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

NCT ID: NCT02938169

Last Updated: 2020-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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* 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

Conditions

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Low Back Pain

Keywords

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low back pain exercise electromyography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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."

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

* 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)

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."

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

* 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)

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

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

* 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)

flexibility exercise group

\*\*Stretching exercise(control)

* Only educate the flexibility exercise(stretching exercise)
* Don't educate the walking exercise method and stabilization exercise method

Group Type SHAM_COMPARATOR

exercise

Intervention Type BEHAVIORAL

* 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)

Interventions

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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)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juseok Ryu, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Kyungji-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type RESULT
PMID: 25122093 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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B-1604-344-004

Identifier Type: -

Identifier Source: org_study_id