Condition category
Musculoskeletal Diseases
Date applied
23/12/2014
Date assigned
20/01/2015
Last edited
02/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Everett B. Lohman III

ORCID ID

Contact details

School Of Allied Health Profession
Department Of Physical Therapy
Nichol Hall
Calfornia
Loma Linda
92350
United States of America

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 measures

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

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

Sponsor information

Organisation

Loma Linda University

Sponsor details

School Of Allied Health Profession
Department Of Physical Therapy
Nichol Hall
California
Loma Linda
92350
United States of America

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

02/03/2016: Internal review.