Chronic Low Back PainNCT02226692
Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain
An observational study of Chronic Low Back Pain and Mechanical Low Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain, Mechanical Low Back Pain
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Sep 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: volunteer with chronic nonspecific low back pain will be recruited among the university's community, its outpatients' chiropractic clinic and through advertisements in the local newspaper. They will first be screened by clinicians at the outpatients' chiropractic clinic in order to assess for the various inclusion and exclusion criteria.
Who may be able to join
- adults between 18 and 60 years old
- nonspecific low back pain : pain located between the twelfth rib and the inferior gluteal fold for which no specific source of pain could be identified
- chronic low back pain : pain present for 12 weeks or more, and included both constant and recurrent patterns of pain
- able to read and understand French
Who cannot join
- History of surgery or major trauma to the spine
- Current use of medication known to impair physical effort and pain perception
- Lumbar scoliosis of more than 20°
- Collagenosis, severe osteoporosis
- Neuromuscular disease
- Malignant tumor
Show all 14Show fewer
- Non-controlled hypertension
- Infection
- Radiculopathy
- Progressive neurologic defect
- Myelopathy
- Lumbar disc hernia
- Pregnancy
- Active lower body injury and/or severe and disabling pain limiting the capacity to undergo the evaluation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G9A 5H7
About this study
Official title: Risk of Poor Prognosis in Patients With Chronic Low Back Pain : Can it be Predicted by Physical Tests and Screening Tools ? - An Observational Study
The aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain. It has been hypothesized that patients with higher physical fitness will present a lower risk of persistent disabling low back pain and so, a lower score on the questionnaire.
- Conditions
- Chronic Low Back Pain, Mechanical Low Back Pain
- Keywords
- chronic low back pain, prognostic factors, disabling low back pain, lumbar muscle activity, start back screening tool, physical evaluation
- 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 |
|---|---|---|
| nonspecific chronic low back pain | Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability level
Oswestry disability index
Measured: 2 months
Disability level
Oswestry disability index
Measured: 4 months
Disability level
Oswestry disability index
Measured: 6 months
Disability level
Oswestry disability index
Measured: 12 months
Secondary outcomes (11)
Pain intensity in the past 2 months
101 points numerical rating scale
Measured: 2 months
Fear of movement level
Tampa scale for kinesiophobia
Measured: 2 months
Patient's global impression of change from baseline
Patient's global impression of change scale
Measured: 6 months
Patient's global impression of change from 6 months
Patient's global impression of change scale
Measured: 12 months
Pain intensity in the past 2 months
101 points numerical rating scale
Measured: 4 months
Pain intensity in the past 2 months
101 points numerical rating scale
Measured: 6 months
Pain intensity in the past 6 months
101 points numerical rating scale
Measured: 12 months
Pain intensity in the past week
101 points numerical rating scale
Measured: 12 months
Fear of movement level
Tampa scale for kinesiophobia
Measured: 4 months
Fear of movement level
Tampa scale for kinesiophobia
Measured: 6 months
Fear of movement level
Tampa scale for kinesiophobia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startOct 2011
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
- Investigators
- Martin Descarreaux, PhD, Principal investigator, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226692
- Sponsor's protocol ID
- UQTR-2011-PFAC
- Status last verified
- May 2015
- First submitted
- 12 Aug 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Page I, Abboud J, O Shaughnessy J, Laurencelle L, Descarreaux M. Chronic low back pain clinical outcomes present higher associations with the STarT Back Screening Tool than with physiologic measures: a 12-month cohort study. BMC Musculoskelet Disord. 2015 Aug 19;16:201. doi: 10.1186/s12891-015-0669-0.
PubMed 26286385
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Poor Prognosis in Patients With Chronic Low Back Pain : Can it be Predicted by Physical Tests and Screening Tools ? - An Observational Study
- ClinicalTrials.gov ID
- NCT02226692
- Acronym / sponsor ID
- UQTR-2011-PFAC
- Conditions
- Chronic Low Back Pain, Mechanical Low Back Pain
- Keywords
- chronic low back pain, prognostic factors, disabling low back pain, lumbar muscle activity, start back screening tool, physical evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Aug 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 aim of the present study is to quantify the relative contribution of variables obtained during a physical fitness evaluation and a short screening questionnaire in determining the short-term and long term risk of persistent disabling low back pain in patients with chronic low back pain. It has been hypothesized that patients with higher physical fitness will present a lower risk of persistent disabling low back pain and so, a lower score on the questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nonspecific chronic low back pain | – | –Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- volunteer with chronic nonspecific low back pain will be recruited among the university's community, its outpatients' chiropractic clinic and through advertisements in the local newspaper. They will first be screened by clinicians at the outpatients' chiropractic clinic in order to assess for the various inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- adults between 18 and 60 years old
- nonspecific low back pain : pain located between the twelfth rib and the inferior gluteal fold for which no specific source of pain could be identified
- chronic low back pain : pain present for 12 weeks or more, and included both constant and recurrent patterns of pain
- able to read and understand French
Key exclusion criteria (14 listed)
- History of surgery or major trauma to the spine
- Current use of medication known to impair physical effort and pain perception
- Lumbar scoliosis of more than 20°
- Collagenosis, severe osteoporosis
- Neuromuscular disease
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
Disability level
Time frame: 2 months
Oswestry disability index
Disability level
Time frame: 4 months
Oswestry disability index
Disability level
Time frame: 6 months
Oswestry disability index
Disability level
Time frame: 12 months
Oswestry disability index
11 secondary outcomes
Pain intensity in the past 2 months
Time frame: 2 months
Fear of movement level
Time frame: 2 months
Patient's global impression of change from baseline
Time frame: 6 months
Patient's global impression of change from 6 months
Time frame: 12 months
Pain intensity in the past 2 months
Time frame: 4 months
Pain intensity in the past 2 months
Time frame: 6 months
Pain intensity in the past 6 months
Time frame: 12 months
Pain intensity in the past week
Time frame: 12 months
Fear of movement level
Time frame: 4 months
Fear of movement level
Time frame: 6 months
Fear of movement level
Time frame: 12 months
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 27 May 2015.
- Derived from this study: PubMed 26286385Page I, Abboud J, O Shaughnessy J, Laurencelle L, Descarreaux M. Chronic low back pain clinical outcomes present higher associations with the STarT Back Screening Tool than with physiologic measures: a 12-month cohort study. BMC Musculoskelet Disord. 2015 Aug 19;16:201. doi: 10.1186/s12891-015-0669-0.
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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.
Martin Descarreaux, PhD principal investigator
Université du Québec à Trois-Rivières
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 Chronic Low Back Pain and Mechanical Low Back Pain, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 4 inclusion and 14 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 27 May 2015. 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 Canada. 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?
Disability level (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02226692, which also lists 1 linked publication.
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 27 May 2015.