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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02938689
• Other study ID #: SNUH-1607-199-782
• Status: Completed
• Phase: N/A
• Start date: October 27, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	brief pain inventory (right now pain, worst pain, least pain, pain interference)	Describe the degree of pain by survey	Baseline, Month 1, Month 3, Month 6, Month 12
Secondary	Oswestry Disability Questionnaire	Describe the degree of pain by survey	Baseline, Month 1, Month 3, Month 6, Month 12
Secondary	EQ-5D	Describe the health-related quality of life	Baseline, Month 1, Month 3, Month 6, Month 12
Secondary	PASE	Describe the status of physical activity	Baseline, Month 1, Month 3, Month 6, Month 12
Secondary	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	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12