NCT02547324

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started May 2014

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

August 20, 2015

Last Update Submit

September 9, 2015

Conditions

Low Back PainSpondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Global lumbar spine flexion range of motion

    Change in mean global lumbar spine flexion between sitting and standing postures

    Day 1 (no follow-up, outcome assessed immediately)

Secondary Outcomes (2)

  • Segmental lumbar spine flexion range of motion

    Day 1 (no follow-up, outcome assessed immediately)

  • Segmental translational changes during lumbar spine flexion

    Day 1 (no follow-up, outcome assessed immediately)

Study Arms (2)

Slump sitting

EXPERIMENTAL

Slump sitting flexion of lumbar spine

Radiation: Slump sitting

Forward bending

ACTIVE COMPARATOR

Forward erect bending of lumbar spine

Radiation: Forward bending

Interventions

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.

Slump sitting
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

Forward bending

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous spinal interventions
  • Suspected findings for spinal malignancies, spinal trauma, and inflammatory spinal diseases
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainSpondylolisthesis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Hee-Kit Wong, MBBS

    National University Health System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Hey Hwee Weng Dennis

Study Record Dates

First Submitted

August 20, 2015

First Posted

September 11, 2015

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

September 11, 2015

Record last verified: 2015-09