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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: exercise

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungji-do
    • Seongnam-si, Kyungji-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Juseok Ryu, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): April 30, 2017

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (ESTIMATE): October 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: exercise; low back pain; electromyography
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: B-1604-344-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO