Low Back PainNCT03121703
The Effects of Lumbar Stabilization Exercise on Transversus Abdominis Muscle Activation Capacity and Function in Chronic Low Back Pain Patients
A study testing lumbar stabilization exercise and trunk muscle strengthening exercise in people with Low Back Pain, run by Inje University.
Trial summary
Purpose: The purpose of this study is to investigate the effects of lumbar stabilization exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity, functional disability, and TrA thickness in patients with chronic low back pain (CLBP). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- lumbar stabilization exercise and trunk muscle strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 30 Jun 2017
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who felt low back pain
Who cannot join
- Orthopedic surgery within 6 months
About this study
Official title: Main Researcher for Effects of Lumbar Stabilization Exercise on Transversus Abdominis Muscle Activation Capacity and Function in Chronic Low Back Pain Patients
Purpose: The purpose of this study is to investigate the effects of lumbar stabilization exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity, functional disability, and TrA thickness in patients with chronic low back pain (CLBP). Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group performed diverse lumbar stabilization exercises in different postures, and the control group conducted an ordinary trunk muscle strengthening exercise. Results: There were significant differences in pain intensity, TrA activation capacity, functional disability, and TrA thickness between before and after the intervention in both groups. Significant differences between the two groups were shown in the pain intensity, TrA activation capacity, and functional disability after the intervention. However, there were no significant differences between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in different postures could reduce pain, functional disability, and increase TrA activation capacity and thickness in CLBP patients.
- Conditions
- Low Back Pain
- Being tested
- lumbar stabilization exercise, trunk muscle strengthening 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.
lumbar stabilization exerciseOther
lumbar stabilization exercise
trunk muscle strengthening exerciseOther
trunk muscle strengthening exercise
| Study group | Role | What they receive |
|---|---|---|
| lumbar stabilization exercises group | Experimental | diverse lumbar stabilization exercises Receives: Other: lumbar stabilization exercise |
| trunk muscle strengthening exercise | Other | trunk muscle strengthening exercise Receives: Other: trunk muscle strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
transverse abdominis thickness
ultrasound image for measuring transverse abdominis thickness
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start1 May 2017 (estimated)
- Primary completion30 May 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do hyun Kim, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121703
- Sponsor's protocol ID
- InjeU 1
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Researcher for Effects of Lumbar Stabilization Exercise on Transversus Abdominis Muscle Activation Capacity and Function in Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT03121703
- Acronym / sponsor ID
- InjeU 1
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 30 May 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 20 Apr 2017 (actual)
- 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.
Purpose: The purpose of this study is to investigate the effects of lumbar stabilization exercises on pain intensity, transversus abdominis muscle (TrA) activation capacity, functional disability, and TrA thickness in patients with chronic low back pain (CLBP). Subjects: The subjects of this study were 30 CLBP patients. Methods: The experimental group performed diverse lumbar stabilization exercises in different postures, and the control group conducted an ordinary trunk muscle strengthening exercise. Results: There were significant differences in pain intensity, TrA activation capacity, functional disability, and TrA thickness between before and after the intervention in both groups. Significant differences between the two groups were shown in the pain intensity, TrA activation capacity, and functional disability after the intervention. However, there were no significant differences between the two groups in TrA thickness. Conclusion: Lumbar stabilization exercises in different postures could reduce pain, functional disability, and increase TrA activation capacity and thickness in CLBP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar stabilization exercises group | Experimental | Other: lumbar stabilization exercisediverse lumbar stabilization exercises |
| trunk muscle strengthening exercise | Other | Other: trunk muscle strengthening exercisetrunk muscle strengthening exercise |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who felt low back pain
Key exclusion criteria (1 listed)
- Orthopedic surgery within 6 months
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 |
|---|---|---|
| lumbar stabilization exerciselumbar stabilization exercise | Other | lumbar stabilization exercises group |
| trunk muscle strengthening exercisetrunk muscle strengthening exercise | Other | trunk muscle strengthening exercise |
Primary outcome
transverse abdominis thickness
Time frame: 1 year
ultrasound image for measuring transverse abdominis thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar stabilization exercise and trunk muscle strengthening exercise in people with Low Back Pain, run by Inje University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
transverse abdominis thickness (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.