X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas (AtlaStandard)

X-ray Assessment of the Effectiveness of Hardware Medical Acupressure of the Suboccipital Muscles According to the "Atlas-Standard" Method in Patients With Chronic Subluxation of the First Cervical Vertebra

The aim of the study is to evaluate the effect of the procedure of medical acupressure of the suboccipital muscles according to the Atlas-Standard method on the normalization of the position of the first cervical vertebra and the angles of the spinal column in patients with diagnosed chronic subluxation with objectification of the results by radiography and inclinometry.

Study Overview

• Status: Completed
• Conditions: Subluxation and Dislocation of C0/C1 Cervical Vertebrae
• Intervention / Treatment: Procedure: Atlas-Standard method

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Astrakhan, Russian Federation
    • Astrakhan Regional Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with chronic subluxation of the first cervical vertebra with complaints of pain in the occiput/cervical/thoracic/lumbar spine/limitation of head rotation in one or both directions.
• Scoliotic deformity of the spine 1-2 degrees.

Exclusion Criteria:

• Pregnancy
• Fractures of the first / second cervical vertebra in history
• Fractures of the spine in any of the departments in the anmenesis
• Assimilation of the atlas with the occipital bone or the second cervical vertebra
• Operations on the spine using metal structures
• Scoliosis 3-4 degree
• Botulinum toxin injections in the suboccipital region within the last year
• Taking muscle relaxants
• Corrective surgery on muscles and bones
• Braces
• Active period of dental implants installation
• Postoperative period (any operation, including on the eyes) less than 6 months
• Acute infectious diseases - less than 2 weeks from the start of recovery
• Skin diseases with inflammatory manifestations in the neck
• Oncological diseases
• Recovery period after injury (cervical and brain injury) or stroke less than a year
• Established mental illness
• Extreme malnutrition (cachexia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atlas correction; Basic group.	Procedure: Atlas-Standard method; Hardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance between righr and left inner surface of the lateral mass of the atlas and the outer surface of the odontoid process of the axis on x-ray	Elimination of asymmetry between the right and left atlantodental intervals	1 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Change in the pain level in the spine according to VAS (Visual Analog Scale from 0 to 10 where 0 is "no pain", 10 is "worst pain imaginable")	6 month
Painkillers	Number of participants who use painkillers before and after procedure	6 month
The functional disability	Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])	6 month
Changes in the angles of deviation of the spinous processes	Measurement of the angles of deviation of the spinous processes in degrees of the frontal and sagittal cavities from C7 to S3 in the position of full flexion, extension of the spine and in the vertical position measured by Spinal Mouse device	6 month
Changes in the range of motion of the spine	Changes in the range of motion of the spine in degrees in the frontal and sagittal planes in the range from C7 to S3 in the position of full flexion and extension of the spine measured by Spinal Mouse device	6 month

Collaborators and Investigators

• Sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
• Investigators: Study Chair: Denis Borsuk, South Ural Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): July 14, 2024

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: 13072023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No