Guideline AdherenceNCT03426410
National Recommendations and the Actual Rehabilitation Provided for Low Back Pain Patients
An observational study of Guideline Adherence and Low Back Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
Purpose and background: The purpose of the study is to investigate physiotherapeutic courses of rehabilitation in the primary sector for low back pain patients. This is done by identifying both how physiotherapeutic rehabilitation is organized in the primary sector and further what different types of physiotherapeutic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Guideline Adherence, Low Back Pain
- What is being tested?
- Survey
- How many people
- 230 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Feb 2018to 1 May 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study includes physical therapists in Central Denmark Region working with low back pain rehabilitation in the primary sector, either as a public or a private provider.
Who may be able to join
- physical therapists working with low back pain rehabilitation in the primary sector in Central Denmark Region
Who cannot join
- physical therapists that have less than 1 consultation per week with low back pain patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance Between the National Recommendations and the Actual Rehabilitation Provided for Low Back Pain Patients Referred to Primary Care Rehabilitation. A Survey of Public and Private Health Care Providers in Denmark
Purpose and background:
The purpose of the study is to investigate physiotherapeutic courses of rehabilitation in the primary sector for low back pain patients. This is done by identifying both how physiotherapeutic rehabilitation is organized in the primary sector and further what different types of physiotherapeutic interventions are offered for this patient group. Furthermore the study aims to evaluate to what extent existing physiotherapeutic rehabilitation practice adheres with the national and international guidelines and recommendations for low back pain rehabilitation.
Read more
Methods:
A quantitative survey is carried out, which includes development and validation of a questionnaire for the purpose, and this is subsequently distributed electronically to private and public providers of physiotherapy rehabilitation in all 19 municipalities in Central Denmark Region. Approximately 500 physiotherapists will be asked to participate in the survey in the period February to March 2018.
- Conditions
- Guideline Adherence, Low Back Pain
- Being tested
- Survey
- 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.
SurveyOther
Electronic survey containing a questionnaire regarding knowledge and use of national guidelines of low back pain rehabilitation, type and frequency of cross sectional communication, attitudes and beliefs about back pain and two patient vignettes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline adherence
Adherence to guidelines is assessed on the basis of the responses given to the two patient vignettes in the questionnaire. Thus, for each vignette there is a total 3 questions with four possible answers for each question. For each question 1 answer is correct, 1 partly correct and 2 are wrong. Adherence to guidelines is ultimately defined as:
Strictly adheres = 3 correct answers OR 2 correct and 1 partly correct answer. Partly adheres: 1 correct and 2 partly correct answers OR 2 correct and 1 wrong answer OR 3 partly correct answers.
Does not adhere: any other combination of answers than the above mentioned.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start6 Feb 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guideline AdherenceStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nanna Rolving, PhD, Principal investigator, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426410
- Sponsor's protocol ID
- 6500010
- Status last verified
- Feb 2018
- First submitted
- 1 Feb 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between the National Recommendations and the Actual Rehabilitation Provided for Low Back Pain Patients Referred to Primary Care Rehabilitation. A Survey of Public and Private Health Care Providers in Denmark
- ClinicalTrials.gov ID
- NCT03426410
- Acronym / sponsor ID
- 6500010
- Conditions
- Guideline Adherence, Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- 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.
Purpose and background:
The purpose of the study is to investigate physiotherapeutic courses of rehabilitation in the primary sector for low back pain patients. This is done by identifying both how physiotherapeutic rehabilitation is organized in the primary sector and further what different types of physiotherapeutic interventions are offered for this patient group. Furthermore the study aims to evaluate to what extent existing physiotherapeutic rehabilitation practice adheres with the national and international guidelines and recommendations for low back pain rehabilitation.
Methods:
A quantitative survey is carried out, which includes development and validation of a questionnaire for the purpose, and this is subsequently distributed electronically to private and public providers of physiotherapy rehabilitation in all 19 municipalities in Central Denmark Region. Approximately 500 physiotherapists will be asked to participate in the survey in the period February to March 2018.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes physical therapists in Central Denmark Region working with low back pain rehabilitation in the primary sector, either as a public or a private provider.
Key inclusion criteria (1 listed)
- physical therapists working with low back pain rehabilitation in the primary sector in Central Denmark Region
Key exclusion criteria (1 listed)
- physical therapists that have less than 1 consultation per week with low back pain patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyElectronic survey containing a questionnaire regarding knowledge and use of national guidelines of low back pain rehabilitation, type and frequency of cross sectional communication, attitudes and beliefs about back pain and two patient vignettes. | Other | – |
Primary outcome
Guideline adherence
Time frame: 1 month
Adherence to guidelines is assessed on the basis of the responses given to the two patient vignettes in the questionnaire. Thus, for each vignette there is a total 3 questions with four possible answers for each question. For each question 1 answer is correct, 1 partly correct and 2 are wrong. Adherence to guidelines is ultimately defined as: Strictly adheres = 3 correct answers OR 2 correct and 1 partly correct answer. Partly adheres: 1 correct and 2 partly correct answers OR 2 correct and 1 wrong answer OR 3 partly correct answers. Does not adhere: any other combination of answers than the above mentioned.
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 11 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Nanna Rolving, PhD principal investigator
Silkeborg Regional Hospital
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 Guideline Adherence and Low Back Pain, run by Central Jutland Regional Hospital at 1 site 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 1 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 11 Jun 2018. 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 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?
Guideline adherence (time frame: 1 month). 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 11 Jun 2018.