Low Back Pain
Conditions
Keywords
low back pain, exercise, electromyography
Brief summary
The purpose of this study is to determine the effective exercise protocol in chronic low back pain patients.
Detailed description
* 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
Interventions
BEHAVIORALexercise
* 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)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain at Resting Status | Baseline Pre-Exercise and 6 weeks | numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain). |
| Disability for Low Back Pain | Baseline Pre-Exercise and 6 weeks | 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.\[ |
| Visual Analog Scale of Low Back Pain During Rest | 0 week to 6weeks | 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' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength(Endurance) | Baseline Pre-Exercise and 6 weeks | endurances of specific posture (sec) (supine, side-lying and prone) |
| Depression Scale | 6 weeks | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Walking Exercise Group \*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed | 13 |
| 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. | 10 |
| Walking and Stabilization Exercise Group \*\*walking 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.
* walking exercise:treadmill gait with tolerable gait speed | 12 |
| Flexibility Exercise Group \*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method | 13 |
| Total | 48 |
Baseline characteristics
| Characteristic | Total | Stabilization Exercise Group | Walking and Stabilization Exercise Group | Flexibility Exercise Group | Walking Exercise Group |
|---|---|---|---|---|---|
| Age, Continuous | 54.81 years STANDARD_DEVIATION 14.66 | 57.40 years STANDARD_DEVIATION 15.88 | 54.75 years STANDARD_DEVIATION 14.98 | 53.54 years STANDARD_DEVIATION 15.69 | 54.15 years STANDARD_DEVIATION 13.89 |
| Race/Ethnicity, Customized Asian | 48 Participants | 10 Participants | 12 Participants | 13 Participants | 13 Participants |
| Region of Enrollment South Korea | 48 Participants | 10 Participants | 12 Participants | 13 Participants | 13 Participants |
| Sex: Female, Male Female | 15 Participants | 4 Participants | 4 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 33 Participants | 6 Participants | 8 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 10 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 | 0 / 12 | 0 / 13 |
Outcome results
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.\[
Time frame: Baseline Pre-Exercise and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Exercise Group | Disability for Low Back Pain | Pre-exercise | 28.1 score on a scale | Standard Deviation 12.8 |
| Walking Exercise Group | Disability for Low Back Pain | After 6 weeks | 22.5 score on a scale | Standard Deviation 7.4 |
| Stabilization Exercise Group | Disability for Low Back Pain | After 6 weeks | 25.3 score on a scale | Standard Deviation 9.9 |
| Stabilization Exercise Group | Disability for Low Back Pain | Pre-exercise | 31.4 score on a scale | Standard Deviation 13.2 |
| Walking and Stabilization Exercise Group | Disability for Low Back Pain | Pre-exercise | 30.4 score on a scale | Standard Deviation 12.9 |
| Walking and Stabilization Exercise Group | Disability for Low Back Pain | After 6 weeks | 24.9 score on a scale | Standard Deviation 12.3 |
| Flexibility Exercise Group | Disability for Low Back Pain | Pre-exercise | 38.0 score on a scale | Standard Deviation 21.1 |
| Flexibility Exercise Group | Disability for Low Back Pain | After 6 weeks | 31.9 score on a scale | Standard Deviation 18.6 |
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).
Time frame: Baseline Pre-Exercise and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Exercise Group | Low Back Pain at Resting Status | Pre-exercise | 30.58 score on a scale | Standard Deviation 20.92 |
| Walking Exercise Group | Low Back Pain at Resting Status | After 6 weeks | 25.00 score on a scale | Standard Deviation 20.1 |
| Stabilization Exercise Group | Low Back Pain at Resting Status | After 6 weeks | 24.25 score on a scale | Standard Deviation 20.21 |
| Stabilization Exercise Group | Low Back Pain at Resting Status | Pre-exercise | 37.50 score on a scale | Standard Deviation 21.76 |
| Walking and Stabilization Exercise Group | Low Back Pain at Resting Status | Pre-exercise | 30.00 score on a scale | Standard Deviation 30.38 |
| Walking and Stabilization Exercise Group | Low Back Pain at Resting Status | After 6 weeks | 18.33 score on a scale | Standard Deviation 20.93 |
| Flexibility Exercise Group | Low Back Pain at Resting Status | Pre-exercise | 41.92 score on a scale | Standard Deviation 23.32 |
| Flexibility Exercise Group | Low Back Pain at Resting Status | After 6 weeks | 27.89 score on a scale | Standard Deviation 18.54 |
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'
Time frame: 0 week to 6weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Exercise Group | Visual Analog Scale of Low Back Pain During Rest | 20.00 score on a scale | Standard Deviation 17.58 |
| Stabilization Exercise Group | Visual Analog Scale of Low Back Pain During Rest | 22.50 score on a scale | Standard Deviation 23.72 |
| Walking and Stabilization Exercise Group | Visual Analog Scale of Low Back Pain During Rest | 20.83 score on a scale | Standard Deviation 26.44 |
| Flexibility Exercise Group | Visual Analog Scale of Low Back Pain During Rest | 32.50 score on a scale | Standard Deviation 21.79 |
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Exercise Group | Depression Scale | Pre-exercise | 10.5 score on a scale | Standard Deviation 7.3 |
| Walking Exercise Group | Depression Scale | After 6 weeks | 8.6 score on a scale | Standard Deviation 7.1 |
| Stabilization Exercise Group | Depression Scale | After 6 weeks | 5.3 score on a scale | Standard Deviation 6.2 |
| Stabilization Exercise Group | Depression Scale | Pre-exercise | 7.2 score on a scale | Standard Deviation 4.8 |
| Walking and Stabilization Exercise Group | Depression Scale | After 6 weeks | 10.7 score on a scale | Standard Deviation 9.2 |
| Walking and Stabilization Exercise Group | Depression Scale | Pre-exercise | 13.3 score on a scale | Standard Deviation 11.9 |
| Flexibility Exercise Group | Depression Scale | Pre-exercise | 12.3 score on a scale | Standard Deviation 7.6 |
| Flexibility Exercise Group | Depression Scale | After 6 weeks | 10.8 score on a scale | Standard Deviation 6.7 |
Secondary
Muscle Strength(Endurance)
endurances of specific posture (sec) (supine, side-lying and prone)
Time frame: Baseline Pre-Exercise and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Walking Exercise Group | Muscle Strength(Endurance) | Pre-exercise | 29.86 second | Standard Deviation 13.53 |
| Walking Exercise Group | Muscle Strength(Endurance) | After 6 weeks | 43.30 second | Standard Deviation 18.83 |
| Stabilization Exercise Group | Muscle Strength(Endurance) | After 6 weeks | 45.06 second | Standard Deviation 14.01 |
| Stabilization Exercise Group | Muscle Strength(Endurance) | Pre-exercise | 51.45 second | Standard Deviation 12.4 |
| Walking and Stabilization Exercise Group | Muscle Strength(Endurance) | Pre-exercise | 35.14 second | Standard Deviation 20.64 |
| Walking and Stabilization Exercise Group | Muscle Strength(Endurance) | After 6 weeks | 43.79 second | Standard Deviation 17.81 |
| Flexibility Exercise Group | Muscle Strength(Endurance) | Pre-exercise | 41.25 second | Standard Deviation 15.31 |
| Flexibility Exercise Group | Muscle Strength(Endurance) | After 6 weeks | 50.06 second | Standard Deviation 16.65 |