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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
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 20, 2015
    Last Updated
    September 9, 2015
    Sponsor
    National University Hospital, Singapore
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    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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