Low Back PainCSENSLBPNCT02645760
Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain
A study testing Core stabilization exercise and Conventional treatment in people with Low Back Pain, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to examines the effectiveness of Core stabilization exercise on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core stabilization exercise and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Onset of back pain within 6 -12 weeks participants had no history of back pain for a period of 6 months prior to the current episode.
- Pain intensity measure by a numerical rating scale (0-10 NRS) and a score of pain at least 3 out of 10.
- Never receive the treatment by core stabilization exercise (CSE) during 3 months before participate in this study.
Who cannot join
- Pregnancy
- Onset of serious spinal pathology: spinal fracture, spinal tumor or spinal infection.
- Cauda equina syndrome.
- Presented at least 2 out of 3 signs of neurological deficit
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Associated Medical Sciences, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Comparison of Core Stabilization Exercise and Physical Therapy Treatment in Patients With Subacute Non-specific Low Back Pain
The purpose of this study is to examines the effectiveness of Core stabilization exercise on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain.
Read the detailed description
This study is to compare the effectiveness of Core stabilization exercise and physical therapy on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain. There are 2 groups receiving 2 different kinds of intervention: treatment group receiving core stabilization exercise (CSE) and control group receiving physical therapy including therapeutic ultrasound and hydrocollator pack. Each intervention will perform for 7 weeks. The patients will assess for all outcome measures at baseline, 7 weeks of intervention, and 1- month follow-up
- Conditions
- Low Back Pain
- Being tested
- Core stabilization exercise, Conventional treatment
- 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.
Core stabilization exerciseOther
7-weeks of core stabilization exercise
Conventional treatmentOther
7-weeks of conventional treatment include therapeutic ultrasound and hot pack
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization exercise | Active comparator | 7-weeks of core stabilization exercise Receives: Other: Core stabilization exercise |
| conventional treatment | Active comparator | 7-weeks of conventional treatment include therapeutic ultrasound and hot pack Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7
The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)
Measured: baseline an week 7
Secondary outcomes (3)
Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7
This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score
Measured: baseline and week 7
Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7
Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)
Measured: baseline and week 7
Change From Baseline in Repositioning Error on Repositioning Test at Week 7
This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)
Measured: baseline and week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rungthip Chalermsan, Khon Kaen University
- Investigators
- Rungthip Chalermsan, Study director, Faculty of Associated Medical Sciences, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645760
- Sponsor's protocol ID
- KKU-571H106
- Acronym
- CSENSLBP
- Status last verified
- Dec 2015
- First submitted
- 31 Dec 2015
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Core Stabilization Exercise and Physical Therapy Treatment in Patients With Subacute Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT02645760
- Acronym / sponsor ID
- CSENSLBP / KKU-571H106
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examines the effectiveness of Core stabilization exercise on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain.
Detailed description
This study is to compare the effectiveness of Core stabilization exercise and physical therapy on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain. There are 2 groups receiving 2 different kinds of intervention: treatment group receiving core stabilization exercise (CSE) and control group receiving physical therapy including therapeutic ultrasound and hydrocollator pack. Each intervention will perform for 7 weeks. The patients will assess for all outcome measures at baseline, 7 weeks of intervention, and 1- month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stabilization exercise | Active comparator | Other: Core stabilization exercise7-weeks of core stabilization exercise |
| conventional treatment | Active comparator | Other: Conventional treatment7-weeks of conventional treatment include therapeutic ultrasound and hot pack |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Onset of back pain within 6 -12 weeks participants had no history of back pain for a period of 6 months prior to the current episode.
- Pain intensity measure by a numerical rating scale (0-10 NRS) and a score of pain at least 3 out of 10.
- Never receive the treatment by core stabilization exercise (CSE) during 3 months before participate in this study.
Key exclusion criteria (4 listed)
- Pregnancy
- Onset of serious spinal pathology: spinal fracture, spinal tumor or spinal infection.
- Cauda equina syndrome.
- Presented at least 2 out of 3 signs of neurological deficit
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 |
|---|---|---|
| Core stabilization exercise7-weeks of core stabilization exercise | Other | Core stabilization exercise |
| Conventional treatment7-weeks of conventional treatment include therapeutic ultrasound and hot pack | Other | conventional treatment |
Primary outcome
Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7
Time frame: baseline an week 7
The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)
3 secondary outcomes
Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7
Time frame: baseline and week 7
Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7
Time frame: baseline and week 7
Change From Baseline in Repositioning Error on Repositioning Test at Week 7
Time frame: baseline and week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Rungthip Chalermsan study director
Faculty of Associated Medical Sciences, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization exercise and Conventional treatment in people with Low Back Pain, run by Khon Kaen University at 1 site in Thailand.
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 4 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 6 Oct 2016. 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7 (time frame: baseline an week 7). 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 6 Oct 2016.