The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis

Study Overview
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Brief Summary
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The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.

Detailed Description
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Design: Prospective study Setting: hospital rehabilitation department Intervention: Participants are randomly assigned 4 different exercise group: flexibility exercise, bracing exercise + stabilization exercise group, bracing exercise+ walking exercise group and bracing+ walking + stabilization exercise group Main outcome measures: Numeric rating scale(NRS), Oswestry disability index Peak torque of lumbar extensor by surface electromyography Time duration of capability of maintenance the posture

Official Title
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The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>20 Who suffered low back pain more than 3 months. Exclusion Criteria: Pregnancy Under 20-year-old Who have significant neurologic deficit Who experienced spine operation Who cannot walking

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: walking exercise group<br>**walking exercise with bracing exercise walking exercise: treadmill gait with tolerable gait speed bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this. | Behavioral: exercise<br>* 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 in toward your spine without moving your pelvis. Continue to breathe normally as you do this. walking exercise: treadmill gait with tolerable gait speed flexibility exercise: stretching exercise(control)<br>|
| Experimental: stabilization exercise group<br>** stabilization exercise with bracing 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 in toward your spine without moving your pelvis. Continue to breathe normally as you do this. | Behavioral: exercise<br>* 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 in toward your spine without moving your pelvis. Continue to breathe normally as you do this. walking exercise: treadmill gait with tolerable gait speed flexibility exercise: stretching exercise(control)<br>|
| Experimental: walking and stabilization exercise group<br>**walking exercise, bracing exercise with 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. bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this. walking exercise:treadmill gait with tolerable gait speed | Behavioral: exercise<br>* 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 in toward your spine without moving your pelvis. Continue to breathe normally as you do this. walking exercise: treadmill gait with tolerable gait speed flexibility exercise: stretching exercise(control)<br>|
| Sham Comparator: flexibility exercise group<br>**Stretching exercise(control) Only educate the flexibility exercise(stretching exercise) Don't educate the walking exercise method and stabilization exercise method | Behavioral: exercise<br>* 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 in toward your spine without moving your pelvis. Continue to breathe normally as you do this. walking exercise: treadmill gait with tolerable gait speed flexibility exercise: stretching exercise(control)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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.[ | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, exercise, electromyography