas care center
- patients with chronic non-malignant pain.
Key exclusion criteria (2 listed)
- Inability to perform physical therapies.
- patient with pain neuropatict indiferent
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 |
|---|---|---|
| PlaceboAlso: Routine ManagementThe Sham Atlasprofilax Procedure is a non-therapeutic simulated procedure used as a placebo control. Participants undergo the same preparation, positioning, duration, and clinical setting as the experimental Atlasprofilax Therapy. The same device is applied to the suboccipital region; however, the device is deactivated or set to deliver no effective vibro-pressure, therapeutic frequency, or mechanical stimulation. This procedure is designed to have no neuromuscular or therapeutic effect and is used solely to maintain participant and assessor blindin | Other | Sham Procedure |
| Atlasprofilax TherapyAtlasprofilax Therapy is a non-invasive neuromuscular procedure consisting of a single-session application of controlled vibro-pressure to specific points of the suboccipital region. The intervention is performed using a certified mechanical device that delivers digitally controlled percussive vibro-pressure at a predefined frequency and angle, without any manual manipulation of cervical vertebrae. The procedure aims to modulate neuromuscular and fascial tone in the cranio-cervical junction. | Procedure or surgery | Atlasprofilax |
Primary outcome
pain reduction
Time frame: Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention.
Description: The patient is asked to rate their pain on a scale of 1 to 10. Scoring: 0: No pain. 1-3: Mild or slight pain. 4-6: Moderate pain. 7-10: Severe pain, the worst pain imaginable. Measurement will be taken on day 1, at 1 month, at 3 months, at 6 months, and at 12 months after the start of the intervention.
1 secondary outcome
fatigue severity scale
Time frame: Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention
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 4 Aug 2026.
- Background: PubMed 29559834Calvo-Lobo C, Unda-Solano F, Lopez-Lopez D, Sanz-Corbalan I, Romero-Morales C, Palomo-Lopez P, Seco-Calvo J, Rodriguez-Sanz D. Is pharmacologic treatment better than neural mobilization for cervicobrachial pain? A randomized clinical trial. Int J Med Sci. 2018 Mar 8;15(5):456-465. doi: 10.7150/ijms.23525. eCollection 2018.
- Background: PubMed 7852102Hallgren RC, Greenman PE, Rechtien JJ. Atrophy of suboccipital muscles in patients with chronic pain: a pilot study. J Am Osteopath Assoc. 1994 Dec;94(12):1032-8.
- Background: PubMed 9004119McPartland JM, Brodeur RR, Hallgren RC. Chronic neck pain, standing balance, and suboccipital muscle atrophy--a pilot study. J Manipulative Physiol Ther. 1997 Jan;20(1):24-9.
- Background: PubMed 25492697Basson CA, Stewart A, Mudzi W. The effect of neural mobilisation on cervico-brachial pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2014 Dec 10;15:419. doi: 10.1186/1471-2474-15-419.
- Background: PubMed 29689229Charras G, Yap AS. Tensile Forces and Mechanotransduction at Cell-Cell Junctions. Curr Biol. 2018 Apr 23;28(8):R445-R457. doi: 10.1016/j.cub.2018.02.003.
- Individual participant dataSharing planned: No
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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.
Hector Fabio Restrepo-Guerrero study chair
FNS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atlasprofilax Therapy in people with Pain and Pain Intervention, run by Fundacion Nacional Somos at 1 site in Colombia.
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 2 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 4 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 1 site in 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. 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?
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?
pain reduction (time frame: Baseline day 1, post treatment at 1 month post treatment , at 3 months post treatment , at 6 months post treatment, and at 12 months after the start of the intervention.). 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 NCT07745088, which also lists 5 linked publications.
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 4 Aug 2026.