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The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| walking exercise group | Experimental | **walking exercise with bracing exercise
|
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| stabilization exercise group | Experimental | ** stabilization exercise with bracing exercise
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| walking and stabilization exercise group | Experimental | **walking exercise, bracing exercise with stabilization exercise
|
|
| flexibility exercise group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Low Back Pain at Resting Status | numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain). | Baseline Pre-Exercise and 6 weeks |
| Disability for Low Back Pain | Oswestry disability index(ODI) (Unit: Point) The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.[](streamdown:incomplete-link) | Baseline Pre-Exercise and 6 weeks |
| Visual Analog Scale of Low Back Pain During Rest | visual analog scale of low back pain during resting status at 0 week and 6 week Record 'no pain' on the left side of the line as 'unpaid pain' on the right side and indicate the degree of pain in the subject(0 to 100) 0 is equated with 'no pain' and 100 is 'unpaid pain' | 0 week to 6weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Strength(Endurance) | endurances of specific posture (sec) (supine, side-lying and prone) | Baseline Pre-Exercise and 6 weeks |
| Depression Scale | Beck depression inventory consisted of 21 questions about how the subject has been feeling in the last week. Each question had a set of four possible responses, ranging in intensity(0 is weak and 3 is severe). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The total score is 63, higher total scores indicate more severe depressive symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juseok Ryu, MD, PhD | Seoul National University Bundang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Kyungji-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25122093 | Result | Lee HI, Lee ST, Kim M, Ryu JS. Sex differences in predicting chronicity of low-back pain after acute trauma using lumbar muscle area. Am J Phys Med Rehabil. 2015 Feb;94(2):123-30. doi: 10.1097/PHM.0000000000000149. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Walking Exercise Group | **walking exercise •walking exercise: treadmill gait with tolerable gait speed |
| FG001 | Stabilization Exercise Group | ** stabilization exercise •stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. |
| FG002 | Walking and Stabilization Exercise Group | **walking exercise with stabilization exercise
|
| FG003 | Flexibility Exercise Group | **Stretching exercise(control)
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Walking Exercise Group | **walking exercise •walking exercise: treadmill gait with tolerable gait speed |
| BG001 | Stabilization Exercise Group | ** stabilization exercise •stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Low Back Pain at Resting Status | numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain). | Posted | Mean | Standard Deviation | score on a scale | Baseline Pre-Exercise and 6 weeks |
|
12weeks
This study did not exceed the minimal risk, so a data safety monitoring plan would not be needed.
There were no adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Walking Exercise Group | **walking exercise with bracing exercise
exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juseok Ryu | Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine | +82-10-4382-2328 | jseok337@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2017 | Sep 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Sham Comparator |
**Stretching exercise(control)
|
|
|
| 6 weeks |
| BG002 | Walking and Stabilization Exercise Group | **walking exercise with stabilization exercise
|
| BG003 | Flexibility Exercise Group | **Stretching exercise(control)
|
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Walking and Stabilization Exercise Group | **walking exercise with stabilization exercise
exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. -bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and i |
| OG003 | Flexibility Exercise Group | **Stretching exercise(control)
exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.
|
|
|
| Primary | Disability for Low Back Pain | Oswestry disability index(ODI) (Unit: Point) The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.[](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | score on a scale | Baseline Pre-Exercise and 6 weeks |
|
|
|
| Primary | Visual Analog Scale of Low Back Pain During Rest | visual analog scale of low back pain during resting status at 0 week and 6 week Record 'no pain' on the left side of the line as 'unpaid pain' on the right side and indicate the degree of pain in the subject(0 to 100) 0 is equated with 'no pain' and 100 is 'unpaid pain' | Posted | Mean | Standard Deviation | score on a scale | 0 week to 6weeks |
|
|
|
| Secondary | Muscle Strength(Endurance) | endurances of specific posture (sec) (supine, side-lying and prone) | Posted | Mean | Standard Deviation | second | Baseline Pre-Exercise and 6 weeks |
|
|
|
| Secondary | Depression Scale | Beck depression inventory consisted of 21 questions about how the subject has been feeling in the last week. Each question had a set of four possible responses, ranging in intensity(0 is weak and 3 is severe). When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The total score is 63, higher total scores indicate more severe depressive symptoms. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Stabilization Exercise Group | ** stabilization exercise •stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Walking and Stabilization Exercise Group | **walking exercise with stabilization exercise
| 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | Flexibility Exercise Group | **Stretching exercise(control)
| 0 | 13 | 0 | 13 | 0 | 13 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| After 6 weeks |
|
| After 6 weeks |
|
| After 6 weeks |
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