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

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ClinicalTrials.gov Identifier: NCT02938169
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ju Seok Ryu, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: exercise Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Study Start Date : May 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: walking exercise group

**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
  • 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)

Experimental: stabilization exercise group

** 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
  • 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)

Experimental: walking and stabilization exercise group

**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
  • 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)

Sham Comparator: flexibility exercise group

**Stretching exercise(control)

  • Only educate the flexibility exercise(stretching exercise)
  • Don't educate the walking exercise method and stabilization exercise method
Behavioral: 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)




Primary Outcome Measures :
  1. Pain [ Time Frame: 6 weeks ]
    numerical rating scale (NRS) (Unit: Point)

  2. Disability for low back pain [ Time Frame: 6 weeks ]
    Oswestry disability index(ODI) (Unit: Point)


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: 6 weeks ]
    peak torque by surface electromyography (Unit: N*m)

  2. Muscle endurance [ Time Frame: 6 weeks ]
    Time duration of capability of maintenance the posture Time duration of capability of maintenance the posture Time duration of maintenance of the posture(Unit: second)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938169


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Sungnam, Kyungji-do, Korea, Republic of, 13620
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Juseok Ryu, MD, PhD Seoul National University Bundang Hospital

Publications of Results:
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Responsible Party: Ju Seok Ryu, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02938169     History of Changes
Other Study ID Numbers: B-1604-344-004
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ju Seok Ryu, Seoul National University Hospital:
low back pain
surface EMG
exercise
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms