Low Back PainNCT02168582
Improvement After Physiotherapy for Low Back Pain: The Good Responders
An observational study of Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain. Participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- physiotherapy as usual in primary care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteNorway
- Study dates
- May 2014to 9 Mar 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons seeking primary care physiotherapy because of low back pain.
Who may be able to join
- low back pain
- receiving primary care physiotherapy
Who cannot join
- -
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement After Physiotherapy for Low Back Pain: The Good Responders. An Observational Study in Primary Care
This is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain.
Participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. These observations may help to decide which should be the preferred treatment offered.
- Conditions
- Low Back Pain
- Being tested
- physiotherapy as usual in primary care
- Keywords
- Physical Therapy Modalities, Prognosis, Patient Selection
- 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.
physiotherapy as usual in primary careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| low back pain | Not described Receives: Behavioral: physiotherapy as usual in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported disability
questionnaire (Oswestry Disability Index)
Measured: 1 year
Secondary outcomes (3)
self-efficacy
questionnaire and interview
Measured: 1 year
global perceived effect
questionnaire
Measured: 1 year
quality of life
questionnaire (EQ5D)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2014
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
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.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Trondheim Kommune
- Responsible party
- Sponsor
- Investigators
- Siri Forsmo, prof md, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168582
- Sponsor's protocol ID
- LBP2014
- Status last verified
- Dec 2018
- First submitted
- 18 Jun 2014
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement After Physiotherapy for Low Back Pain: The Good Responders. An Observational Study in Primary Care
- ClinicalTrials.gov ID
- NCT02168582
- Acronym / sponsor ID
- LBP2014
- Conditions
- Low Back Pain
- Keywords
- Physical Therapy Modalities, Prognosis, Patient Selection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Trondheim Kommune
- Study start
- May 2014 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 20 Jun 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.
This is an observational study that aims to characterize individual response of patients getting physical therapy for chronic non-specific low back pain.
Participants will be classified based on a questionnaire and motor tests to investigate whether individual improvement after physical therapy may be predicted. These observations may help to decide which should be the preferred treatment offered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low back pain | – | Behavioral: physiotherapy as usual in primary care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons seeking primary care physiotherapy because of low back pain.
Key inclusion criteria (2 listed)
- low back pain
- receiving primary care physiotherapy
Key exclusion criteria (2 listed)
- -
- -
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 |
|---|---|---|
| physiotherapy as usual in primary care | Behavioural | low back pain |
Primary outcome
patient-reported disability
Time frame: 1 year
questionnaire (Oswestry Disability Index)
3 secondary outcomes
self-efficacy
Time frame: 1 year
global perceived effect
Time frame: 1 year
quality of life
Time frame: 1 year
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 3 Jan 2019.
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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.
Siri Forsmo, prof md study director
Norwegian University of Science and Technology
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 Norwegian University of Science and Technology at 1 site in Norway.
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: finished, as of the sponsor's last update on 3 Jan 2019. 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 Norway. 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?
patient-reported disability (time frame: 1 year). 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 3 Jan 2019.