NCT02089321

Brief Summary

The purpose of this study was to investigate whether combined assessment of lumbopelvic control during sagittal and frontal plane motion (using two common clinical observational assessments) discriminates between people with and without LBP than single plane assessment alone. It was hypothesized that the two tests used in combination (multiplanar) would perform better than each test used independently (single planar) in accurately discriminating patient cases from healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

March 13, 2014

Last Update Submit

March 13, 2014

Conditions

Keywords

low back painlumbopelvic assessmentactive straight leg raiseactive hip abduction

Outcome Measures

Primary Outcomes (2)

  • Performance on Active Hip Abduction Test

    Examiner scores movement pattern (ability to retain lumbopelvic neutral) during performance of active hip abduction in sidelying using an ordinal scale (0-3) with 0-1 considered a negative test and 2-3 considered a positive test.

    Assessed on data collection day

  • Performance on Active Straight Leg Raise Test

    Participant self-rates degree of difficulty (0-5) to perform active straight leg raise in supine with any non-zero score considered a positive test result.

    Assessed on data collection day

Study Arms (2)

Patients with Low Back Pain

n= 19 Inclusion Criteria: Between the ages of 18 and 70 years Currently seeking, but not yet initiated, treatment from a health care professional (PT, MD, DO, DC) for a chief complaint of pain between the level of the twelfth thoracic vertebrae and the coccyx Able to transition between standing, sitting, supine, prone and sidelying independently Exclusion Criteria: Signs of neurological impairment including diminished myotatic reflex, sensory impairment or strength deficits in a myotomal pattern No previous spine or hip surgery Serious spinal or systemic pathology Pregnancy within previous 12 months Inability to understand and follow verbal instructions in English

Healthy Controls

n= 19 Inclusion Criteria: Between the ages of 18 and 70 years No LBP episodes requiring clinical care by a health professional and/or greater than 3 days absence from work/school/recreation within the previous 5 years Able to transition between standing, sitting, supine, prone and sidelying independently Exclusion Criteria: No previous spine or hip surgery Serious spinal or systemic pathology Pregnancy within previous 12 months Inability to understand and follow verbal instructions in English

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with low back pain were recruited from the physical therapy clinic located at Regis University as well as clinical practices from the surrounding area. Control subjects were a community sample.

You may qualify if:

  • Patients with LBP
  • Age 18-70 years old
  • Ability to understand and follow written and verbal instruction in English
  • Seeking treatment from a physical therapist for LBP (pain below T12-L1 vertebral segment), prior to initial evaluation (no treatment provided)
  • Matched Controls: Control subjects will be matched for age, gender, and BMI category to patients with LBP.
  • Ability to understand and follow written and verbal instruction in English
  • No history of LBP during the past 5 years requiring:
  • \> 3 day absence from work/school/recreation
  • Clinical Care (MD, DC, DPT, MT) for LBP

You may not qualify if:

  • Patients with LBP
  • Pregnancy within past 12 months
  • Previous spine or hip surgery
  • Serious spinal or systemic pathology
  • Inability to transfer from standing to supine to sidelying to prone
  • Inability to stand \> 20 minutes
  • Matched Controls
  • Pregnancy within the past 12 months
  • Previous spine or hip surgery
  • Inability to transfer from standing to supine to side-lying to prone
  • Inability to stand \> 20 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 17, 2014

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations