Low Back PainNCT02892656
Reliability and Responsiveness of One Questionnaire Used on a Low Back Pain Population
An observational study of Low Back Pain, run by Sano at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- How many people
- 152 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Aug 2017to 28 Feb 2020
- How long will I take part?
- 2 Weeks
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic low back pain (defined as pain lasting for more than 12 months) with or without sciatica and/or with or without generalized pain identified by ICD-10 codes.
Who may be able to join
- referred to The Danish Rheumatism Associations' rehabilitation centre Sano
Who cannot join
- a rated physical status of > 3 according to the American Society of Anesthesiologists Physical Status Classification System
- axial spondyloarthritis
- spinal fracture within the last 3 months
- severe osteoporosis
- active cancer
- active psychiatric pathology assessed by general practitioner before referral
Show all 9Show fewer
- pregnancy
- low Danish language skills
- no e-mail address
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Reliability and Responsiveness of the Danish Version of the Pain Self-Efficacy Questionnaire in Patients With Chronic Low Back Pain
The purpose of this study is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.
Read the detailed description
Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial. CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life.
An important component in rehabilitation is documentation of treatment outcomes. This demands that a change over time can be measured. To determine effect, the measurement tool must detect real or important change over time. This requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. If the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool.
The measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with CLBP.
It is found necessary to determine the reliability and responsiveness of the PSEQ on the CLBP population referred to Sano Aarhus. Data will be electronically entered in, stored in and collected from Sanos internal database (SanoBasen).
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Self-efficacy questionnaire
The PSEQ consists of 10 items, each item is scored on a seven-point Likert scale with responses ranging from 0 (not at all confident) to 6 (completely confident). A total score is calculated by summing the scores of the 10 items yielding a total sum score ranging from 0-60. Higher scores indicate a stronger self-efficacy belief
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 posted8 Sep 2016 (estimated)
- Study start10 Aug 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
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 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
- 152 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Sano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Mette Schmidt, Msc. H.S., Principal investigator, Sano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892656
- Sponsor's protocol ID
- Sano 2
- Status last verified
- Aug 2020
- First submitted
- 2 Sep 2016
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vejlgaard C, Maribo T, Riisgaard Laursen J, Schmidt AM. Reliability and smallest detectable change of the Danish version of the Pain Self-Efficacy Questionnaire in patients with chronic low back pain. Scand J Pain. 2021 Jun 2;21(4):809-813. doi: 10.1515/sjpain-2021-0014. Print 2021 Oct 26.
PubMed 34062626
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Responsiveness of the Danish Version of the Pain Self-Efficacy Questionnaire in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02892656
- Acronym / sponsor ID
- Sano 2
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- SanoUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 8 Sep 2016 (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 is to determine the reliability and responsiveness of the Pain Self-Efficacy Questionnaire (PSEQ) in a chronic low back pain (CLBP) population referred to The Danish Rheumatism Associations´ rehabilitation centre Sano Aarhus.
Detailed description
Chronic low back pain (CLBP) is a highly prevalent health condition, and the leading cause of years lived with disability both globally and in Denmark. In the majority of patients with CLBP, no underlying pathology or cause can be identified and CLBP is acknowledged to be multifactorial. CLBP is defined by symptoms lasting for a period longer than three months. The high prevalence of CLBP causes a substantial impact on patients and their families, communities and health-care systems, as well as a financial burden. Besides pain and disability people with CLBP often experience psychosocial consequences with signs of anxiety and depression and effects on social, leisure, and work life.
An important component in rehabilitation is documentation of treatment outcomes. This demands that a change over time can be measured. To determine effect, the measurement tool must detect real or important change over time. This requires the measurement tool is reliable, and therefore will show no real or important change in periods where the patient is stable. If the measurement tool shows real or important change, in periods where there is no change in the patient state, the results can not be predicted as an effect from an intervention, but due to uncertainty of measurement tool.
The measurement tool is selected by the recommendation of literature and involvement of clinicians and patients at sano, and examines patient with CLBP.
It is found necessary to determine the reliability and responsiveness of the PSEQ on the CLBP population referred to Sano Aarhus. Data will be electronically entered in, stored in and collected from Sanos internal database (SanoBasen).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic low back pain (defined as pain lasting for more than 12 months) with or without sciatica and/or with or without generalized pain identified by ICD-10 codes.
Key inclusion criteria (1 listed)
- referred to The Danish Rheumatism Associations' rehabilitation centre Sano
Key exclusion criteria (9 listed)
- a rated physical status of > 3 according to the American Society of Anesthesiologists Physical Status Classification System
- axial spondyloarthritis
- spinal fracture within the last 3 months
- severe osteoporosis
- active cancer
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
Pain Self-efficacy questionnaire
Time frame: 12 months
The PSEQ consists of 10 items, each item is scored on a seven-point Likert scale with responses ranging from 0 (not at all confident) to 6 (completely confident). A total score is calculated by summing the scores of the 10 items yielding a total sum score ranging from 0-60. Higher scores indicate a stronger self-efficacy belief
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 Aug 2020.
- Derived from this study: PubMed 34062626Vejlgaard C, Maribo T, Riisgaard Laursen J, Schmidt AM. Reliability and smallest detectable change of the Danish version of the Pain Self-Efficacy Questionnaire in patients with chronic low back pain. Scand J Pain. 2021 Jun 2;21(4):809-813. doi: 10.1515/sjpain-2021-0014. Print 2021 Oct 26.
- Individual participant dataSharing planned: No
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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.
Anne Mette Schmidt, Msc. H.S. principal investigator
Sano
2 sites 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 Sano at 2 sites in Denmark.
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 1 inclusion and 9 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Pain Self-efficacy questionnaire (time frame: 12 months). 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 NCT02892656, 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 17 Aug 2020.