Low Back PainNCT02547324
Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion View
A study testing Slump sitting and Forward bending in people with Low Back Pain and Spondylolisthesis, run by National University Hospital, Singapore.
Trial summary
This is a prospective, single-blinded, randomized-controlled study comparing a new method (slump-sitting) with the conventional method (forward erect bending) of performing lumbar spine flexion X-rays. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Low Back Pain, Spondylolisthesis
- What is being tested?
- Slump sitting and Forward bending
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2014to May 2015
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 45 years of age;
- With mechanical low back pain,
- With spondylolisthesis
- Physically able to position themselves correctly for both methods of X-rays
Who cannot join
- Previous spinal interventions
- Suspected findings for spinal malignancies, spinal trauma, and inflammatory spinal diseases
- Pregnant women
About this study
Official title: Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion
This is a prospective, single-blinded, randomized-controlled study comparing a new method (slump-sitting) with the conventional method (forward erect bending) of performing lumbar spine flexion X-rays.
Read the detailed description
Power calculation was performed based on preliminary pilot results using a clinically set difference of 10 degrees (SD 15 degrees) change in mean global lumbar spine flexion between sitting and standing postures. An estimated sample population of 100 patients was deemed necessary for this study to fulfill a statistical power of 90% and a two-sided 5% significance level.
Block randomization of every 4 subjects was performed at the beginning of the study to ensure equal numbers of subjects in both study arms for comparison and these results were concealed in envelopes.
During the clinical consult, history taking was performed as per a usual clinic visit. Specific patient's details including age, occupation, presence and severity of back pain, presence and severity of leg pain, and neurological symptoms were documented. Physical examination was performed accordingly and parameters such as clinical range of motion of the lumbar spine, neurological signs and provocative tests were recorded for later analysis.
For the flexion radiographs, both the new and conventional methods were performed on each patient. These pictures were made into charts and visually displayed. They serve as instructional manuals for patients during the radioimaging process, which are again reinforced with verbal instructions from the on-duty radiographers.
Both images were done with the X-ray beam projected from the patients's left and at a distance of 100cm from the patient. The central beam was directed at the estimated centre of L3, with T11 vertebral body and mid-body of the sacrum serving as superior and inferior limits respectively. A single extension view of the lumbar spine was also performed after these flexion views. All radiographs were stored on Digital Imaging and Communications in Medicine (DICOM) format and viewed with Centricity Enterprise Web V3.0 (8.0.1400.128) for assessment.
Measurements were done by 2 independent reviewers and an average of their readings was recorded. Both reviewers were blinded to the method in which flexion X-rays was taken.
Interim data analysis is planned at 30th patient and the 60th patient. During this time point, the primary objective which look at mean global lumbar spine flexion between sitting and standing postures is assessed.
All collected data and measurements were tabulated using Microsoft Excel 2011(Version 14.0 (32-bit)) and analyzed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS Version 23.0).
For the main analysis of both global and segmental lumbar flexion, as well as the measured displacements obtained between the two flexion methods, paired t-test was employed.
There is no requirement to follow up the patients in this study. The whole study is to be completed within 1 year of recruitment
- Conditions
- Low Back Pain, Spondylolisthesis
- Being tested
- Slump sitting, Forward bending
- Medical subject headings
- Low Back Pain, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slump sittingRadiation
Patients are asked to sit slumped on the chair as much as possible without leaning forwards, and place you hands below your thighs.
Forward bendingRadiation
Patients are asked to stand with both feet placed together, hands behind their heads, and bend forward in this position as much as possible without falling
| Study group | Role | What they receive |
|---|---|---|
| Slump sitting | Experimental | Slump sitting flexion of lumbar spine Receives: Radiation: Slump sitting |
| Forward bending | Active comparator | Forward erect bending of lumbar spine Receives: Radiation: Forward bending |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global lumbar spine flexion range of motion
Change in mean global lumbar spine flexion between sitting and standing postures
Measured: Day 1 (no follow-up, outcome assessed immediately)
Secondary outcomes (2)
Segmental lumbar spine flexion range of motion
Change in segmental global lumbar spine flexion between sitting and standing postures
Measured: Day 1 (no follow-up, outcome assessed immediately)
Segmental translational changes during lumbar spine flexion
Percentage translation at each segmental lumbar spine levels
Measured: Day 1 (no follow-up, outcome assessed immediately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Study results were too significant
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.
- More trials run by National University Hospital, SingaporeThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orthosurgery, National University Hospital, Singapore
- Investigators
- Hee-Kit Wong, MBBS, Study chair, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547324
- Sponsor's protocol ID
- 2013/00141
- Status last verified
- Sep 2015
- First submitted
- 20 Aug 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion
- ClinicalTrials.gov ID
- NCT02547324
- Acronym / sponsor ID
- 2013/00141
- Conditions
- Low Back Pain, Spondylolisthesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study results were too significant
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Sep 2015 (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 is a prospective, single-blinded, randomized-controlled study comparing a new method (slump-sitting) with the conventional method (forward erect bending) of performing lumbar spine flexion X-rays.
Detailed description
Power calculation was performed based on preliminary pilot results using a clinically set difference of 10 degrees (SD 15 degrees) change in mean global lumbar spine flexion between sitting and standing postures. An estimated sample population of 100 patients was deemed necessary for this study to fulfill a statistical power of 90% and a two-sided 5% significance level.
Block randomization of every 4 subjects was performed at the beginning of the study to ensure equal numbers of subjects in both study arms for comparison and these results were concealed in envelopes.
During the clinical consult, history taking was performed as per a usual clinic visit. Specific patient's details including age, occupation, presence and severity of back pain, presence and severity of leg pain, and neurological symptoms were documented. Physical examination was performed accordingly and parameters such as clinical range of motion of the lumbar spine, neurological signs and provocative tests were recorded for later analysis.
For the flexion radiographs, both the new and conventional methods were performed on each patient. These pictures were made into charts and visually displayed. They serve as instructional manuals for patients during the radioimaging process, which are again reinforced with verbal instructions from the on-duty radiographers.
Both images were done with the X-ray beam projected from the patients's left and at a distance of 100cm from the patient. The central beam was directed at the estimated centre of L3, with T11 vertebral body and mid-body of the sacrum serving as superior and inferior limits respectively. A single extension view of the lumbar spine was also performed after these flexion views. All radiographs were stored on Digital Imaging and Communications in Medicine (DICOM) format and viewed with Centricity Enterprise Web V3.0 (8.0.1400.128) for assessment.
Measurements were done by 2 independent reviewers and an average of their readings was recorded. Both reviewers were blinded to the method in which flexion X-rays was taken.
Interim data analysis is planned at 30th patient and the 60th patient. During this time point, the primary objective which look at mean global lumbar spine flexion between sitting and standing postures is assessed.
All collected data and measurements were tabulated using Microsoft Excel 2011(Version 14.0 (32-bit)) and analyzed using International Business Machines (IBM) Statistical Package for the Social Sciences (SPSS Version 23.0).
For the main analysis of both global and segmental lumbar flexion, as well as the measured displacements obtained between the two flexion methods, paired t-test was employed.
There is no requirement to follow up the patients in this study. The whole study is to be completed within 1 year of recruitment
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slump sitting | Experimental | Radiation: Slump sittingSlump sitting flexion of lumbar spine |
| Forward bending | Active comparator | Radiation: Forward bendingForward erect bending of lumbar spine |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients above 45 years of age;
- With mechanical low back pain,
- With spondylolisthesis
- Physically able to position themselves correctly for both methods of X-rays
Key exclusion criteria (3 listed)
- Previous spinal interventions
- Suspected findings for spinal malignancies, spinal trauma, and inflammatory spinal diseases
- Pregnant women
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 |
|---|---|---|
| Slump sittingPatients are asked to sit slumped on the chair as much as possible without leaning forwards, and place you hands below your thighs. | Radiation | Slump sitting |
| Forward bendingPatients are asked to stand with both feet placed together, hands behind their heads, and bend forward in this position as much as possible without falling | Radiation | Forward bending |
Primary outcome
Global lumbar spine flexion range of motion
Time frame: Day 1 (no follow-up, outcome assessed immediately)
Change in mean global lumbar spine flexion between sitting and standing postures
2 secondary outcomes
Segmental lumbar spine flexion range of motion
Time frame: Day 1 (no follow-up, outcome assessed immediately)
Segmental translational changes during lumbar spine flexion
Time frame: Day 1 (no follow-up, outcome assessed immediately)
Results and safety
The study was stopped early (reason given: Study results were too significant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
Hee-Kit Wong, MBBS study chair
National University Health System
Questions about this trial
What is this clinical trial studying?
A study testing Slump sitting and Forward bending in people with Low Back Pain and Spondylolisthesis, run by National University Hospital, Singapore.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Sep 2015. 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?
The study was stopped early (reason given: Study results were too significant). 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?
Global lumbar spine flexion range of motion (time frame: Day 1 (no follow-up, outcome assessed immediately)). 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 11 Sep 2015.