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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Exercise

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumbar extension exercise; Exercise education based on Mckenzie lumbar extension exercise for 4 weeks	Other: Exercise
Active Comparator: Lumbar flextion exercise; Exercise education based on Wilillams lumbar flexion exercise for 4 weeks	Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Oswestry Disability Questionnaire	Describe the degree of pain by survey	Baseline, Month 1, Month 3, Month 6, Month 12
EQ-5D	Describe the health-related quality of life	Baseline, Month 1, Month 3, Month 6, Month 12
PASE	Describe the status of physical activity	Baseline, Month 1, Month 3, Month 6, Month 12
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Sun Gun Chung, MD. PhD, Department of Rehabilitation Medicine, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: SNUH-1607-199-782