Low Back PainNCT04034186
The Quality of Physiotherapy in Low Back Pain Patients in Central Finland
An observational study of Low Back Pain, run by Juhani Multanen.
Trial summary
Chronic low back pain is one of the most common musculoskeletal disorders. In the Finnish Health 2000 survey the incidence of low back pain was 10% in men and 11% in women. Several evidence-based rehabilitation guidelines recommend exercise therapy treatment of chronic back pain. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Low Back Pain
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2020
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unspecified chronic (symtoms >12 weeks) low back pain referred to the outpatient clinic in the Department of Physical Medicine and Rehabilitation in Central Finland Hospital, Jyväskylä.
Who may be able to join
- experiencing chronic low back pain,
- ability to communicate in Finnish language
Who cannot join
- previous back surgery in the preceding 12-month
- suspected or diagnosed lumbar disc herniation
About this study
Official title: The Assessment of the Content and Quality of Physiotherapy Management and Advice in Chronic Low-back Pain Patients in Central Finland
Chronic low back pain is one of the most common musculoskeletal disorders. In the Finnish Health 2000 survey the incidence of low back pain was 10% in men and 11% in women. Several evidence-based rehabilitation guidelines recommend exercise therapy treatment of chronic back pain. However, there are no studies in chronic low back pain patients concerning the assessment of the content and quality of exercise modalities adviced in clinical practise.
The aim of this study is to investigate the content and quality of physiotherapy management and advise in chronic low back pain patients in Central Finland.
Read the detailed description
The participants in this study are 100 working-age unspecific low back pain patients from the Central Health Care District, who are referred for specialised care in the outpatient clinic in the Department of Physical Medicine and Rehabilitation in Central Finland Hospital. The participants will be asked to complete health-related questionnaires and an in-house made questionnaire of their back rehabilitation. The main questions are:
- The content about applied exercise modalities,
- How the progression of exercises have been advised?
- How pain was taken into account while exercising? The research will be carried out and coordinated by Central Finland Central Hospital, and the research project will take place between November 2014 and February 2019.
- Conditions
- Low Back Pain
- Keywords
- low back pain, rehabilitation, assessment, quality
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-constructed questionnaire; the content about instructed exercise modalities
Strength training, aerobic exercise, aquatic exercise, mobility or something else
Measured: During the physiotherapy treatment period
Secondary outcomes (2)
Self-constructed questionnaire; the way how the training was instructed by the physiotherapist
Verbally, in written form or by practicing
Measured: During the physiotherapy treatment period
Self-constructed questionnaire; how back pain was taken into account in exercise guidance?
Patient did not receive instructions on how pain should be taken into account while exercising, patient was urged to avoid exercises that caused pain while exercising, patient was urged to exercise within the limits of pain, patient was urged to practice despite the pain, some other instructions - what?
Measured: During the physiotherapy treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study startDec 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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 only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juhani Multanen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juhani Multanen, Central Finland Hospital District
- Investigators
- Jari Ylinen, Docent, Principal investigator, Chief physician in the Department of Physical Medicine and Rehabilitation, Central Finland Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034186
- Sponsor's protocol ID
- Dnro 2E/2014
- Status last verified
- Jul 2019
- First submitted
- 17 Aug 2015
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Content and Quality of Physiotherapy Management and Advice in Chronic Low-back Pain Patients in Central Finland
- ClinicalTrials.gov ID
- NCT04034186
- Acronym / sponsor ID
- Dnro 2E/2014
- Conditions
- Low Back Pain
- Keywords
- low back pain, rehabilitation, assessment, quality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Juhani MultanenUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Jul 2019 (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.
Chronic low back pain is one of the most common musculoskeletal disorders. In the Finnish Health 2000 survey the incidence of low back pain was 10% in men and 11% in women. Several evidence-based rehabilitation guidelines recommend exercise therapy treatment of chronic back pain. However, there are no studies in chronic low back pain patients concerning the assessment of the content and quality of exercise modalities adviced in clinical practise.
The aim of this study is to investigate the content and quality of physiotherapy management and advise in chronic low back pain patients in Central Finland.
Detailed description
The participants in this study are 100 working-age unspecific low back pain patients from the Central Health Care District, who are referred for specialised care in the outpatient clinic in the Department of Physical Medicine and Rehabilitation in Central Finland Hospital. The participants will be asked to complete health-related questionnaires and an in-house made questionnaire of their back rehabilitation. The main questions are:
- The content about applied exercise modalities,
- How the progression of exercises have been advised?
- How pain was taken into account while exercising? The research will be carried out and coordinated by Central Finland Central Hospital, and the research project will take place between November 2014 and February 2019.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unspecified chronic (symtoms >12 weeks) low back pain referred to the outpatient clinic in the Department of Physical Medicine and Rehabilitation in Central Finland Hospital, Jyväskylä.
Key inclusion criteria (2 listed)
- experiencing chronic low back pain,
- ability to communicate in Finnish language
Key exclusion criteria (2 listed)
- previous back surgery in the preceding 12-month
- suspected or diagnosed lumbar disc herniation
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
Self-constructed questionnaire; the content about instructed exercise modalities
Time frame: During the physiotherapy treatment period
Strength training, aerobic exercise, aquatic exercise, mobility or something else
2 secondary outcomes
Self-constructed questionnaire; the way how the training was instructed by the physiotherapist
Time frame: During the physiotherapy treatment period
Self-constructed questionnaire; how back pain was taken into account in exercise guidance?
Time frame: During the physiotherapy treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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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.
Jari Ylinen, Docent principal investigator
Chief physician in the Department of Physical Medicine and Rehabilitation, Central Finland Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Juhani Multanen.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Self-constructed questionnaire; the content about instructed exercise modalities (time frame: During the physiotherapy treatment period). 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 31 Jan 2020.