Subluxation and Dislocation of C0/C1 Cervical VertebraeAtlaStandardNCT05986656
X-ray Evaluation of the Effectiveness of the Atlas Correction in Patients With Chronic Subluxation of the Atlas
A study testing Atlas-Standard method in people with Subluxation and Dislocation of C0/C1 Cervical Vertebrae, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subluxation and Dislocation of C0/C1 Cervical Vertebrae
- What is being tested?
- Atlas-Standard method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteRussia
- Study dates
- 8 Sep 2023to 14 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Atlas-Standard method
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atlas-Standard methodProcedure or surgery
Hardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra.
| Study group | Role | What they receive |
|---|---|---|
| Atlas correction | Experimental | Basic group. Receives: Procedure: Atlas-Standard method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month.
Secondary outcomes (5)
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")
Measured: 6 month
Painkillers
Number of participants who use painkillers before and after procedure
Measured: 6 month
The functional disability
Evaluated with the Oswestry Disability Index (ODI: 0 = minimal [better outcome] to 100% = maximal disability [worse outcome])
Measured: 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
Measured: 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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Sep 2023
- Primary completion30 May 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subluxation and Dislocation of C0/C1 Cervical VertebraeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Borsuk, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Investigators
- Denis Borsuk, Study chair, South Ural Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986656
- Sponsor's protocol ID
- 13072023
- Acronym
- AtlaStandard
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05986656
- Acronym / sponsor ID
- AtlaStandard / 13072023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, RussiaUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atlas correction | Experimental | Procedure: Atlas-Standard methodBasic group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atlas-Standard methodHardware acupressure of the suboccipital muscles according to the Atlas-Standard method for the reduction of chronic subluxation of the first cervical vertebra. | Procedure or surgery | Atlas correction |
Primary outcome
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
5 secondary outcomes
Pain level
Time frame: 6 month
Painkillers
Time frame: 6 month
The functional disability
Time frame: 6 month
Changes in the angles of deviation of the spinous processes
Time frame: 6 month
Changes in the range of motion of the spine
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Borsuk study chair
South Ural Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atlas-Standard method in people with Subluxation and Dislocation of C0/C1 Cervical Vertebrae, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.