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OpenTrials
Completed

NCT Number: NCT07745088

Impact on Patients With Neuromuscular and Musculoskeletal Conditions Associated With Benign Chronic Pain Using Atlas Profilapxis

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.

Completed

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bogota

Bogotá, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults over the age of 18
  • patient who consult the authorized Atlas care center
  • patients with chronic non-malignant pain.

Exclusion criteria

  • Inability to perform physical therapies.
  • patient with pain neuropatict indiferent

Treatment and study plan

Placebo

Other

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

Other names: Routine Management

Atlasprofilax Therapy

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Fundacion Nacional Somos

Other

Collaborators

  • Cooperative University of Colombia

Registry information

Acronym: Atlasprofilax

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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