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Strongest Predictors of a Positive Outcome After Physiotherapy for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03113149
Recruitment Status : Terminated (Recruitment too slow, probably due to the procedure considered too complicated.)
First Posted : April 13, 2017
Last Update Posted : November 24, 2017
University Hospital, Umeå
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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. 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?

Condition or disease
Osteoarthritis, Knee

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Which Factors Are the Strongest Predictors of a Positive Outcome After Physiotherapy for Patients With Knee Osteoarthritis?
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

knee osteoarthritis
Patients with knee osteoarthritis after having started physical therapy

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Patient Specific Functional Scale [ Time Frame: Change from baseline 'Patient Specific Functional Scale' at 3 months ]
    Patient Specific Functional Scale (Stratford, 1995)

  2. Pain intensity [ Time Frame: Change from baseline 'Pain intensity' at 3 months ]
    Pain Intensity scale (Dworkin 2005)

  3. Function of daily living [ Time Frame: Change from baseline 'Function of daily living' at 3 months ]
    Function of daily living scale (KOOS) (Roos & Lohmander 2003)

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Knee OA patients recruited from a private physiotherapy practice in Trondheim, Norway.

Inclusion Criteria:

  1. Clinical and radiological osteoarthritis of the knee and referred to physiotherapists.
  2. Symptomatic daily during the last month.
  3. Symptomatic for more than one year.
  4. Able to walk up and down a flight of 10 stairs with or without walking aids.
  5. Able to walk 3 stairs up and down without walking aids.
  6. Understand Norwegian orally and in writing.
  7. Body mass index below 35.

Exclusion Criteria:

  1. Neurological, rheumatic, orthopedic, or respiratory diagnosis, other than osteoarthritis of the knee which can negatively affect the walking ability, balance or pain.
  2. Body mass index above or equal to 35.
  3. Fracture of the femur or shank, or arthroscopic surgery in the osteoarthritic knee.
  4. Chronic generalized pain (American College of Rheumatology Criteria, 2010).
  5. Inability to understand Norwegian language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03113149

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Department of Neuromedicine and Movement Science, NTNU
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
University Hospital, Umeå
Diakonhjemmet Hospital
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Study Director: Jorunn Helbostad, prof Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology Identifier: NCT03113149     History of Changes
Other Study ID Numbers: 2016/984-1
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Physical Therapy Modalities
Recovery of Function
Predictive Value of Tests
Cohort Studies
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases