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Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Exercise
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic low back pain (>6 months, VAS score of 5 or above)
  • presence of discogenic or axial pain
  • duration of >6 months

Exclusion Criteria:

  • Spondylolisthesis or retrolisthesis on radiograph
  • Hx of spine surgery
  • Hx of any spine intervention within 3 months
  • other neurological, inflammatory, or poor medical conditions
  • who cannot understand or conduct the protocol of the study

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbar extension exercise

Lumbar flextion exercise

Arm Description

Exercise education based on Mckenzie lumbar extension exercise for 4 weeks

Exercise education based on Wilillams lumbar flexion exercise for 4 weeks

Outcomes

Primary Outcome Measures

Average Back pain VAS score (0~10) at 12 month
Describe the degree of pain by VAS score

Secondary Outcome Measures

brief pain inventory (right now pain, worst pain, least pain, pain interference)
Describe the degree of pain by survey
Oswestry Disability Questionnaire
Describe the degree of pain by survey
EQ-5D
Describe the health-related quality of life
PASE
Describe the status of physical activity
How often did the subject conduct exercise in the past a month? (5 levels)
3 times or more a day once or twice a day 4 times or more a week, but less than once a day 1-3 times a week less than once a week

Full Information

First Posted
October 11, 2016
Last Updated
December 13, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02938689
Brief Title
Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
Official Title
Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
This study is to compare the efficacy of exercises based on the lumbar extension and flexion on the pain relief and the prevention of pain recurrence in chronic low back pain patients.
Detailed Description
68 people that meet the inclusion criteria on screening test are assigned to one of two groups by randomization. Each of the group learns one of the exercises based on the lumbar extension or flexion for four weeks. The main outcome variables are measured and compared respectively in baseline, immediately after the education, 3, 6, 12 months after the enrollment. Finally lumbar extension exercise is verified whether it is more effective than the lumbar flexion exercise on the pain relief and the prevention of pain recurrence in chronic low back pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar extension exercise
Arm Type
Experimental
Arm Description
Exercise education based on Mckenzie lumbar extension exercise for 4 weeks
Arm Title
Lumbar flextion exercise
Arm Type
Active Comparator
Arm Description
Exercise education based on Wilillams lumbar flexion exercise for 4 weeks
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Average Back pain VAS score (0~10) at 12 month
Description
Describe the degree of pain by VAS score
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Secondary Outcome Measure Information:
Title
brief pain inventory (right now pain, worst pain, least pain, pain interference)
Description
Describe the degree of pain by survey
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Title
Oswestry Disability Questionnaire
Description
Describe the degree of pain by survey
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Title
EQ-5D
Description
Describe the health-related quality of life
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Title
PASE
Description
Describe the status of physical activity
Time Frame
Baseline, Month 1, Month 3, Month 6, Month 12
Title
How often did the subject conduct exercise in the past a month? (5 levels)
Description
3 times or more a day once or twice a day 4 times or more a week, but less than once a day 1-3 times a week less than once a week
Time Frame
Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic low back pain (>6 months, VAS score of 5 or above) presence of discogenic or axial pain duration of >6 months Exclusion Criteria: Spondylolisthesis or retrolisthesis on radiograph Hx of spine surgery Hx of any spine intervention within 3 months other neurological, inflammatory, or poor medical conditions who cannot understand or conduct the protocol of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun Gun Chung, MD. PhD
Organizational Affiliation
Department of Rehabilitation Medicine, Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain

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