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 |
| Protocol serial number | N/A |
| Sponsor | Loma Linda University |
| Funder | Loma Linda University |
- 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
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
Scientific
School Of Allied Health Profession
Department Of Physical Therapy
Nichol Hall
Calfornia
Loma Linda
92350
United States of America
Study information
| Primary study design | Observational |
|---|---|
| Study design | Cross-Sectional Test-Retest Design |
| Secondary study design | Cross sectional study |
| 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Kappa coefficient values for inter-rater reliability between the two examiners |
| Key secondary outcome measure(s) |
The Baseline Measures (patients’ characteristics) were collected at the beginning of the study, which included: |
| Completion date | 11/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/02/2013 |
| Date of final enrolment | 11/06/2013 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Loma Linda
92350
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The 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.
