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

NCT02938169 | Completed Results DMC

• 1 other identifier: B-1604-344-004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

low back pain; exercise; electromyography

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Muscle Strength(Endurance)

  Baseline Pre-Exercise and 6 weeks

• Depression Scale

  6 weeks

Study Arms (4)

walking exercise group

EXPERIMENTAL

\*\*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 group

EXPERIMENTAL

\*\* 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

walking and stabilization exercise group

EXPERIMENTAL

\*\*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

flexibility exercise group

SHAM COMPARATOR

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

Behavioral: exercise

Interventions

exercise 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; stabilization exercise group; walking and stabilization exercise group; walking exercise group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>20
• Who suffered low back pain more than 3 months.

You may not qualify if:

• Pregnancy
• Under 20-year-old
• Who have significant neurologic deficit
• Who experienced spine operation
• Who cannot walking

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Kyungji-do, 13620, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25122093 RESULT

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Juseok Ryu
• Organization: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

jseok337@snu.ac.kr

+82-10-4382-2328

Study Officials

• Juseok Ryu, MD, PhD

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 19, 2016
• Study Start: May 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: November 12, 2020
• Results First Posted: November 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)