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Completed

NCT Number: NCT05986656

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

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.

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Key information

Conditions

Subluxation and Dislocation of C0/C1 Cervical Vertebrae Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Astrakhan Regional Clinical Hospital

Astrakhan, Russia

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

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.

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

    Time frame: 1 month.

    Elimination of asymmetry between the right and left atlantodental intervals

Secondary outcomes

  1. Pain level

    Time frame: 6 month

    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")

  2. Painkillers

    Time frame: 6 month

    Number of participants who use painkillers before and after procedure

  3. The functional disability

    Time frame: 6 month

    Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])

  4. Changes in the angles of deviation of the spinous processes

    Time frame: 6 month

    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

  5. Changes in the range of motion of the spine

    Time frame: 6 month

    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

Sponsors and collaborators

Lead sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Other

Registry information

Official study title

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

Acronym: AtlaStandard

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jul 23, 2024

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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