How much we can rely on the specific instability clinical tests to classify low back pain subjects into different instability categories

ISRCTN ISRCTN18037677
DOI https://doi.org/10.1186/ISRCTN18037677
Secondary identifying numbers N/A
Submission date
23/12/2014
Registration date
20/01/2015
Last edited
09/02/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Everett B. Lohman III
Scientific

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

Study information

Study designCross-Sectional Test-Retest Design
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)School
Study typeDiagnostic
Scientific titleThe 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
Study objectivesThe 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(s)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)
Health condition(s) or problem(s) studiedSubjects with recurrent or chronic low-back pain (LBP)
InterventionThere 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 typeOther
Primary outcome measureKappa coefficient values for inter-rater reliability between the two examiners
The prevalence-adjusted, bias-adjusted Kappa (PABAK) values
Secondary outcome measuresThe 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 study start date04/02/2013
Completion date11/06/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 subjects
Total final enrolment40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment04/02/2013
Date of final enrolment11/06/2013

Locations

Countries of recruitment

  • United States of America

Study 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

Loma Linda University
University/education

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

ROR logo "ROR" https://ror.org/04bj28v14

Funders

Funder type

University/education

Loma Linda University

No information available

Results and Publications

Intention to publish date31/12/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planSubmission to Journal of Manual and Manipulative therapy JMMT
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/09/2015 09/02/2023 Yes No

Editorial Notes

09/02/2023: Publication reference added.
02/03/2016: Internal review.