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

NCT07745088 | Completed DMC

• 2 other identifiers: FNS-001-20258600299247
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Pain Intervention

Outcome Measures

Primary Outcomes (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.

  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

  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

Study Arms (2)

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.

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.

Other: Placebo

Interventions

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

Also known as: Routine Management

Sham Procedure

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.

Atlasprofilax

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Nacional Somos: lead
• Cooperative University of Colombia: collaborator

Study Sites (1)

Bogota

Bogotá, Colombia

Location

Related Publications (5)

• 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.

  PMID: 29559834 BACKGROUND

• 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.

  PMID: 7852102 BACKGROUND

• 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.

  PMID: 9004119 BACKGROUND

• 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.

  PMID: 25492697 BACKGROUND

• 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.

  PMID: 29689229 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hector Fabio Restrepo-Guerrero

  FNS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: August 4, 2026
• Study Start: January 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)