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Completed

NCT Number: NCT02938689

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Primary outcomes

  1. 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

  1. brief pain inventory (right now pain, worst pain, least pain, pain interference)

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

    Describe the degree of pain by survey

  2. Oswestry Disability Questionnaire

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

    Describe the degree of pain by survey

  3. EQ-5D

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

    Describe the health-related quality of life

  4. PASE

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

    Describe the status of physical activity

  5. 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

    • 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Oct 19, 2016
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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