Trial Outcomes & Findings for The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis (NCT NCT02938169)
NCT ID: NCT02938169
Last Updated: 2020-11-12
Results Overview
numerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Baseline Pre-Exercise and 6 weeks
Results posted on
2020-11-12
Participant Flow
Participant milestones
| Measure |
Walking Exercise Group
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
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.
|
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
|
Flexibility Exercise Group
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Baseline characteristics by cohort
| Measure |
Walking Exercise Group
n=13 Participants
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
Stabilization Exercise Group
n=10 Participants
\*\* 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 and Stabilization Exercise Group
n=12 Participants
\*\*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
|
Flexibility Exercise Group
n=13 Participants
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.15 years
STANDARD_DEVIATION 13.89 • n=5 Participants
|
57.40 years
STANDARD_DEVIATION 15.88 • n=7 Participants
|
54.75 years
STANDARD_DEVIATION 14.98 • n=5 Participants
|
53.54 years
STANDARD_DEVIATION 15.69 • n=4 Participants
|
54.81 years
STANDARD_DEVIATION 14.66 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
South Korea
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline Pre-Exercise and 6 weeksnumerical rating scale (NRS) (Unit: Point) Subjects indicate pain in columns 0 (no pain) to 100 (uncontrollable pain).
Outcome measures
| Measure |
Walking Exercise Group
n=13 Participants
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
Stabilization Exercise Group
n=10 Participants
\*\* 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."
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
|
Walking and Stabilization Exercise Group
n=12 Participants
\*\*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
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
|
Flexibility Exercise Group
n=13 Participants
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
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
* flexibility exercise: stretching exercise(control)
|
|---|---|---|---|---|
|
Low Back Pain at Resting Status
After 6 weeks
|
25.00 score on a scale
Standard Deviation 20.10
|
24.25 score on a scale
Standard Deviation 20.21
|
18.33 score on a scale
Standard Deviation 20.93
|
27.89 score on a scale
Standard Deviation 18.54
|
|
Low Back Pain at Resting Status
Pre-exercise
|
30.58 score on a scale
Standard Deviation 20.92
|
37.50 score on a scale
Standard Deviation 21.76
|
30.00 score on a scale
Standard Deviation 30.38
|
41.92 score on a scale
Standard Deviation 23.32
|
PRIMARY outcome
Timeframe: Baseline Pre-Exercise and 6 weeksOswestry 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.\[
Outcome measures
| Measure |
Walking Exercise Group
n=13 Participants
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
Stabilization Exercise Group
n=10 Participants
\*\* 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."
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
|
Walking and Stabilization Exercise Group
n=12 Participants
\*\*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
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
|
Flexibility Exercise Group
n=13 Participants
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
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
* flexibility exercise: stretching exercise(control)
|
|---|---|---|---|---|
|
Disability for Low Back Pain
Pre-exercise
|
28.1 score on a scale
Standard Deviation 12.8
|
31.4 score on a scale
Standard Deviation 13.2
|
30.4 score on a scale
Standard Deviation 12.9
|
38.0 score on a scale
Standard Deviation 21.1
|
|
Disability for Low Back Pain
After 6 weeks
|
22.5 score on a scale
Standard Deviation 7.4
|
25.3 score on a scale
Standard Deviation 9.9
|
24.9 score on a scale
Standard Deviation 12.3
|
31.9 score on a scale
Standard Deviation 18.6
|
PRIMARY outcome
Timeframe: 0 week to 6weeksvisual 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'
Outcome measures
| Measure |
Walking Exercise Group
n=13 Participants
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
Stabilization Exercise Group
n=10 Participants
\*\* 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."
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
|
Walking and Stabilization Exercise Group
n=12 Participants
\*\*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
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
|
Flexibility Exercise Group
n=13 Participants
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
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
* flexibility exercise: stretching exercise(control)
|
|---|---|---|---|---|
|
Visual Analog Scale of Low Back Pain During Rest
|
20.00 score on a scale
Standard Deviation 17.58
|
22.50 score on a scale
Standard Deviation 23.72
|
20.83 score on a scale
Standard Deviation 26.44
|
32.50 score on a scale
Standard Deviation 21.79
|
SECONDARY outcome
Timeframe: Baseline Pre-Exercise and 6 weeksendurances of specific posture (sec) (supine, side-lying and prone)
Outcome measures
| Measure |
Walking Exercise Group
n=13 Participants
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
Stabilization Exercise Group
n=10 Participants
\*\* 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."
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
|
Walking and Stabilization Exercise Group
n=12 Participants
\*\*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
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
|
Flexibility Exercise Group
n=13 Participants
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
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
* flexibility exercise: stretching exercise(control)
|
|---|---|---|---|---|
|
Muscle Strength(Endurance)
Pre-exercise
|
29.86 second
Standard Deviation 13.53
|
51.45 second
Standard Deviation 12.40
|
35.14 second
Standard Deviation 20.64
|
41.25 second
Standard Deviation 15.31
|
|
Muscle Strength(Endurance)
After 6 weeks
|
43.30 second
Standard Deviation 18.83
|
45.06 second
Standard Deviation 14.01
|
43.79 second
Standard Deviation 17.81
|
50.06 second
Standard Deviation 16.65
|
SECONDARY outcome
Timeframe: 6 weeksBeck 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.
Outcome measures
| Measure |
Walking Exercise Group
n=13 Participants
\*\*walking exercise
•walking exercise: treadmill gait with tolerable gait speed
|
Stabilization Exercise Group
n=10 Participants
\*\* 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."
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
|
Walking and Stabilization Exercise Group
n=12 Participants
\*\*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
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
|
Flexibility Exercise Group
n=13 Participants
\*\*Stretching exercise(control)
* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method
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
* flexibility exercise: stretching exercise(control)
|
|---|---|---|---|---|
|
Depression Scale
Pre-exercise
|
10.5 score on a scale
Standard Deviation 7.3
|
7.2 score on a scale
Standard Deviation 4.8
|
13.3 score on a scale
Standard Deviation 11.9
|
12.3 score on a scale
Standard Deviation 7.6
|
|
Depression Scale
After 6 weeks
|
8.6 score on a scale
Standard Deviation 7.1
|
5.3 score on a scale
Standard Deviation 6.2
|
10.7 score on a scale
Standard Deviation 9.2
|
10.8 score on a scale
Standard Deviation 6.7
|
Adverse Events
Walking Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stabilization Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Walking and Stabilization Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Flexibility Exercise Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Juseok Ryu
Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
Phone: +82-10-4382-2328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place