Back to resultsX-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas (AtlaStandard)
Primary Purpose
Subluxation and Dislocation of C0/C1 Cervical Vertebrae
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Atlas-Standard method
Sponsored by
About this trial
This is an interventional treatment trial for Subluxation and Dislocation of C0/C1 Cervical Vertebrae
Eligibility Criteria
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)
Sites / Locations
- Astrakhan Regional Clinical HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atlas correction
Arm Description
Basic group.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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")
Painkillers
Number of participants who use painkillers before and after procedure
The functional disability
Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])
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
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
Full Information
NCT ID
NCT05986656
First Posted
July 16, 2023
Last Updated
September 9, 2023
Sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05986656
Brief Title
X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas
Acronym
AtlaStandard
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subluxation and Dislocation of C0/C1 Cervical Vertebrae
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atlas correction
Arm Type
Experimental
Arm Description
Basic group.
Intervention Type
Procedure
Intervention Name(s)
Atlas-Standard method
Intervention Description
Hardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra.
Primary Outcome Measure Information:
Title
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
Description
Elimination of asymmetry between the right and left atlantodental intervals
Time Frame
1 month.
Secondary Outcome Measure Information:
Title
Pain level
Description
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")
Time Frame
1 month
Title
Painkillers
Description
Number of participants who use painkillers before and after procedure
Time Frame
1 month
Title
The functional disability
Description
Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])
Time Frame
1 month
Title
Changes in the angles of deviation of the spinous processes
Description
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
Time Frame
1 month
Title
Changes in the range of motion of the spine
Description
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
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Borsuk
Phone
+79630777333
Email
borsuk-angio@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Borsuk
Organizational Affiliation
South Ural Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Astrakhan Regional Clinical Hospital
City
Astrakhan
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandr Yanpolskii
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas
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