Low Back PainNCT02938689
Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
A study testing Exercise in people with Low Back Pain, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2016to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic low back pain (>6 months, VAS score of 5 or above)
- presence of discogenic or axial pain
- duration of >6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Exercise
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Lumbar extension exercise | Experimental | Exercise education based on Mckenzie lumbar extension exercise for 4 weeks Receives: Other: Exercise |
| Lumbar flextion exercise | Active comparator | Exercise education based on Wilillams lumbar flexion exercise for 4 weeks Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Back pain VAS score (0~10) at 12 month
Describe the degree of pain by VAS score
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
Secondary outcomes (5)
brief pain inventory (right now pain, worst pain, least pain, pain interference)
Describe the degree of pain by survey
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
Oswestry Disability Questionnaire
Describe the degree of pain by survey
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
EQ-5D
Describe the health-related quality of life
Measured: Baseline, Month 1, Month 3, Month 6, Month 12
PASE
Describe the status of physical activity
Measured: 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
Measured: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start27 Oct 2016
- Primary completion30 Sep 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Gun Chung, Seoul National University Hospital
- Investigators
- Sun Gun Chung, MD. PhD, Study chair, Department of Rehabilitation Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938689
- Sponsor's protocol ID
- SNUH-1607-199-782
- Status last verified
- Dec 2021
- First submitted
- 11 Oct 2016
- Last updated
- 4 Jan 2022
- Results posted
- No
Publications
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.
PubMed 38302483
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison of the Exercises Based on the Lumbar Extension and Flexion in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02938689
- Acronym / sponsor ID
- SNUH-1607-199-782
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar extension exercise | Experimental | Other: ExerciseExercise education based on Mckenzie lumbar extension exercise for 4 weeks |
| Lumbar flextion exercise | Active comparator | Other: ExerciseExercise education based on Wilillams lumbar flexion exercise for 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic low back pain (>6 months, VAS score of 5 or above)
- presence of discogenic or axial pain
- duration of >6 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Other | Lumbar extension exercise, Lumbar flextion exercise |
Primary outcome
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
5 secondary outcomes
brief pain inventory (right now pain, worst pain, least pain, pain interference)
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
Oswestry Disability Questionnaire
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
EQ-5D
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
PASE
Time frame: Baseline, Month 1, Month 3, Month 6, Month 12
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Derived from this study: PubMed 38302483Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Gun Chung, MD. PhD study chair
Department of Rehabilitation Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Low Back Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Back pain VAS score (0~10) at 12 month (time frame: Baseline, Month 1, Month 3, Month 6, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02938689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.