Osteoarthritis, KneeNCT03113149
Strongest Predictors of a Positive Outcome After Physiotherapy for Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Individuals with painful knee osteoarthritis (OA) experience restricted physical function. Few previous studies have investigated comprehensive sets of constructs and tests to investigate physical function in these patients. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2017to 31 Aug 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Knee OA patients recruited from a private physiotherapy practice in Trondheim, Norway.
Who may be able to join
- Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.
- Symptomatic daily during the last month.
- Symptomatic for more than one year.
- Able to walk up and down a flight of 10 stairs with or without walking aids.
- Able to walk 3 stairs up and down without walking aids.
- Understand Norwegian orally and in writing.
- Body mass index below 35.
Who cannot join
- Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain.
- Body mass index above or equal to 35.
- Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.
- Chronic generalized pain (American College of Rheumatology Criteria, 2010).
- Inability to understand Norwegian language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which Factors Are the Strongest Predictors of a Positive Outcome After Physiotherapy for Patients With Knee Osteoarthritis?
Individuals with painful knee osteoarthritis (OA) experience restricted physical function. Few previous studies have investigated comprehensive sets of constructs and tests to investigate physical function in these patients. Most single studies of knee OA patients show limited scope for explaining physical function in the perspective of WHO's International Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the bodily level), Activities (individual level), and Participation (societal level). On the bodily level there is limited case-control knowledge on muscle strength beyond the knee and endurance-strength in general. On the activity level, there is similar limitation of biomechanical bodily features in stair climbing. On the participation level the situation is similar for objective performance. Measures are needed that inter-relate all three levels of ICF. These should also include well discriminating tests e.g. knee strength, walking, and activities of daily life (ADL), as well as both objective and subjective measures.
The purpose of this study is to explore mechanisms that can explain physical function in patients with knee OA in primary care. The study's main and primary goal is to quantify which baseline factors and change scores are the strongest predictors of a positive treatment outcome in terms of patients' global perceived change after physiotherapy. Secondary research question is: which factors are the strongest predictors of a positive outcome of physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and function in daily living?
- Conditions
- Osteoarthritis, Knee
- Keywords
- Physical Therapy Modalities, Recovery of Function, Predictive Value of Tests, Cohort Studies
- Medical subject headings
- Osteoarthritis, Knee
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 |
|---|---|---|
| knee osteoarthritis | Patients with knee osteoarthritis after having started physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient global perceived effect
patient global perceived effect scale (Dworkin 2005, Evans 2014)
Measured: Change from baseline 'patient global perceived effect' at 3 months
Secondary outcomes (3)
Patient Specific Functional Scale
Patient Specific Functional Scale (Stratford, 1995)
Measured: Change from baseline 'Patient Specific Functional Scale' at 3 months
Pain intensity
Pain Intensity scale (Dworkin 2005)
Measured: Change from baseline 'Pain intensity' at 3 months
Function of daily living
Function of daily living scale (KOOS) (Roos \& Lohmander 2003)
Measured: Change from baseline 'Function of daily living' at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 May 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Why it stopped: Recruitment too slow, probably due to the procedure considered too complicated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå, Diakonhjemmet Hospital
- Responsible party
- Sponsor
- Investigators
- Jorunn Helbostad, prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113149
- Sponsor's protocol ID
- 2016/984-1
- Status last verified
- Nov 2017
- First submitted
- 4 Apr 2017
- Last updated
- 24 Nov 2017
- 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 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Factors Are the Strongest Predictors of a Positive Outcome After Physiotherapy for Patients With Knee Osteoarthritis?
- ClinicalTrials.gov ID
- NCT03113149
- Acronym / sponsor ID
- 2016/984-1
- Conditions
- Osteoarthritis, Knee
- Keywords
- Physical Therapy Modalities, Recovery of Function, Predictive Value of Tests, Cohort Studies
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment too slow, probably due to the procedure considered too complicated.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University Hospital, Umeå, Diakonhjemmet Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 13 Apr 2017 (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.
Individuals with painful knee osteoarthritis (OA) experience restricted physical function. Few previous studies have investigated comprehensive sets of constructs and tests to investigate physical function in these patients. Most single studies of knee OA patients show limited scope for explaining physical function in the perspective of WHO's International Classification of Functioning, Disability and Health (ICF) 3 levels: Body functions (the bodily level), Activities (individual level), and Participation (societal level). On the bodily level there is limited case-control knowledge on muscle strength beyond the knee and endurance-strength in general. On the activity level, there is similar limitation of biomechanical bodily features in stair climbing. On the participation level the situation is similar for objective performance. Measures are needed that inter-relate all three levels of ICF. These should also include well discriminating tests e.g. knee strength, walking, and activities of daily life (ADL), as well as both objective and subjective measures.
The purpose of this study is to explore mechanisms that can explain physical function in patients with knee OA in primary care. The study's main and primary goal is to quantify which baseline factors and change scores are the strongest predictors of a positive treatment outcome in terms of patients' global perceived change after physiotherapy. Secondary research question is: which factors are the strongest predictors of a positive outcome of physiotherapy in knee OA, in terms of pain intensity, patient specific functional scale, and function in daily living?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis | – | –Patients with knee osteoarthritis after having started physical therapy |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Knee OA patients recruited from a private physiotherapy practice in Trondheim, Norway.
Key inclusion criteria (7 listed)
- Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.
- Symptomatic daily during the last month.
- Symptomatic for more than one year.
- Able to walk up and down a flight of 10 stairs with or without walking aids.
- Able to walk 3 stairs up and down without walking aids.
Key exclusion criteria (5 listed)
- Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain.
- Body mass index above or equal to 35.
- Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.
- Chronic generalized pain (American College of Rheumatology Criteria, 2010).
- Inability to understand Norwegian language.
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
patient global perceived effect
Time frame: Change from baseline 'patient global perceived effect' at 3 months
patient global perceived effect scale (Dworkin 2005, Evans 2014)
3 secondary outcomes
Patient Specific Functional Scale
Time frame: Change from baseline 'Patient Specific Functional Scale' at 3 months
Pain intensity
Time frame: Change from baseline 'Pain intensity' at 3 months
Function of daily living
Time frame: Change from baseline 'Function of daily living' at 3 months
Results and safety
The study was stopped early (reason given: Recruitment too slow, probably due to the procedure considered too complicated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- 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.
Jorunn Helbostad, prof 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 Osteoarthritis, Knee, 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Nov 2017. 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 was stopped early (reason given: Recruitment too slow, probably due to the procedure considered too complicated.). 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?
patient global perceived effect (time frame: Change from baseline 'patient global perceived effect' at 3 months). 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 24 Nov 2017.