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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

Tracking Information
First Submitted Date  ICMJE October 13, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE May 2016
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Pain [ Time Frame: 6 weeks ]
    numerical rating scale (NRS) (Unit: Point)
  • Disability for low back pain [ Time Frame: 6 weeks ]
    Oswestry disability index(ODI) (Unit: Point)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02938169 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Muscle strength [ Time Frame: 6 weeks ]
    peak torque by surface electromyography (Unit: N*m)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
Official Title  ICMJE The Effect of Lumbar Stabilization Exercise and Gait Training on Lower Back Muscles- Electromyographic(EMG) Analysis
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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."
    Intervention: Behavioral: exercise
  • 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."
    Intervention: Behavioral: exercise
  • 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
    Intervention: Behavioral: exercise
  • 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
    Intervention: Behavioral: exercise
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2017
Actual Primary Completion Date April 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938169
Other Study ID Numbers  ICMJE B-1604-344-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ju Seok Ryu, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Juseok Ryu, MD, PhD Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP