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Clinical Trials/NCT02938689
NCT02938689
Completed
Not Applicable

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

Seoul National University Hospital1 site in 1 country68 target enrollmentOctober 27, 2016
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Seoul National University Hospital
Enrollment
68
Locations
1
Primary Endpoint
Average Back pain VAS score (0~10) at 12 month
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 27, 2016
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sun Gun Chung

Professor

Seoul National University Hospital

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

Outcomes

Primary Outcomes

Average Back pain VAS score (0~10) at 12 month

Time Frame: Baseline, Month 1, Month 3, Month 6, Month 12

Describe the degree of pain by VAS score

Secondary Outcomes

  • brief pain inventory (right now pain, worst pain, least pain, pain interference)(Baseline, Month 1, Month 3, Month 6, Month 12)
  • How often did the subject conduct exercise in the past a month? (5 levels)(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12)
  • EQ-5D(Baseline, Month 1, Month 3, Month 6, Month 12)
  • PASE(Baseline, Month 1, Month 3, Month 6, Month 12)
  • Oswestry Disability Questionnaire(Baseline, Month 1, Month 3, Month 6, Month 12)

Study Sites (1)

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