Low Back Pain Clinical Trial
Official title:
Developing a Method of Rehabilitation for Patients After Myocardial Revascularization Combined With Low Back Pain and Criteria for Evaluating Its Effectiveness
Verified date | January 2022 |
Source | Gomel State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
As a result, will be developed: a list of criteria for functional impairment in patients after myocardial revascularization combined with low back pain; a list of criteria for disabilities in patients after myocardial revascularization combined with low back pain; method of medical rehabilitation of patients after myocardial revascularization combined with low back pain; and criteria for evaluating its effectiveness.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 60 Years |
Eligibility | Inclusion Criteria: Patients After Myocardial Revascularization Combined With Low Back Pain of 40-60 years of age Exclusion Criteria: - Arterial hypertension - Heart attack - Atherosclerosis - Stroke - Coronary heart disease |
Country | Name | City | State |
---|---|---|---|
Belarus | Gomel State Medical University | Gomel | Province |
Lead Sponsor | Collaborator |
---|---|
Gomel State Medical University |
Belarus,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Back pain | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
21 days after intervention of rehabilitation method | |
Primary | Heartache | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
21 days after intervention of rehabilitation method | |
Primary | Angina pectoris | ECG. Reveal the signs of ischemia (deviation of ST segment). | 21 days after intervention of rehabilitation method | |
Primary | Arrhythmia | Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia. | 21 days after intervention of rehabilitation method | |
Primary | Exercise tolerance | Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve. | 21 days after intervention of rehabilitation method | |
Primary | Paresis | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
21 days after intervention of rehabilitation method | |
Primary | Blood pressure level | Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg) | 21 days after intervention of rehabilitation method | |
Primary | Mobility | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
21 days after intervention of rehabilitation method | |
Primary | Self-service | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
21 days after intervention of rehabilitation method | |
Primary | Work capacity | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
21 days after intervention of rehabilitation method | |
Primary | Back pain | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
6 months after intervention of rehabilitation method | |
Primary | Heartache | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
6 months after intervention of rehabilitation method | |
Primary | Angina pectoris | ECG. ECG. Reveal the signs of ischemia (deviation of ST segment). | 6 months after intervention of rehabilitation method | |
Primary | Arrhythmia | Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia. | 6 months after intervention of rehabilitation method | |
Primary | Exercise tolerance | Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve. | 6 months after intervention of rehabilitation method | |
Primary | Paresis | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
6 months after intervention of rehabilitation method | |
Primary | Blood pressure level | Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg) | 6 months after intervention of rehabilitation method | |
Primary | Mobility | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
6 months after intervention of rehabilitation method | |
Primary | Self-service | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
6 months after intervention of rehabilitation method | |
Primary | Work capacity | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
6 months after intervention of rehabilitation method | |
Primary | Back pain | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
1 year after intervention of rehabilitation method | |
Primary | Heartache | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
1 year after intervention of rehabilitation method | |
Primary | Angina pectoris | ECG. Reveal the signs of ischemia (deviation of ST segment). | 1 year after intervention of rehabilitation method | |
Primary | Arrhythmia | Holter monitor. Assessment of painless ischemia, heart rhythm disorders, silent ischemia. | 1 year after intervention of rehabilitation method | |
Primary | Exercise tolerance | Treadmill Exercise Stress Test. Assessment of exercise tolerance, coronary reserve. | 1 year after intervention of rehabilitation method | |
Primary | Paresis | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
1 year after intervention of rehabilitation method | |
Primary | Blood pressure level | Systolic blood pressure and Diastolic blood pressure is measured in units of millimeters of mercury (mmHg) | 1 year after intervention of rehabilitation method | |
Primary | Mobility | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
1 year after intervention of rehabilitation method | |
Primary | Self-service | Self-report according to the questionnaire Short Form Medical Outcomes Study SF-36. (SF-36, 1998), ranges from 0 to 100.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is commonly used as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. |
1 year after intervention of rehabilitation method | |
Primary | Work capacity | Visual examination with a determination of a degree
The Oxford Scale The most commonly accepted method of evaluating muscle strength is the Oxford Scale (AKA Medical Research Council Manual Muscle Testing scale). This method involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly: Flicker of movement Through full range actively with gravity counterbalanced Through full range actively against gravity Through full range actively against some resistance Through full range actively against strong resistance |
1 year after intervention of rehabilitation method | |
Secondary | Stroke | SCORE 2 chart Risk assessment of cardiovascular accidents. A scale for assessing the risk of death due to cardiovascular disease within 10 years. Assessment is based on the age, sex, systolic pressure (mm.Hg), cholesterol level (mmol/l), smoking status.
Scores: < 1%, 1%, 2 %, 3-4 %, 5-9 %, 10-14 %, 15% and over. |
21 days after intervention of rehabilitation method | |
Secondary | Acute myocardial infarction | Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report). | 21 days after intervention of rehabilitation method | |
Secondary | Death due to vascular diseases | The Lown grading system for ventricular arrhythmias of high rank The Lown grading system is used in observational and experimental studies of ischaemic heart disease. This grading system uses three levels of ventricular premature depolarisation frequency and four complex features to assign patients to one of seven grades.
Assessment occurs depending on the number and type of extrasystoles according to Holter monitoring data. Grades: 0, 1, 2, 3A, 3B, 4A, 4B, 5. |
21 days after intervention of rehabilitation method | |
Secondary | Stroke | SCORE 2 chart Risk assessment of cardiovascular accidents. A scale for assessing the risk of death due to cardiovascular disease within 10 years. Assessment is based on the age, sex, systolic pressure (mm.Hg), cholesterol level (mmol/l), smoking status.
Scores: < 1%, 1%, 2 %, 3-4 %, 5-9 %, 10-14 %, 15% and over. |
6 months after intervention of rehabilitation method | |
Secondary | Acute myocardial infarction | Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report). | 6 months after intervention of rehabilitation method | |
Secondary | Death due to vascular diseases | The Lown grading system for ventricular arrhythmias of high rank The Lown grading system is used in observational and experimental studies of ischaemic heart disease. This grading system uses three levels of ventricular premature depolarisation frequency and four complex features to assign patients to one of seven grades.
Assessment occurs depending on the number and type of extrasystoles according to Holter monitoring data. Grades: 0, 1, 2, 3A, 3B, 4A, 4B, 5. |
6 months after intervention of rehabilitation method | |
Secondary | Stroke | SCORE 2 chart Risk assessment of cardiovascular accidents. A scale for assessing the risk of death due to cardiovascular disease within 10 years. Assessment is based on the age, sex, systolic pressure (mm.Hg), cholesterol level (mmol/l), smoking status.
Scores: < 1%, 1%, 2 %, 3-4 %, 5-9 %, 10-14 %, 15% and over. |
1 year after intervention of rehabilitation method | |
Secondary | Acute myocardial infarction | Increasing levels of cardiac specific biomarkers (CK-MB, Myoglobin, Troponin T and I), ECG, Echocardiography, SCORE 2021 chart, pain (self-report). | 1 year after intervention of rehabilitation method | |
Secondary | Death due to vascular diseases | The Lown grading system for ventricular arrhythmias of high rank The Lown grading system is used in observational and experimental studies of ischaemic heart disease. This grading system uses three levels of ventricular premature depolarisation frequency and four complex features to assign patients to one of seven grades.
Assessment occurs depending on the number and type of extrasystoles according to Holter monitoring data. Grades: 0, 1, 2, 3A, 3B, 4A, 4B, 5. |
1 year after intervention of rehabilitation method |
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