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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02938689
Recruitment Status : Active, not recruiting
First Posted : October 19, 2016
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Exercise Not Applicable

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, 24 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
Actual Study Start Date : October 27, 2016
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lumbar extension exercise
Exercise education based on Mckenzie lumbar extension exercise for 4 weeks
Other: Exercise
Active Comparator: Lumbar flextion exercise
Exercise education based on Wilillams lumbar flexion exercise for 4 weeks
Other: Exercise



Primary Outcome Measures :
  1. Average Back pain VAS score (0~10) during 6 months [ Time Frame: Baseline, Month 6 ]
    Describe the degree of pain by VAS score


Secondary Outcome Measures :
  1. brief pain inventory [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Describe the degree of pain by survey

  2. Oswestry Disability Questionnaire [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Describe the degree of pain by survey

  3. EQ-5D [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Describe the health-related quality of life

  4. whole spine lateral X-ray [ Time Frame: baseline, Month 24 after enrollment ]
    Checking the status of degree of lordosis or any bony abnormalities

  5. Frequency of back pain recurrence [ Time Frame: Month 12, Month 24 after enrollment ]
    Side effect

  6. The number of medication per day taking to reduce low back pain [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Adjusting factor

  7. PASE [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Describe the status of physical activity

  8. Does the subject conduct other exercises rather than the one educated in the study, to reduce low back pain? [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Yes or No

  9. The number of manual therapy for reducing low back pain since last visit [ Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12, Month 24 after enrollment ]
    Adjusting factor

  10. How often did the subject conduct exercise in the past a month? (5 levels) [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12, Month 24 after enrollment ]
    1. 3 times or more a day
    2. once or twice a day
    3. 4 times or more a week, but less than once a day
    4. 1-3 times a week
    5. less than once a week



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938689


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Sun Gun Chung, MD. PhD Department of Rehabilitation Medicine, Seoul National University Hospital
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Responsible Party: Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02938689    
Other Study ID Numbers: SNUH-1607-199-782
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms