Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion View
Primary Purpose
Low Back Pain, Spondylolisthesis
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Slump sitting
Forward bending
Sponsored by
About this trial
This is an interventional diagnostic trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous spinal interventions
- Suspected findings for spinal malignancies, spinal trauma, and inflammatory spinal diseases
- Pregnant women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Slump sitting
Forward bending
Arm Description
Slump sitting flexion of lumbar spine
Forward erect bending of lumbar spine
Outcomes
Primary Outcome Measures
Global lumbar spine flexion range of motion
Change in mean global lumbar spine flexion between sitting and standing postures
Secondary Outcome Measures
Segmental lumbar spine flexion range of motion
Change in segmental global lumbar spine flexion between sitting and standing postures
Segmental translational changes during lumbar spine flexion
Percentage translation at each segmental lumbar spine levels
Full Information
NCT ID
NCT02547324
First Posted
August 20, 2015
Last Updated
September 9, 2015
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02547324
Brief Title
Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion View
Official Title
Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Study results were too significant
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Spondylolisthesis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Slump sitting
Arm Type
Experimental
Arm Description
Slump sitting flexion of lumbar spine
Arm Title
Forward bending
Arm Type
Active Comparator
Arm Description
Forward erect bending of lumbar spine
Intervention Type
Radiation
Intervention Name(s)
Slump sitting
Intervention Description
Patients are asked to sit slumped on the chair as much as possible without leaning forwards, and place you hands below your thighs.
Intervention Type
Radiation
Intervention Name(s)
Forward bending
Intervention Description
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
Primary Outcome Measure Information:
Title
Global lumbar spine flexion range of motion
Description
Change in mean global lumbar spine flexion between sitting and standing postures
Time Frame
Day 1 (no follow-up, outcome assessed immediately)
Secondary Outcome Measure Information:
Title
Segmental lumbar spine flexion range of motion
Description
Change in segmental global lumbar spine flexion between sitting and standing postures
Time Frame
Day 1 (no follow-up, outcome assessed immediately)
Title
Segmental translational changes during lumbar spine flexion
Description
Percentage translation at each segmental lumbar spine levels
Time Frame
Day 1 (no follow-up, outcome assessed immediately)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Previous spinal interventions
Suspected findings for spinal malignancies, spinal trauma, and inflammatory spinal diseases
Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Kit Wong, MBBS
Organizational Affiliation
National University Health System
Official's Role
Study Chair
12. IPD Sharing Statement
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Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion View
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