Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Oct 2016
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2016
CompletedFirst Posted
Study publicly available on registry
October 19, 2016
CompletedStudy Start
First participant enrolled
October 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 4, 2022
December 1, 2021
1.9 years
October 11, 2016
December 13, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Average Back pain VAS score (0~10) at 12 month
Describe the degree of pain by VAS score
Baseline, Month 1, Month 3, Month 6, Month 12
Secondary Outcomes (5)
brief pain inventory (right now pain, worst pain, least pain, pain interference)
Baseline, Month 1, Month 3, Month 6, Month 12
Oswestry Disability Questionnaire
Baseline, Month 1, Month 3, 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
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
Study Arms (2)
Lumbar extension exercise
EXPERIMENTALExercise education based on Mckenzie lumbar extension exercise for 4 weeks
Lumbar flextion exercise
ACTIVE COMPARATORExercise education based on Wilillams lumbar flexion exercise for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- chronic low back pain (\>6 months, VAS score of 5 or above)
- presence of discogenic or axial pain
- duration of \>6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Park CH, Beom J, Chung CK, Kim CH, Lee MY, Park MW, Kim K, Chung SG. Long-term effects of lumbar flexion versus extension exercises for chronic axial low back pain: a randomized controlled trial. Sci Rep. 2024 Feb 1;14(1):2714. doi: 10.1038/s41598-024-51769-2.
PMID: 38302483DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sun Gun Chung, MD. PhD
Department of Rehabilitation Medicine, Seoul National University Hospital
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
- Professor
Study Record Dates
First Submitted
October 11, 2016
First Posted
October 19, 2016
Study Start
October 27, 2016
Primary Completion
September 30, 2018
Study Completion
December 31, 2020
Last Updated
January 4, 2022
Record last verified: 2021-12