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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Colombia1 site
  • Bogota

    Bogotá

Other trials in Colombia

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.

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 groups in NCT07745088
Study groupRoleWhat they receive
AtlasprofilaxExperimentalParticipants 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 ProcedurePlacebo comparatorParticipants 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.

  1. 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)
  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.

  1. First posted4 Aug 2026
  2. Study start1 Jan 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2025

Resources

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)
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 29559834
  • Hallgren 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 7852102
  • McPartland 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 9004119
  • Basson 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 25492697
  • Charras 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

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.

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