Rehabilitation treatment
Other3-month immobilization period, hyperextension braces for specific fractures, therapeutic exercises, and gradual activity restoration.
NCT Number: NCT06059820
The goal of this observational study is to compare the long-term clinical outcomes of two treatment methods (conservative therapy and surgical treatment) in patients with fractures of the thoracic and lumbar spine without neurological deficit
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Notify Me18 year–65 year
All sexes
Observational
Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine, Moscow, Russia
The main objectives of the upcoming study include:
The research focus will be on patients diagnosed with uncomplicated fractures of the thoracic and lumbar spine, classified as type A2 and A3 according to the AOSpine classification.
Two patient groups will be formed:
The main group (prospective) will consist of patients who underwent conservative therapy. The expected number of observations in the main group will be 40 patients.
The control group (historical control) will be comprised of 40 patients who underwent surgery previously at the Sklifosovsky Research Institute for Emergency Medicine.
The first stage of conservative therapy will be administered within 7 days at the departments of the Sklifosovsky Research Institute for Emergency Medicine. Subsequently, the patient will be transferred to a rehabilitation center for the second stage of conservative treatment at Branch No. 3 of the State Autonomous Healthcare Institution "Moscow Scientific and Practical Center for Medical Rehabilitation, Restorative and Sports Medicine". The third stage of medical rehabilitation will be carried out at outpatient healthcare facilities based on the patient's place of residence.
The study will be considered complete when the data from the final examination of at least 50 patients in each group have been analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3-month immobilization period, hyperextension braces for specific fractures, therapeutic exercises, and gradual activity restoration.
Pedicle screw fixation or fusion; anterior plate fusion
Time frame: admission, 3, 6 and 12 months
This questionnaire allows for a precise numeric assessment of the extent to which an individual's daily functioning is affected by back pain and objectively demonstrates the clinical outcome of the provided treatment. The scale will be applied at all stages of the study, starting from the initial examination and concluding with the follow-up examination one year after intervention. The questionnaire consists of 10 sections, each containing 6 statements. Depending on the response, a score from 0 to 5 is assigned. The maximum total score is 50. Subsequently, the scores are converted into percentages, ranging from 0 to 100%. If one of the sections is not applicable or omitted for ethical reasons, the sum of scores from the remaining 9 sections is divided by 45 to calculate the percentage.
Time frame: admission, 3, 6 and 12 months
This questionnaire allows for a comprehensive assessment of the quality of life. The questionnaire consists of 36 questions grouped into 8 scales, evaluating physical functioning, role limitations, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale has a maximum score of 100 points.
Time frame: admission, 3, 6 and 12 months
This scale is similar to the SF-36 but provides a less detailed assessment of the social adaptation of patients and their emotional well-being. Nevertheless, this questionnaire is frequently used in prospective international research studies. Therefore, we consider it practical to use it to preserve the option for comparative analysis of our results with literature data. The questionnaire consists of 5 sections (mobility, self-care, usual activities, pain, anxiety), each with three statements, and a visual analogue scale EQ-VAS. The results can be converted into a single numerical value (index) adjusted for the patient's region of residence. Currently, there is no complete set of values to calculate this index for the Russian Federation, so in the initial stages, simple comparison of specific numerical values for each parameter will be used. When the technical capability becomes available, the index will be calculated at the end of the study.
Time frame: admission
This classification categorizes patients into 5 classes based on the presence of comorbid conditions (Class I - healthy patient, Class V - moribund patient).
Time frame: 1, 3, 6 and 12 months
The Rivermead Mobility Index (RMI) is a tool used to assess the mobility of patients, particularly after injuries or conditions such as stroke. This index is designed to measure a patient's ability to perform various motor tasks and includes an evaluation of aspects such as getting out of bed, moving around a room, descending stairs, and other mobility skills.
The Rivermead Mobility Index consists of several questions and items, each of which is assigned a specific score. All scores are then summed to determine the overall mobility index. This tool can be used for both medical and research purposes to assess patients' physical function and mobility.
Time frame: 1, 3, 6 and 12 months
Lovett's method is a clinical technique to assess erector spinae muscle strength. It involves having the patient perform specific movements or resist against applied force. This evaluates muscle strength and functional status. It's used in medical and physical therapy assessments for the lower back.
Sklifosovsky Institute of Emergency Care
Other Gov
Prospective Cohort Study of the Effectiveness of Conservative Treatment in Patients With AOSpine Type A2 and A3 Fractures of the Thoracic and Lumbar Spine Without Neurological Deficit
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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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