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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Exercise

• Registration Number: NCT02938689
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-19
• Study Start: 2016-10-27
• Primary Completion: 2018-09-30
• Study Completion: 2020-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar extension exercise	Exercise	Exercise education based on Mckenzie lumbar extension exercise for 4 weeks
Lumbar flextion exercise	Exercise	Exercise education based on Wilillams lumbar flexion exercise for 4 weeks

Primary Outcome Measures

Name	Time	Method
Average Back pain VAS score (0~10) at 12 month	Baseline, Month 1, Month 3, Month 6, Month 12	Describe the degree of pain by VAS score

Secondary Outcome Measures

Name	Time	Method
brief pain inventory (right now pain, worst pain, least pain, pain interference)	Baseline, Month 1, Month 3, Month 6, Month 12	Describe the degree of pain by survey
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	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
EQ-5D	Baseline, Month 1, Month 3, Month 6, Month 12	Describe the health-related quality of life
PASE	Baseline, Month 1, Month 3, Month 6, Month 12	Describe the status of physical activity
Oswestry Disability Questionnaire	Baseline, Month 1, Month 3, Month 6, Month 12	Describe the degree of pain by survey

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of