Plain English Summary
Background and study aims
Spinal physicians and physical therapist perform many tests to identify those who might suffer from specific low back pain due to inability of the back muscles and ligaments to control spinal movements during daily life activities. In this study we want to know how much we can rely on these test to reach the same diagnostic conclusion between different examiners. By performing these tests, will the examiners reach the same clinical decision making? If yes, the tests are reliable. If no, then we cannot rely on these test for clinical decision making.
Who can participate?
Adults suffering from lower back pain.
What does the study involve?
Examiners performing a series of tests.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Loma Linda University (USA)
When is the study starting and how long is it expected to run for?
February 2013 to June 2013
Who is funding the study?
Loma Linda University (USA)
Who is the main contact?
Faisal Alyazedi
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Inter-Rater Reliability of Clinical Tests That Best Predict the Sub-classification of Lumbar Segmental Instability: Structural, Functional, and Combined Instability: a cross sectional study
Acronym
Study hypothesis
The purpose of the study is to identify the inter-rater reliability of examiners performing clinical instability tests in order to identify different instability subgroups (structural, functional, and combined).
Ethics approval
Loma Linda University’s Institutional Review Board IRB# 5120285, 30/11/2012
The contact information of the Research Protection Programs is:
24887 Taylor Street, Suite 202, Loma Linda, CA 92350, USA
+1 (909) 558- 4531 (Voice). +1 (909) 558- 0131 (Fax)
Study design
Cross-Sectional Test-Retest Design
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Schools
Trial type
Diagnostic
Patient information sheet
Condition
Subjects with recurrent or chronic low-back pain (LBP)
Intervention
There was no intervention at all. Study conducted in the Physical Therapy Research Laboratory at Loma Linda University (USA).
Two examiners performed the six most validated clinical lumbar segmental instability tests- defined by highest +LR- on the subjects who had recurrent or chronic LBP, then sub-classify the subjects on three different lumbar segmental instability categories depending on the test results. We want to know if there is constancy in the decision making between the raters about the test results and the sub-classification. The tests are as follow:
• Passive lumbar extension test.
• Lumbar flexion ROM (> 53°) test.
• Lack of hypomobility with PA glide.
• Prone instability test (PIT)
• Aberrant motion present
• Average SLR (>91°)
Intervention type
Other
Phase
Drug names
Primary outcome measure
Kappa coefficient values for inter-rater reliability between the two examiners
The prevalence-adjusted, bias-adjusted Kappa (PABAK) values
Secondary outcome measures
The Baseline Measures (patients’ characteristics) were collected at the beginning of the study, which included:
• the Numeric Pain Rating Scale (NPRS)
• the Modified Oswestry Low-back Pain Disability Questionnaire (OSW)
• and the Fear Avoidance Beliefs Questionnaire (FABQ)
Overall trial start date
04/02/2013
Overall trial end date
11/06/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients who have a new episode of LBP
2. Experienced a similar episode of LBP before, with the first episode of back pain occurring at least three months before the date of recruitment
3. Experienced persistent LBP for at least three months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 subjects
Participant exclusion criteria
1. Patients who have undergone previous spinal-fusion surgery
2. History of traumatic fracture of the spine that resulted in a permanent neurological deficit
3. Scoliosis greater than 20°
4. Pregnancy
5. Inability to actively flex and extend the spine adequately to permit an assessment of segmental motion due to pain or muscle spasm
6. Medical “red flags” such as caudaequina syndrome, tumor, and systemic inflammatory conditions
Recruitment start date
04/02/2013
Recruitment end date
11/06/2013
Locations
Countries of recruitment
United States of America
Trial participating centre
Loma Linda University
School Of Allied Health Profession, Department Of Physical Therapy, Nichol Hall,
Loma Linda
92350
United States of America
Funders
Funder type
University/education
Funder name
Loma Linda University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Submission to Journal of Manual and Manipulative therapy JMMT
Intention to publish date
31/12/2015
Participant level data
Available on request
Basic results (scientific)
Publication list