Low Back PainNCT02089321
Multiplanar Lumbopelvic Control in Patients With Low Back Pain
An observational study of Low Back Pain, run by Regis University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Keywords
- low back pain, lumbopelvic assessment, active straight leg raise, active hip abduction
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed on data collection day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Nelson-Wong, Regis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089321
- Sponsor's protocol ID
- NelsonWong_LBP2013
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiplanar Lumbopelvic Control in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT02089321
- Acronym / sponsor ID
- NelsonWong_LBP2013
- Conditions
- Low Back Pain
- Keywords
- low back pain, lumbopelvic assessment, active straight leg raise, active hip abduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Regis UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance on Active Hip Abduction Test
Time frame: Assessed on data collection day
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.
Performance on Active Straight Leg Raise Test
Time frame: Assessed on data collection day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Regis University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on Active Hip Abduction Test (time frame: Assessed on data collection day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.