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

NCT05986656 | Completed

• 1 other identifier: 13072023
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subluxation and Dislocation of C0/C1 Cervical Vertebrae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain level

  6 month

• Painkillers

  6 month

• The functional disability

  6 month

• Changes in the angles of deviation of the spinous processes

  6 month

• Changes in the range of motion of the spine

  6 month

Study Arms (1)

Atlas correction

EXPERIMENTAL

Basic group.

Procedure: Atlas-Standard method

Interventions

Atlas-Standard method PROCEDURE

Hardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra.

Atlas correction

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia: lead

Study Sites (1)

Astrakhan Regional Clinical Hospital

Astrakhan, Russia

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Denis Borsuk

  South Ural Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 14, 2023
• Study Start: September 8, 2023
• Primary Completion: May 30, 2024
• Study Completion: July 14, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)